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Sample records for center feasibility trial

  1. Feasibility support for multi-center trials in the Netherlands

    NARCIS (Netherlands)

    Dijk, WA; van der Velde, W; Dassen, WRM; Spruijt, HJ; Baljon, MH

    2000-01-01

    This paper describes a feasibility support module for multi-center clinical trials in the Netherlands. Ir is a subproject within a large Electronic Patient Record for Cardiology project. The setup is based on the fact that each participating center has its own departmental information system.

  2. Shared Cared for Stable Glaucoma Patients: Economic Benefits and Patient-centered Outcomes of a Feasibility Trial.

    Science.gov (United States)

    Goh, David; de Korne, Dirk F; Ho, Henrietta; Mathur, Ranjana; Chakraborty, Bibhas; Van Hai, Nguyen; Wai, Charity; Perera, Shamira; Aung, Tin; Wong, Tien Y; Lamoureux, Ecosse L

    2018-02-01

    The purpose of this article is to assess the quality of care and economic benefits of a shared care model managing patients with stable glaucoma in a primary eye care (PEC) clinic compared with a tertiary specialist outpatient clinic (SOC) in Singapore. A randomized equivalence feasibility trial was preformed comparing the PEC with SOC models. Participants recruited from the SOC had no visual field progression or change in management for at least 3 years, were on a maximum of a single glaucoma medication, had no previous tube-shunt implant and were at least 3-year posttrabeculectomy surgery.Primary outcomes were clinical assessment and management, economic benefits, and patient satisfaction. Differences were analyzed using equivalence testing and generalized odds ratios. The trial included 233 patients, consisting of 42.1% glaucoma disc suspects (PEC: 47.4%; SOC: 36.8%), 27.5% primary angle closure suspects (PEC: 25.0%; SOC: 29.9%), 13.7% with ocular hypertension (PEC: 13.8%; SOC: 13.7%), 3.9% with primary angle closure glaucoma (PEC: 4.3%; SOC: 3.4%), and 3.0% with primary open angle glaucoma (PEC: 1.7%; SOC: 4.3%). Glaucoma clinical care for patients at PEC was as good as SOC [rate difference, 6.83%; 95% confidence interval (CI), 2.84-11.12) and management (rate difference, 7.69%; 95% CI, 3.21-12.17). In 23 cases (9.9%), 5.2% at PEC and 14.5% at SOC, there was disconcordance with the gold standard of senior consultant. Patient satisfaction at the PEC was equally high when compared with SOC (generalized odds ratio, 1.43; CI, 0.50-2.00). Direct costs per patient visit were 43% lower at PEC compared with SOC. Managing stable glaucoma patients at a primary care setting is a cost saving, safe, and effective shared care while enhancing professional collaboration between hospital and community settings.

  3. Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

    NARCIS (Netherlands)

    Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

    2016-01-01

    OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

  4. Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements.

    Science.gov (United States)

    Nieuwenhuis, Joost B; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

    2016-09-01

    To illustrate how pragmatic trial design elements or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision, and operational feasibility. From illustrative examples identified through the IMI Get Real Consortium, we selected randomized drug trials with a pragmatic design feature. We searched all publications on these trials for information on how pragmatic trial design features affect validity, generalizability, precision, or feasibility. We present examples from the Salford lung study, International Suicide Prevention Trial, Sequenced Treatment Alternatives to Relieve Depression, and Cluster Randomized Usual care vs. Caduet Investigation Assessing Long-term-risk trial. These examples show that incorporating pragmatic trial design elements in trials may affect generalizability, precision and validity and may lead to operational challenges different from traditional explanatory trials. Inserting explanatory trial elements into pragmatic trials may also affect validity, generalizability, and operational feasibility, especially when these trial elements are incorporated in one arm of the trial only. Design choices that positively affect one of these domains (e.g., generalizability) may negatively affect others (e.g., feasibility). Consequences of incorporating pragmatic or explanatory trial design elements in pragmatic trials should be explicitly considered and balanced for all relevant domains, including validity, generalizability, precision, and operational feasibility. Tools are needed to make these consequences more transparent. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. A feasibility study for a manufacturing technology deployment center

    Energy Technology Data Exchange (ETDEWEB)

    1994-10-31

    The Automation & Robotics Research Institute (ARRI) and the Texas Engineering Extension Service (TEEX) were funded by the U.S. Department of Energy to determine the feasibility of a regional industrial technology institute to be located at the Superconducting Super Collider (SSC) Central Facility in Waxahachie, Texas. In response to this opportunity, ARRI and TEEX teamed with the DOE Kansas City Plant (managed by Allied Signal, Inc.), Los Alamos National Laboratory (managed by the University of California), Vought Aircraft Company, National Center for Manufacturing Sciences (NCMS), SSC Laboratory, KPMG Peat Marwick, Dallas County Community College, Navarro Community College, Texas Department of Commerce (TDOC), Texas Manufacturing Assistance Center (TMAC), Oklahoma Center for the Advancement of Science and Technology, Arkansas Science and Technology Authority, Louisiana Productivity Center, and the NASA Mid-Continent Technology Transfer Center (MCTTC) to develop a series of options, perform the feasibility analysis and secure industrial reviews of the selected concepts. The final report for this study is presented in three sections: Executive Summary, Business Plan, and Technical Plan. The results from the analysis of the proposed concept support the recommendation of creating a regional technology alliance formed by the states of Texas, New Mexico, Oklahoma, Arkansas and Louisiana through the conversion of the SSC Central facility into a Manufacturing Technology Deployment Center (MTDC).

  6. Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

    Science.gov (United States)

    Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

    2016-01-01

    To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  7. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial

    National Research Council Canada - National Science Library

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-01-01

    .... The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy...

  8. Walking is a Feasible Physical Activity for People with Rheumatoid Arthritis: A Feasibility Randomized Controlled Trial.

    Science.gov (United States)

    Baxter, Susan V; Hale, Leigh A; Stebbings, Simon; Gray, Andrew R; Smith, Catherine M; Treharne, Gareth J

    2016-03-01

    Exercise has been recognized as important in the management of rheumatoid arthritis (RA). Walking is a low-cost and low-impact activity, requiring little supervision. It requires no specialist training, is suited to a variety of environments and is inherently a clinically meaningful measure of independence. The aim of the present study was to determine whether a designed walking programme for people with RA successfully facilitated regular physical activity in participants, without detriment to pain levels. Thirty-three people with RA were recruited from Dunedin Hospital rheumatology outpatient clinics and enrolled in a walking randomized controlled trial (RCT) feasibility study. Participants were randomly allocated to the walking intervention (n = 11) or control (n = 22) groups. Control participants received a nutrition education session, and the walking intervention group received instructions on a walking route with three loops, to be completed 3-4 times per week. The walking route shape was designed so that the length of the walk could be tailored by participants. Both groups were assessed at baseline and six weeks later. The primary outcome measures were feasibility, acceptability and safety. The principal secondary outcome was change in walking speed after the intervention. Additional outcome measures were a step-up test, activity limitations (on the Health Assessment Questionnaire), global well-being (on the European Quality of Life Questionnaire), self-efficacy for managing arthritis symptoms, self-efficacy for physical activity, daily pedometer readings and a daily visual analogue scale for pain. Participants successfully completed the walk for the suggested frequency, indicating feasibility and acceptability. There were no reported adverse effects of participation and the walking intervention group did not have higher daily pain levels than the control group, indicating safety. The walking intervention group showed a pattern of improvements in

  9. Oregon High Desert Interpretive Center : Economic feasibility and impact analysis

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This is a proposal to construct a High Desert Interpretive Center to inform visitors to Harney County, Oregon of the opportunities for education, recreation and...

  10. Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

    Science.gov (United States)

    Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

    2017-08-01

    The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a

  11. Predicting Recruitment Feasibility for Acute Spinal Cord Injury Clinical Trials in Canada Using National Registry Data.

    Science.gov (United States)

    Thibault-Halman, Ginette; Rivers, Carly S; Bailey, Christopher S; Tsai, Eve C; Drew, Brian; Noonan, Vanessa K; Fehlings, Michael G; Dvorak, Marcel F; Kuerban, Dilinuer; Kwon, Brian K; Christie, Sean D

    2017-02-01

    Traumatic spinal cord injury (SCI) represents a significant burden of illness, but it is relatively uncommon and heterogeneous, making it challenging to achieve sufficient subject enrollment in clinical trials of therapeutic interventions for acute SCI. The Rick Hansen Spinal Cord Injury Registry (RHSCIR) is a national SCI Registry that enters patients with SCI from acute-care centers across Canada. To predict the feasibility of conducting clinical trials of acute SCI within Canada, we have applied the inclusion/exclusion criteria of six previously conducted SCI trials to the RHSCIR data set and generated estimates of how many Canadian persons would have been eligible theoretically for enrollment in these studies. Data for SCI cases were prospectively collected for RHSCIR at 18 acute and 13 rehabilitation sites across Canada. RHSCIR patients enrolled between 2009-2013 who met the following key criteria were included: non-penetrating traumatic SCI; received acute care at a RHSCIR site; age more than 18, less than 75 years, and had complete admission single neurological level of injury data. Inclusion and exclusion criteria for the Minocycline in Acute Spinal Cord injury (Minocycline), Riluzole, Surgical Timing in Acute Spinal Cord Injury Study (STASCIS), Cethrin, Nogo antibody study (NOGO), and Sygen studies were applied retrospectively to this data set. The numbers of patients eligible for each clinical trial were determined. There were 2166 of the initial 2714 patients (79.8%) who met the key criteria and were included in the data set. Projected annual numbers of eligible patients for each trial were: Minocycline, 117; Riluzole, 62; STASCIS, 109; Cethrin, 101; NOGO, 82; and Sygen, 70. An additional 8.0% of the sample had a major head injury (Glasgow Coma Scale [GCS] score ≤12) and would have been excluded from the trials. RHSCIR provides a comprehensive national data set that may serve as a useful tool in the planning of multicenter clinical SCI trials.

  12. Predicting enrollment performance of investigational centers in phase III multi-center clinical trials

    Directory of Open Access Journals (Sweden)

    Rutger M. van den Bor

    2017-09-01

    Full Text Available Failure to meet subject recruitment targets in clinical trials continues to be a widespread problem with potentially serious scientific, logistical, financial and ethical consequences. On the operational level, enrollment-related issues may be mitigated by careful site selection and by allocating monitoring or training resources proportionally to the anticipated risk of poor enrollment. Such procedures require estimates of the expected recruitment performance that are sufficiently reliable to allow centers to be sensibly categorized. In this study, we investigate whether information obtained from feasibility questionnaires can potentially be used to predict which centers will and which centers will not meet their enrollment targets by means of multivariable logistic regression analysis. From a large set of 59 candidate predictors, we determined the subset that is optimal for predictive purposes using Least Absolute Shrinkage and Selection Operator (LASSO regularization. Although the extent to which the results are generalizable remains to be determined, they indicate that the prediction accuracy of the optimal model is only a marginal improvement over the intercept-only model, illustrating the difficulty of prediction in this setting.

  13. Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial.

    Science.gov (United States)

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Szturm, Tony

    2016-09-13

    To examine the feasibility of a clinical trial on a novel, home-based task-oriented training with conventional hand exercises in people with rheumatoid arthritis or hand osteoarthritis. To explore the experiences of participants who completed their respective home exercise programmes. Thirty volunteer participants aged between 30 and 60 years and diagnosed with rheumatoid arthritis or hand osteoarthritis were proposed for a single-center, assessor-blinded, randomized controlled trial ( ClinicalTrials.gov : NCT01635582). Participants received task-oriented training with interactive computer games and objects of daily life or finger mobility and strengthening exercises. Both programmes were home based and were done four sessions per week with 20 minutes each session for 6 weeks. Major feasibility outcomes were number of volunteers screened, randomized, and retained; completion of blinded assessments, exercise training, and home exercise sessions; equipment and data management; and clinical outcomes of hand function. Reaching the recruitment target in 18 months and achieving exercise compliance >80% were set as success criteria. Concurrent with the trial, focus group interviews explored experiences of those participants who completed their respective programmes. After trial initiation, revisions in inclusion criteria were required to promote recruitment. A total of 17 participants were randomized and 15 were retained. Completion of assessments, exercise training, and home exercise sessions; equipment and data collection and management demonstrated excellent feasibility. Both groups improved in hand function outcomes and exercise compliance was above 85%. Participants perceived both programmes as appropriate and acceptable. Participants who completed task-oriented training also agreed that playing different computer games was enjoyable, engaging, and motivating. Findings demonstrate initial evidence on recruitment, feasibility of trial procedures, and acceptability of

  14. Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

    Directory of Open Access Journals (Sweden)

    Gloria Omosa-Manyonyi

    Full Text Available Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.The Kenya AIDS Vaccine Initiative (KAVI enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal, but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79% and 62 of 71 men (87% enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48% at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63% at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52% gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24% at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits.Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

  15. Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

    Science.gov (United States)

    Omosa-Manyonyi, Gloria; Park, Harriet; Mutua, Gaudensia; Farah, Bashir; Bergin, Philip J; Laufer, Dagna; Lehrman, Jennifer; Chinyenze, Kundai; Barin, Burc; Fast, Pat; Gilmour, Jill; Anzala, Omu

    2014-01-01

    Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections. The Kenya AIDS Vaccine Initiative (KAVI) enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal), but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79%) and 62 of 71 men (87%) enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48%) at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63%) at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52%) gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24%) at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits. Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

  16. Study protocol for the nutritional route in oesophageal resection trial: a single-arm feasibility trial (NUTRIENT trial)

    Science.gov (United States)

    Weijs, Teus J; Nieuwenhuijzen, Grard A P; Ruurda, Jelle P; Kouwenhoven, Ewout A; Rosman, Camiel; Sosef, Meindert; v Hillegersberg, Richard; Luyer, Misha D P

    2014-01-01

    Introduction The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy. Methods and analysis This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered. Ethics and dissemination Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the study has been registered at the Dutch Trial Register, NTR4136. Results will be published and presented at international congresses. Discussion We hypothesise that the oral route of feeding is safe and feasible following oesophagectomy, as has been shown previously for other types of gastrointestinal surgery. It is expected that early oral nutrition will result in enhanced recovery. Furthermore, complications related to artificial feeding, such as jejunostomy tube feeding, are believed to be reduced. However, (aspiration) pneumonia and anastomotic leakage are potential risks that are carefully monitored. Trial registration number NTR4136. PMID:24907243

  17. The PACT trial: PAtient Centered Telerehabilitation

    Directory of Open Access Journals (Sweden)

    Andreas Stefan Rothgangel

    2015-01-01

    Discussion: Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.

  18. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  19. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  20. Feasibility

    OpenAIRE

    Bokdam, J.; Braeckel, van, Liesbeth

    2002-01-01

    Extensive livestock farming, including hay making, seems the most feasible management strategy for open peatland. In the longer term, wilderness grazing may become more feasible. The loss of economic viability of traditional livestock farming and related haymaking may be reversed by innovation of new marketable 'Biebrza' products, 'green services', e.g. eco- and agro-tourism, and by financial subventions by the EU and the Polish Government. Large scale mechanical harvesting of hay and litter ...

  1. Tackling Social Cognition in Schizophrenia: A Randomized Feasibility Trial.

    Science.gov (United States)

    Taylor, Rumina; Cella, Matteo; Csipke, Emese; Heriot-Maitland, Charles; Gibbs, Caroline; Wykes, Til

    2016-05-01

    Social cognition difficulties in schizophrenia are seen as a barrier to recovery. Intervention tackling problems in this domain have the potential to facilitate functioning and recovery. Social Cognition and Interaction Training (SCIT) is a manual-based psychological therapy designed to improve social functioning in schizophrenia. The aim of this study is to evaluate the feasibility and acceptability of a modified version of SCIT for inpatient forensic wards. The potential benefits of the intervention were also assessed. This study is a randomized single blind controlled design, with participants randomized to receive SCIT (N = 21) or treatment as usual (TAU; N = 15). SCIT consisted of 8-week therapy sessions twice per week. Participants were assessed at week 0 and one week after the intervention on measures of social cognition. Feasibility was assessed through group attendance and attrition. Participant acceptability and outcome was evaluated through post-group satisfaction and achievement of social goals. The intervention was well received by all participants and the majority reported their confidence improved. The SCIT group showed a significant improvement in facial affect recognition compared to TAU. Almost all participants agreed they had achieved their social goal as a result of the intervention. It is feasible to deliver SCIT in a forensic ward setting; however, some adaptation to the protocol may need to be considered in order to accommodate for the reduced social contact within forensic wards. Practice of social cognition skills in real life may be necessary to achieve benefits to theory of mind and attributional style.

  2. Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial.

    Science.gov (United States)

    Friedli, Karin; Guirguis, Ayman; Almond, Michael; Day, Clara; Chilcot, Joseph; Da Silva-Gane, Maria; Davenport, Andrew; Fineberg, Naomi A; Spencer, Benjamin; Wellsted, David; Farrington, Ken

    2017-02-07

    Depression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness. Patients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ≥16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial. In total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ≥16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (PDepression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (Pdepressed patients already taking antidepressants. Copyright © 2017 by the American Society of Nephrology.

  3. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

    Directory of Open Access Journals (Sweden)

    McCarren M

    2014-10-01

    Full Text Available Madeline McCarren,1 Elaine L Twedt,1 Faizmohamed M Mansuri,2 Philip R Nelson,3 Brian T Peek3 1Pharmacy Benefits Management Services, Department of Veterans Affairs, Hines, IL, 2Wilkes-Barre VA Medical Center, Wilkes-Barre, PA, 3Charles George VA Medical Center, Asheville, NC, USA Purpose: Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers to “favor” a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design.Subjects and methods: Agreeable providers were randomized to “favor” either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate.Results: All four institutional review boards waived documentation of patient consent. Providers (n=18 followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients. In the “favor hydrochlorothiazide” group, there was 99% adherence to that strategy. In the “favor chlorthalidone” group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25–50 mg/day and 100% for chlorthalidone (12.5–25.0 mg/day. Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information

  4. A centralised public information resource for randomised trials: a scoping study to explore desirability and feasibility

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2005-05-01

    Full Text Available Abstract Background There are currently several concerns about the ways in which people are recruited to participate in randomised controlled trials, the low acceptance rates among people invited to participate, and the experiences of trial participants. An information resource about on-going clinical trials designed for potential and current participants could help overcome some of these problems. Methods We carried out a scoping exercise to explore the desirability and feasibility of establishing such a resource. We sought the views of a range of people including people who were considering taking part in a trial, current trial participants, people who had been asked but refused to participate in a trial, consumer group representatives and researchers who design and conduct trials. Results There was broad-based support for the concept of a centralised information resource for members of the public about on-going and recently completed clinical trials. Such an information resource could be based on a database containing standardised information for each trial relating to the purpose of the trial; the interventions being compared; the implications of participation for participants; and features indicative of scientific quality and ethical probity. The usefulness of the database could be enhanced if its search facility could allow people to enter criteria such as a disease and geographic area and be presented with all the trials relevant to them, and if optional display formats could allow them to view information in varying levels of detail. Access via the Internet was considered desirable, with complementary supported access via health information services. The development of such a resource is technically feasible, but the collation of the required information would take a significant investment of resources. Conclusion A centralised participant oriented information resource about clinical trials could serve several purposes. A more detailed

  5. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-03-07

    A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity

  6. Contract administration involving the remedial investigation and feasibility study at the Feed Materials Production Center

    Energy Technology Data Exchange (ETDEWEB)

    1991-08-28

    Advanced Sciences, Incorporated (ASI), has been performing a Remedial Investigation and Feasibility Study (RI/FS) at the Feed Materials Production Center (Fernald Facility) at Fernald, Ohio, under an 8 (a) contract with the US Small Business Administration (SBA). The Fernald Facility is a Government-owned facility operated by Westinghouse Materials Company of Ohio (WMCO) under a management and operating contract. The objective of this audit was to evaluate the award and administration of the ASI contract.

  7. The effectiveness of a lumbopelvic monitor and feedback device to change postural behavior: a feasibility randomized controlled trial.

    Science.gov (United States)

    Ribeiro, Daniel Cury; Sole, Gisela; Abbott, J Haxby; Milosavljevic, Stephan

    2014-09-01

    Feasibility randomized controlled trial. To assess the feasibility of a trial to investigate the effectiveness of a lumbopelvic monitor as a feedback device for modifying postural behavior during daily work-related activities. Frequent or sustained flexed postures play a role in the development or maintenance of nonspecific low back pain. The provision of postural feedback could help individuals with or at risk of nonspecific low back pain improve their postural awareness and avoid hazardous or pain-provoking postures. Sixty-two participants employed in a health care organization were randomly allocated into 1 of 3 groups: a control group, an intermittent feedback group, and a constant feedback group. Adherence and follow-up rates were assessed. Differences in postural pattern between baseline and follow-up measurements were used to assess the effectiveness of the lumbopelvic monitor as a postural feedback device. Adherence was approximately 75%. With the exception of 1 center, the follow-up overall rates exceeded the a priori desired threshold of 80%. Within-group comparisons revealed no significant differences in postural pattern for the control group and intermittent feedback group. The constant feedback group showed a significant reduction in flexed posture at the follow-up period compared with the baseline period. Differences between groups did not reach statistical significance; however, the constant feedback group, compared with the control group, demonstrated an effect size (d) of 0.60. The provision of constant postural feedback seems promising for promoting changes in postural behavior. This feasibility trial identified adherence and follow-up rates and sample-size estimates important to the conduct of a fully powered efficacy trial. Level of Evidence Therapy, level 2b-.

  8. A 12-week interdisciplinary rehabilitation trial in patients with gliomas - a feasibility study.

    Science.gov (United States)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek; Jarden, Jens Ole

    2017-03-12

    This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.

  9. Toward a centralized database for child safety centers: Results of a feasibility pilot study.

    Science.gov (United States)

    McDonald, Eileen M; Gittelman, Michael A; Rains, Catherine M; Hoffman, Benjamin D; Zonfrillo, Mark R

    2015-09-01

    Safety centers (SCs) are hospital-affiliated outlets that provide families with safety products and personalized education about preventing injuries. Roughly 40 SCs are in operation across the United States, but no single model for staffing, supplying, or sustaining them has emerged. The project aimed to determine the feasibility of a centralized database for SC evaluation as the first step toward growing this proven intervention. An Expert Advisory Committee was convened to determine data collection elements and procedures. Representatives from nine hospital-based SCs collected data about car seat and bike helmet sales and education provided between August 1, 2013, to December 31, 2013. A total of 645 study-related safety products were distributed at cost (72%), below cost (10%), or for free (19%). Education was provided for 96% of all products distributed, including receipt of print materials (81%) and product demonstrations (83%). Visitors to SCs were usually referred by a hospital provider (34%), followed by word of mouth (24%) and walk-in (22%). Seven of nine SCs were able to contribute data. Stability of SCs and capacity of staff emerged as facilitators of centralized data collection feasibility. We demonstrate that centralized data collection is feasible and that information to compare centers can be obtained. However, for more meaningful comparisons to emerge and to enable all SCs the ability to participate, support is needed institutionally for staff to be able to capture data and nationally to grow and sustain a database that represents the broader diversity of topics and services offered.

  10. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

    Science.gov (United States)

    Eldridge, Sandra M.; Lancaster, Gillian A.; Campbell, Michael J.; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L.; Bond, Christine M.

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention. PMID:26978655

  11. A randomized controlled feasibility trial exploring partnered ballroom dancing for people with Parkinson's disease.

    Science.gov (United States)

    Kunkel, D; Fitton, C; Roberts, L; Pickering, R M; Roberts, H C; Wiles, R; Hulbert, S; Robison, J; Ashburn, A

    2017-10-01

    To determine the feasibility of a Dance Centre delivering a programme of mixed dances to people with Parkinson's and identify suitable outcomes for a future definitive trial. A two-group randomized controlled feasibility trial. People with Parkinson's were randomized to a control or experimental group (ratio 15:35), alongside usual care. In addition, participants in the experimental group danced with a partner for one hour, twice-a-week for 10 weeks; professional dance teachers led the classes and field-notes were kept. Control-group participants were given dance class vouchers at the end of the study. Blinded assessments of balance, mobility and function were completed in the home. Qualitative interviews were conducted with a subsample to explore the acceptability of dance. A total of 51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years), were recruited to the study. Dance partners were of similar age (mean 68, range 56-91 years). Feasibility findings focused on recruitment (target achieved); retention (five people dropped out of dancing); outcome measures (three measures were considered feasible, changes were recommended). Proposed sample size for a Phase III trial, based on the 6-minute walk test at six months was 220. Participants described dance as extremely enjoyable and the instructors were skilled in instilling confidence and motivation. The main organizational challenges for a future trial were transport and identifying suitable dance partners. We have demonstrated the feasibility of conducting the study through a Dance Centre and recommend a Phase III trial.

  12. Feasibility, Safety, and Compliance in a Randomized Controlled Trial of Physical Therapy for Parkinson's Disease

    Directory of Open Access Journals (Sweden)

    Jennifer L. McGinley

    2012-01-01

    Full Text Available Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD (n=210 were randomized into three groups: (1 progressive strength training (PST; (2 movement strategy training (MST; or (3 control (“life skills”. PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance >80% did not differ between groups (P=.435. Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.

  13. A 12-week interdisciplinary rehabilitation trial in patients with gliomas – a feasibility study

    DEFF Research Database (Denmark)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek

    2018-01-01

    that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences......PURPOSE: This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. METHOD: We conducted an outpatient two-part rehabilitation intervention......%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive...

  14. Feasibility of feature-based indexing, clustering, and search of clinical trials. A case study of breast cancer trials from ClinicalTrials.gov.

    Science.gov (United States)

    Boland, M R; Miotto, R; Gao, J; Weng, C

    2013-01-01

    When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.

  15. Key feasibility considerations when conducting vaccine clinical trials in Asia–Pacific countries

    Directory of Open Access Journals (Sweden)

    Lansang EZ

    2013-03-01

    Full Text Available Elvira Zenaida Lansang,1 Kenneth Tan,2 Saumya Nayak,1 Ken J Lee,1 Karen Wai1 1Feasibility and Site Identification – Asia, Quintiles East Asia Pte Ltd, Singapore; 2National University of Singapore, Singapore Introduction: Conducting clinical trial feasibility is an important first step in initiating a clinical trial. A robust feasibility process ensures that a realistic capability assessment is made before conducting a trial. A retrospective analysis of vaccine clinical trials was performed to understand changes which could affect feasibility recommendations. Methods: Feasibilities conducted by Quintiles between January 2011 and August 2012 were reviewed. Vaccine studies only involving Asia–Pacific countries were selected, and common study parameters were identified. Information from Quintiles’ database was retrieved to examine changes in parameters over time. Results: A total of six vaccine studies were identified within the 1.7-year period. Two studies were excluded because they did not contain feasibility information or had involved sites that were sponsor selected. Four studies were analyzed. Three cases required healthy volunteers, while one case involved a specific patient population. Age requirement and seasonality of disease mainly influenced recommendations for Study 1. Sponsor’s marketing strategy influenced the recommendations for Study 2. Study 3 showed the effect of a country’s immunization program and reimbursement of vaccines on a study’s success. In contrast to the other studies, Study 4 demonstrated the impact of eligibility criteria in recruitment recommendations for a vaccine trial requiring specific patient pools. Conclusion: Feasibility recommendations for vaccine trials are largely based on (1 eligibility criteria; (2 cultural beliefs; (3 country’s past recruitment performance; (4 use of advertising; (5 site’s access to subject populations; (6 cooperation with local health professionals and government; (7

  16. Report on the feasibility study for improving electric motor service centers in Ghana

    Energy Technology Data Exchange (ETDEWEB)

    Hsu, J.S.; Jallouk, P.A.; Staunton, R.H.

    1999-12-10

    On March 3 and 4, 1998, a visit was made to Oak Ridge National Laboratory (ORNL) by two officials from Ghana: Mr. I.K. Mintah, Acting Executive Director, Technical Wing, Ministry of Mines and Energy (MOME) and Dr. A.K. Ofosu-Ahenkorah, Coordinator, Energy Efficiency and Conservation Program, MOME. As a result of this visit, Dr. John S. Hsu of ORNL was invited by MOME to visit the Republic of Ghana in order to study the feasibility of improving electric motor service centers in Ghana.

  17. Idaho Nuclear Technology and Engineering Center Newly Generated Liquid Waste Demonstration Project Feasibility Study

    Energy Technology Data Exchange (ETDEWEB)

    Herbst, A.K.

    2000-02-01

    A research, development, and demonstration project for the grouting of newly generated liquid waste (NGLW) at the Idaho Nuclear Technology and Engineering Center is considered feasible. NGLW is expected from process equipment waste, decontamination waste, analytical laboratory waste, fuel storage basin waste water, and high-level liquid waste evaporator condensate. The potential grouted waste would be classed as mixed low-level waste, stabilized and immobilized to meet RCRA LDR disposal in a grouting process in the CPP-604 facility, and then transported to the state.

  18. Is total pancreatectomy as feasible, safe, efficacious, and cost-effective as pancreaticoduodenectomy? A single center, prospective, observational study.

    Science.gov (United States)

    Casadei, Riccardo; Ricci, Claudio; Taffurelli, Giovanni; Guariniello, Anna; Di Gioia, Anthony; Di Marco, Mariacristina; Pagano, Nico; Serra, Carla; Calculli, Lucia; Santini, Donatella; Minni, Francesco

    2016-09-01

    Total pancreatectomy is actually considered a viable option in selected patients even if large comparative studies between partial versus total pancreatectomy are not currently available. Our aim was to evaluate whether total pancreatectomy can be considered as feasible, safe, efficacious, and cost-effective as pancreaticoduodenectomy. A single center, prospective, observational trial, regarding postoperative outcomes, long-term results, and cost-effectiveness, in a tertiary referral center was conducted, comparing consecutive patients who underwent elective total pancreatectomy and/or pancreaticoduodenectomy. Seventy-three consecutive elective total pancreatectomies and 184 pancreaticoduodenectomies were compared. There were no significant differences regarding postoperative outcomes and overall survival. The quality of life, evaluated in 119 patients according to the EQ-5D-5L questionnaire, showed that there were no significant differences regarding the five items considered. The mean EQ-5D-5L score was similar in the two procedures (total pancreatectomy = 0.872, range 0.345-1.000; pancreaticoduodenectomy = 0.832, range 0.393-1.000; P = 0.320). The impact of diabetes according to the Problem Areas in Diabetes (PAID) questionnaire did not show any significant differences except for question 13 (total pancreatectomy = 0.60; pancreaticoduodenectomy = 0.19; P = 0.022). The cost-effectiveness analysis suggested that the quality-adjusted life year was not significantly different between the two procedures (total pancreatectomy = 0.910, range 0.345-1.000; pancreaticoduodenectomy = 0.910, range -0.393-1.000; P = 0.320). From this study, it seems reasonable to suggest that total pancreatectomy can be considered as safe, feasible, and efficacious as PD and acceptable in terms of cost-effectiveness.

  19. Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder

    DEFF Research Database (Denmark)

    Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja

    2016-01-01

    and strategies to facilitate study implementation is available in the music therapy literature. Objective: Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety...

  20. Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

    Science.gov (United States)

    Bakitas, Marie; Dionne-Odom, J Nicholas; Pamboukian, Salpy V; Tallaj, Jose; Kvale, Elizabeth; Swetz, Keith M; Frost, Jennifer; Wells, Rachel; Azuero, Andres; Keebler, Konda; Akyar, Imatullah; Ejem, Deborah; Steinhauser, Karen; Smith, Tasha; Durant, Raegan; Kono, Alan T

    2017-08-31

    Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

  1. Feasibility and acceptability of restorative yoga for treatment of hot flushes: a pilot trial.

    Science.gov (United States)

    Cohen, Beth E; Kanaya, Alka M; Macer, Judith L; Shen, Hui; Chang, A Ann; Grady, Deborah

    2007-02-20

    To determine the feasibility and acceptability of a restorative yoga intervention for the treatment of hot flushes in postmenopausal women. A pilot trial in 14 postmenopausal women experiencing > or =4 moderate to severe hot flushes per day or > or =30 moderate to severe hot flushes per week. The intervention consisted of eight restorative yoga poses taught in a 3-h introductory session and 8 weekly 90-min sessions. Feasibility was measured by recruitment rates, subject retention and adherence. Acceptability was assessed by subject interview and questionnaires. Efficacy measures included change in frequency and severity of hot flushes as recorded on a 7-day diary. Recruitment was accomplished as planned. The majority of study subjects (93%) completed the trial. Of those who completed the trial, 92% attended seven or more of the eight yoga sessions. The majority of the subjects were satisfied with the study and 75% continued to practice yoga 3 months after the study. Mean number of hot flushes per week decreased by 30.8% (95% CI 15.6-45.9%) and mean hot flush score decreased 34.2% (95% CI 16.0-52.5%) from baseline to week 8. No adverse events were observed. This pilot trial demonstrates that it is feasible to teach restorative yoga to middle-aged women without prior yoga experience. The high rates of subject retention and satisfaction suggest that yoga is an acceptable intervention in this population. Our results indicate that a larger, randomized controlled trial to explore the efficacy of restorative yoga for treatment of menopausal symptoms would be safe and feasible.

  2. Feasibility of reducing the duration of placebo-controlled trials in schizophrenia research.

    Science.gov (United States)

    McMahon, Robert P; Kelly, Deanna L; Boggs, Douglas L; Li, Lan; Hu, Qiaoyan; Davis, John M; Carpenter, William T

    2008-03-01

    Use of placebo-controlled trials in medical and psychiatric research has been controversial, although a consensus is emerging about conditions under which placebo-controlled trials are ethical. In schizophrenia research, the paradigm of slow onset of antipsychotic effects has led to a model in which placebo-controlled trials of 6-8 weeks duration have been used to demonstrate efficacy. Recent evidence that the largest symptom reductions are typically seen in the first weeks of treatment suggests that shorter placebo-controlled studies to demonstrate antipsychotic efficacy are possible. In a pilot study of the feasibility of shortening placebo-controlled studies, we reanalyzed data from placebo-controlled registry trials of olanzapine and risperidone and found that trials as short as 4 weeks could have similar power to longer term 6-8 week studies, given the estimated time course of treatment effects. Although fuller evaluation is required, the results suggest future antipsychotic trials could be shortened from 6-8 weeks to 3-4 weeks with a relatively low increase in sample size requirements. Shortening placebo-controlled trials would reduce patient burden and ethical objections to prolonged administration of placebo and reduce potential bias due to high dropout rates in longer clinical trials.

  3. Stockbridge Munsee Community Health and Wellness Center and the Mohican Family Center Renewable Energy and Energy Efficiency Feasibility Study

    Energy Technology Data Exchange (ETDEWEB)

    DeRocher, Andy [Stockbridge-Munsee Health and Wellness Center, Bowler, WI (United States); Barrnett, Michael [Stockbridge-Munsee Health and Wellness Center, Bowler, WI (United States)

    2014-03-14

    The results of the Renewable Energy and Energy Efficiency Feasibility Study of Stockbridge Munsee Community’s Health and Wellness Center (HWC) indicate that a variety of renewable energy options and energy conservation measures (ECMs) exist for the facility. A requirement of the Request for Proposal for this study was to assess renewable energy options that could offset 30 to 100 percent of the HWC’s energy use. This study identifies that a geothermal system is the most cost effective renewable energy option available to decrease the HWC’s energy consumption by 30 to 100 percent. Currently the HWC performs in the lowest 8 percent of buildings in its building category, as scored in the EPA portfolio manager benchmarking tool. Multiple ECM opportunities have been identified with paybacks of less than five years to yield an estimated 25-percent decrease in annual energyconsumption. The ECMs within this payback period are estimated to save $26,800 per year with an implementation cost of just $4,650 (0.2 year payback). For the Mohican Family Center document: The results of the Renewable Energy and Energy Efficiency Feasibility Study of Stockbridge Munsee Community’s Mohican Family Center (MFC) indicate that a variety of renewable energy options and energy conservation measures (ECMs) exist for the facility. A requirement of the Request for Proposal for this study was to assess renewable energy options that could offset 30 to 100 percent of the MFC’s energy use. This study identifies that a geothermal system is the most cost effective renewable energy option available to decrease the MFC’s energy consumption by 30 to 100 percent. Currently the MFC performs better than 80 percent of buildings in its building category, as scored in the EPA portfolio manager benchmarking tool. Multiple ECM opportunities have been identified with short term paybacks to yield an estimated 13-percent decrease in energy consumption. The ECMs within this payback period are estimated

  4. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial.

    Science.gov (United States)

    Connolly, Bronwen; Thompson, April; Douiri, Abdel; Moxham, John; Hart, Nicholas

    2015-06-01

    The aim of this study was to investigate feasibility of exercise-based rehabilitation delivered after hospital discharge in patients with intensive care unit-acquired weakness (ICU-AW). Twenty adult patients, mechanically ventilated for more than 48 hours, with ICU-AW diagnosis at ICU discharge were included in a pilot feasibility randomized controlled trial receiving a 16-session exercise-based rehabilitation program. Twenty-one patients without ICU-AW participated in a nested observational cohort study. Feasibility, clinical, and patient-centered outcomes were measured at hospital discharge and at 3 months. Intervention feasibility was demonstrated by high adherence and patient acceptability, and absence of adverse events, but this must be offset by the low proportion of enrolment for those screened. The study was underpowered to detect effectiveness of the intervention. The use of manual muscle testing for the diagnosis of ICU-AW lacked robustness as an eligibility criterion and lacked discrimination for identifying rehabilitation requirements. Process evaluation of the trial identified methodological factors, categorized by "population," "intervention," "control group," and "outcome." Important data detailing the design, conduct, and implementation of a multicenter randomized controlled trial of exercise-based rehabilitation for survivors of critical illness after hospital discharge have been reported. Clinical Trials Identifier NCT00976807. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Final Report Feasibility Study for the California Wave Energy Test Center (CalWavesm)

    Energy Technology Data Exchange (ETDEWEB)

    Blakeslee, Samuel Norman [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States). Inst. for Advanced Technology and Public Policy; Toman, William I. [Protean Wave Energy Ltd., Los Osos, CA (United States); Williams, Richard B. [Leidos Maritime Solutions, Reston, VA (United States); Davy, Douglas M. [CH2M, Sacramento, CA (United States); West, Anna [Kearns and West, Inc., San Francisco, CA (United States); Connet, Randy M. [Omega Power Engineers, LLC, Anaheim, CA (United States); Thompson, Janet [Kearns and West, Inc., San Francisco, CA (United States); Dolan, Dale [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States); Baltimore, Craig [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States); Jacobson, Paul [Electric Power Research Inst. (EPRI), Knoxville, TN (United States); Hagerman, George [Virginia Polytechnic Inst. and State Univ. (Virginia Tech), Blacksburg, VA (United States); Potter, Chris [California Natural Resources Agency, Sacramento, CA (United States); Dooher, Brendan [Pacific Gas and Electric Company, San Francisco, CA (United States); Wendt, Dean [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States); Sheppard, Colin [Humboldt State Univ., Arcata, CA (United States); Harris, Andrew [Humboldt State Univ., Arcata, CA (United States); Lawson, W. Graham [Power Delivery Consultants, Inc., Albany, NY (United States)

    2017-07-31

    The California Wave Energy Test Center (CalWave) Feasibility Study project was funded over multiple phases by the Department of Energy to perform an interdisciplinary feasibility assessment to analyze the engineering, permitting, and stakeholder requirements to establish an open water, fully energetic, grid connected, wave energy test center off the coast of California for the purposes of advancing U.S. wave energy research, development, and testing capabilities. Work under this grant included wave energy resource characterization, grid impact and interconnection requirements, port infrastructure and maritime industry capability/suitability to accommodate the industry at research, demonstration and commercial scale, and macro and micro siting considerations. CalWave Phase I performed a macro-siting and down-selection process focusing on two potential test sites in California: Humboldt Bay and Vandenberg Air Force Base. This work resulted in the Vandenberg Air Force Base site being chosen as the most favorable site based on a peer reviewed criteria matrix. CalWave Phase II focused on four siting location alternatives along the Vandenberg Air Force Base coastline and culminated with a final siting down-selection. Key outcomes from this work include completion of preliminary engineering and systems integration work, a robust turnkey cost estimate, shoreside and subsea hazards assessment, storm wave analysis, lessons learned reports from several maritime disciplines, test center benchmarking as compared to existing international test sites, analysis of existing applicable environmental literature, the completion of a preliminary regulatory, permitting and licensing roadmap, robust interaction and engagement with state and federal regulatory agency personnel and local stakeholders, and the population of a Draft Federal Energy Regulatory Commission (FERC) Preliminary Application Document (PAD). Analysis of existing offshore oil and gas infrastructure was also performed

  6. Art participation for psychosocial wellbeing during stroke rehabilitation: a feasibility randomised controlled trial.

    Science.gov (United States)

    Morris, Jacqui H; Kelly, Chris; Joice, Sara; Kroll, Thilo; Mead, Gillian; Donnan, Peter; Toma, Madalina; Williams, Brian

    2017-08-30

    To examine the feasibility of undertaking a pragmatic single-blind randomised controlled trial (RCT) of a visual arts participation programme to evaluate effects on survivor wellbeing within stroke rehabilitation. Stroke survivors receiving in-patient rehabilitation were randomised to receive eight art participation sessions (n = 41) or usual care (n = 40). Recruitment, retention, preference for art participation and change in selected outcomes were evaluated at end of intervention outcome assessment and three-month follow-up. Of 315 potentially eligible participants 81 (29%) were recruited. 88% (n = 71) completed outcome and 77% (n = 62) follow-up assessments. Of eight intervention group non-completers, six had no preference for art participation. Outcome completion varied between 97% and 77%. Running groups was difficult because of randomisation timing. Effectiveness cannot be determined from this feasibility study but effects sizes suggested art participation may benefit emotional wellbeing, measured on the positive and negative affect schedule, and self-efficacy for Art (d = 0.24-0.42). Undertaking a RCT of art participation within stroke rehabilitation was feasible. Art participation may enhance self-efficacy and positively influence emotional wellbeing. These should be outcomes in a future definitive trial. A cluster RCT would ensure art groups could be reliably convened. Fewer measures, and better retention strategies are required. Implications for Rehabilitation This feasibility randomised controlled trial (RCT) showed that recruiting and retaining stroke survivors in an RCT of a visual arts participation intervention within stroke rehabilitation was feasible. Preference to participate in art activities may influence recruitment and drop-out rates, and should be addressed and evaluated fully. Art participation as part of rehabilitation may improve some aspects of post-stroke wellbeing, including positive affect and self-efficacy for art

  7. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    OpenAIRE

    Andrea Turolla; Omar A. Daud Albasini; Roberto Oboe; Michela Agostini; Paolo Tonin; Stefano Paolucci; Giorgio Sandrini; Annalena Venneri; Lamberto Piron

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop,...

  8. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial.

    Science.gov (United States)

    Powell, John; Newhouse, Nikki; Martin, Angela; Jawad, Sena; Yu, Ly-Mee; Davoudianfar, Mina; Locock, Louise; Ziebland, Sue

    2016-11-11

    The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. Eighty-seven smokers were randomised, 65 completed follow-up (75 %). Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5-213 min). Median logins for both sites was 2 (range 1-20). All participant-reported outcomes were similar between groups. It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated 'dose of information'. ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.

  9. Adolescent Onset of Maternal Substance Abuse: Descriptive Findings from a Feasibility Trial

    OpenAIRE

    Saldana, Lisa; Smith, Dana K.; Weber, Elisa

    2013-01-01

    Although maternal substance abuse in child welfare populations is a well-documented occurrence, little is known about the onset of these behaviors or the substance abuse histories of these mothers. Descriptive data from a small feasibility trial of mothers referred for substance abuse and child neglect suggest adolescent onset of hard substance use. Age of onset was associated with family history of use. The majority of mothers reported polysubstance abuse starting at an early age and quickly...

  10. Computerized Cognitive Behavioral Therapy to Treat Emotional Distress After Stroke: A Feasibility Randomized Controlled Trial

    OpenAIRE

    Simblett, SK; Yates, M; Wagner, AP; Watson, P; Gracey, F; Ring, H; Bateman, Andrew

    2017-01-01

    $\\textbf{Background:}$ Depression and anxiety are common complications following stroke. Symptoms could be treatable with psychological therapy, but there is little research on its efficacy. $\\textbf{Objectives:}$ The aim of this study was to investigate (1) the acceptability and feasibility of computerized cognitive behavioral therapy (cCBT) to treat symptoms of depression and anxiety and (2) a trial design for comparing the efficacy of cCBT compared with an active comparator. $\\te...

  11. Group Metacognitive Therapy vs. Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Randomised Feasibility Trial.

    Science.gov (United States)

    Capobianco, Lora; Reeves, David; Morrison, Anthony P; Wells, Adrian

    2018-01-01

    Two transdiagnostic therapies for treating psychological disorder are Metacognitive Therapy (MCT) and Mindfulness Based Stress Reduction (MBSR). These two approaches have yet to be compared and therefore the current study aimed to evaluate the feasibility of a study of group MCT and MBSR in treating anxiety and depression. A feasibility trial with 40 participants (aged 19-56) was conducted. Patients were randomly assigned to receive either eight weeks of group MCT or MBSR. The primary outcome was feasibility which included recruitment rates, retention and treatment acceptability. The primary symptom outcome was the Hospital Anxiety and Depression Scale (HADS) total score, which provided an overall measure of distress. Both treatments were found to be acceptable with low attrition and similar ratings of acceptability. Changes in outcomes were analyzed based on the intention-to-treat principle using mixed effect models. Preliminary analyses revealed that MCT was more effective in treating anxiety and depression in comparison to MBSR, and in reducing both positive and negative metacognitive beliefs. Reliable improvement rates favoured MCT at post-treatment and 6-month follow up. Both treatments appeared to be feasible and acceptable in treating transdiagnostic samples; however, a larger, definitive trial is required. The limitations and directions for future research are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

    Science.gov (United States)

    Reitsma, Angela; Chu, Rong; Thorpe, Julia; McDonald, Sarah; Thabane, Lehana; Hutton, Eileen

    2014-09-26

    Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. Despite literature that suggests center effect can change the estimate of effect in

  13. Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial.

    Science.gov (United States)

    Roseen, Eric J; Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

    2017-01-01

    Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Single-center 3-arm feasibility randomized controlled trial. Urban academic safety-net hospital. Adult inpatients on the Family Medicine ward. Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting "top box" scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an improved hospital experience, pain management, and connectedness to the massage or music therapist.

  14. Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial

    Science.gov (United States)

    Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

    2017-01-01

    Background Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. Objective To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Design Single-center 3-arm feasibility randomized controlled trial. Setting Urban academic safety-net hospital. Patients Adult inpatients on the Family Medicine ward. Interventions Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Measurements Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting “top box” scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. Results From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Conclusions Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an

  15. Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

    Science.gov (United States)

    Gay, Hawkins C; Baldridge, Abigail S; Huffman, Mark D

    2017-12-01

    Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be

  16. Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Richards Julie

    2011-03-01

    Full Text Available Abstract Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52. This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05 and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004 Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995.

  17. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

    Science.gov (United States)

    Allison, Jeroan J; Nguyen, Hoa L; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Phan, Ngoc T; Vu, Nguyen C; Kim, Minjin; Goldberg, Robert J

    2016-01-14

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel

  18. Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

    Science.gov (United States)

    2010-01-01

    Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will

  19. Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Mechelen Willem

    2010-04-01

    Full Text Available Abstract Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks, associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT, exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement, and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT

  20. Integrative Acupuncture and Spinal Manipulative Therapy Versus Either Alone for Low Back Pain: A Randomized Controlled Trial Feasibility Study.

    Science.gov (United States)

    Kizhakkeveettil, Anupama; Rose, Kevin A; Kadar, Gena E; Hurwitz, Eric L

    The objective of this study was to assess the feasibility of conducting a large-scale randomized controlled trial (RCT) examining whether an integrative care model combining spinal manipulative therapy (SMT) and acupuncture can lead to better outcomes for low back pain (LBP) than either therapy alone. This study was conducted at a complementary and alternative medicine university health center. Participants with acute or chronic LBP were randomized to (1) acupuncture, (2) SMT, or (3) integrative acupuncture and SMT groups. Treatments were provided over 60 days by licensed doctors of chiropractic and acupuncturists. Acupuncture treatments consisted of needling of acupoints combined with electrotherapy, moxibustion, cupping, and Tui Na. SMT used specific contact points on vertebral processes, along with soft tissue therapy and physiotherapy. Primary outcome measures were the Roland-Morris LBP Disability Questionnaire and 0 to 10 Numeric Rating Scale for LBP. Participants in all 3 groups experienced clinically meaningful improvements in the primary outcome measures; however, no between-group differences in outcomes were apparent. This study indicated that it is feasible to conduct an RCT to compare the effectiveness of integrative acupuncture and SMT for LBP to either therapy alone. Future studies should include a larger sample to increase the power for detecting clinically meaningful differences between groups. Copyright © 2017. Published by Elsevier Inc.

  1. Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer.

    Science.gov (United States)

    Lo, Chris; Hales, Sarah; Chiu, Aubrey; Panday, Tania; Malfitano, Carmine; Jung, Judy; Rydall, Anne; Li, Madeline; Nissim, Rinat; Zimmermann, Camilla; Rodin, Gary

    2016-01-19

    Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT). To test trial methodology and assess feasibility of a confirmatory RCT. A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. depressive symptoms (Patient Health Questionnaire-9; PHQ-9). major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting. 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre. Rate of consent was 32%, randomisation 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, OR=1.48, 95% Credible Interval (CRI.95) (0.65, 3.38); MDD, OR=1.56, CRI.95 (0.50, 4.84); attachment anxiety, OR=1.72, CRI.95 (0.73, 4.03); and attachment avoidance, OR=1.58, CRI.95 (0.67, 3.71). There was no support for effects on the seven remaining secondary outcomes. A phase 3 CALM RCT is feasible and should aim to detect effect sizes of d=0.40, with greater attention to issues of compliance and contamination. NCT02353546. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture

    Science.gov (United States)

    Thabane, Lehana; Adachi, Jonathan D.; Ashe, Maureen C.; Bleakney, Robert R.; Braun, E. Anne; Cheung, Angela M.; Fraser, Lisa-Ann; Gibbs, Jenna C.; Hill, Keith D.; Hodsman, Anthony B.; Kendler, David L.; Mittmann, Nicole; Prasad, Sadhana; Scherer, Samuel C.; Wark, John D.; Papaioannou, Alexandra

    2014-01-01

    Background Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral fracture. Objectives This pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial. Design The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups. Setting Five Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services). Participants One hundred sixty women aged ≥65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited. Intervention The Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ≥3 times weekly. Controls will receive equal attention. Measurements Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of

  3. Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture.

    Science.gov (United States)

    Giangregorio, Lora M; Thabane, Lehana; Adachi, Jonathan D; Ashe, Maureen C; Bleakney, Robert R; Braun, E Anne; Cheung, Angela M; Fraser, Lisa-Ann; Gibbs, Jenna C; Hill, Keith D; Hodsman, Anthony B; Kendler, David L; Mittmann, Nicole; Prasad, Sadhana; Scherer, Samuel C; Wark, John D; Papaioannou, Alexandra

    2014-09-01

    Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral fracture. This pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial. The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups. Five Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services). One hundred sixty women aged ≥65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited. The Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ≥3 times weekly. Controls will receive equal attention. Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05. No

  4. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial

    NARCIS (Netherlands)

    Eadie, J.; van de Water, A.T.; Lonsdale, C.; Tully, M.A.; van Mechelen, W.; Boreham, C.A.; Daly, L.; McDonough, S.M.; Hurley, D.A.

    2013-01-01

    Objective: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). Design: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. Setting: Outpatient

  5. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    Science.gov (United States)

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

  6. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

    Directory of Open Access Journals (Sweden)

    McDonald AM

    2011-02-01

    Full Text Available Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons; plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists; three focus groups with anaesthetists (one national, two regional; 58 anaesthetists; two focus groups with members of the patient organisation Arthritis Care (7 participants; telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants; interviews with Chairs of UK ethics committees (6 individuals; postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists; two centre pilot (49 patients assessed. Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions proved easier than the method of anaesthesia (general anaesthesia. General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about

  7. Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

    Science.gov (United States)

    Lyon, Don W; Hopkins, Kristine; Chu, Raymond H; Tamkins, Susanna M; Cotter, Susan A; Melia, B Michele; Holmes, Jonathan M; Repka, Michael X; Wheeler, David T; Sala, Nicholas A; Dumas, Janette; Silbert, David I

    2013-05-01

    We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

  8. Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme.

    Science.gov (United States)

    Day, Crispin; Briskman, Jackie; Crawford, Mike J; Harris, Lucy; McCrone, Paul; McMurran, Mary; Moran, Paul; Morgan, Lou; Scott, Stephen; Stahl, Daniel; Ramchandani, Paul; Weaver, Timothy

    2017-12-01

    The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session). The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers' and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.

  9. Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme

    Directory of Open Access Journals (Sweden)

    Crispin Day

    2017-12-01

    Full Text Available The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session. The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers’ and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.

  10. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

    OpenAIRE

    McCarren M; Twedt EL; Mansuri FM; Nelson PR; Peek BT

    2014-01-01

    Madeline McCarren,1 Elaine L Twedt,1 Faizmohamed M Mansuri,2 Philip R Nelson,3 Brian T Peek3 1Pharmacy Benefits Management Services, Department of Veterans Affairs, Hines, IL, 2Wilkes-Barre VA Medical Center, Wilkes-Barre, PA, 3Charles George VA Medical Center, Asheville, NC, USA Purpose: Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters...

  11. Feasibility of a sedation wake-up trial and spontaneous breathing trial in critically ill trauma patients: a secondary analysis.

    Science.gov (United States)

    Figueroa-Ramos, Milagros I; Arroyo-Novoa, Carmen Mabel; Padilla, Geraldine; Rodríguez-Ortiz, Pablo; Cooper, Bruce A; Puntillo, Kathleen A

    2013-02-01

    To determine the feasibility of conducting a sedation wake-up trial (SWT) plus a spontaneous breathing trial (SBT) in critically ill trauma patients based on the ability to implement the combined intervention; to measure and describe patients' physiological responses; and to maintain patient safety. A secondary analysis of the intervention group from a trial of 20 mechanically ventilated patients receiving SWT plus SBT in a trauma-intensive care unit. Patients passed 67% of the 39 SWTs performed; those who failed presented RASS scores of +1 and +2 (70%), tachycardia (15%) or ventilator asynchrony (15%). Eighteen patients tolerated their first SBT, and after the second SBT, more than half of the patients were discontinued from the mechanical ventilator. A significant increase from the beginning to the end of the SWT was found in heart rate (p=.021), respiratory rate (p=.043) and systolic blood pressure (p=.04). Although these measures increased significantly, their overall mean did not increase by 20%. SWT plus SBT was well tolerated and successfully implemented. Our data showed that it is not necessary to withhold continuous-infusion analgesia during the SWT. Copyright © 2012 Elsevier Ltd. All rights reserved.

  12. Evaluating the feasibility of performing window of opportunity trials in breast cancer.

    Science.gov (United States)

    Arnaout, Angel; Robertson, Susan; Kuchuk, Iryna; Simos, Demetrios; Pond, Gregory R; Addison, Christina L; Namazi, Mehrzad; Clemons, Mark

    2015-01-01

    The waiting period to surgery represents a valuable "window of opportunity" to evaluate novel therapeutic strategies. Interventional studies performed during this period require significant multidisciplinary collaboration to overcome logistical hurdles. We undertook a one-year prospective window of opportunity study to assess feasibility. Eligible newly diagnosed postmenopausal, estrogen receptor positive breast cancer patients awaiting primary surgery received anastrozole daily until surgery. Feasibility was assessed by (a) the proportion of patients who consented and (b) completed the study. Comparison of pre- and poststudy Ki67 labelling index and cleaved caspase 3 scores (CC3) was performed. 22/131 (16.8%) patients were confirmed eligible and 20/22 (91%) patients completed the study. 19/20 (95%) patients agreed to undergo optional additional tissue biopsies. The mean duration of anastrozole use was 24.7 (15-44) days. There were a statistically significant decline in mean Ki67 indices of 48.8% (p window of opportunity trials in breast cancer are a feasible way of assessing the biologic efficacy of different therapies in the presurgical setting. The majority of eligible women were willing to participate including undergoing additional tissue biopsies.

  13. Exercise Programme in Endometrial Cancer; Protocol of the Feasibility and Acceptability Survivorship Trial (EPEC-FAST).

    Science.gov (United States)

    Smits, Anke; Lopes, Alberto; Das, Nagindra; Bekkers, Ruud; Massuger, Leon; Galaal, Khadra

    2015-12-16

    Obesity has been associated with impaired quality of life and poorer outcomes in endometrial cancer survivors. Lifestyle interventions promoting exercise and weight reduction have been proposed for survivorship care. However, studies evaluating exercise programmes for endometrial cancer survivors are lacking. The objective of this study is to evaluate the feasibility of an individualised exercise intervention for endometrial cancer survivors to improve quality of life. This is a feasibility study in which women will undergo a 10-week exercise programme with a personal trainer. The study population comprises women with confirmed diagnosis of endometrial cancer, who have completed surgical treatment with curative intent, and are aged 18 years or older. The study will take place at the Royal Cornwall Hospital Trust, UK. Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes are quality of life, psychological distress, fatigue, pain and complication rates. In addition, the acceptability of the programme will be assessed. Ethical approval was obtained through the Exeter NRES Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses, relevant clinical groups and presented on the Trust's website. NCT02367950; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  14. What Value Can Qualitative Research Add to Quantitative Research Design? An Example From an Adolescent Idiopathic Scoliosis Trial Feasibility Study.

    Science.gov (United States)

    Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E

    2016-08-09

    Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan. © The Author(s) 2016.

  15. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

    DEFF Research Database (Denmark)

    Vester-Andersen, M; Waldau, T; Wetterslev, J

    2015-01-01

    BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care......·16; P = 0·828). Thirty (20·8 per cent) of 144 patients assigned to intermediate care and 37 (26·1 per cent) of 142 assigned to ward care died within the total observation period (hazard ratio 0·78, 95 per cent c.i. 0·48 to 1·26; P = 0·310). CONCLUSION: Postoperative intermediate care had...... ward within 24 h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. RESULTS: In total, 286 patients were included in the modified intention-to-treat analysis. The trial...

  16. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

    Science.gov (United States)

    Menon, Kusum; McNally, Dayre; O'Hearn, Katharine; Acharya, Anand; Wong, Hector R; Lawson, Margaret; Ramsay, Tim; McIntyre, Lauralyn; Gilfoyle, Elaine; Tucci, Marisa; Wensley, David; Gottesman, Ronald; Morrison, Gavin; Choong, Karen

    2017-06-01

    To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. Randomized, double-blind, placebo controlled trial. Seven tertiary level PICUs in Canada. Children newborn to 17 years old inclusive with suspected septic shock. Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

  17. A feasibility and pilot randomized controlled trial of the "Timing it Right Stroke Family Support Program".

    Science.gov (United States)

    Cameron, Jill I; Naglie, Gary; Green, Theresa L; Gignac, Monique A M; Bayley, Mark; Huijbregts, Maria; Silver, Frank L; Czerwonka, Anna

    2015-11-01

    Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data. Multi-site mixed method randomized controlled trial. Acute and community care in three Canadian cities. Caregivers were family members or friends providing care to individuals who experienced their first stroke. The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care. Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver. Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction. Preliminary findings suggest the research design is feasible, caregivers' needs are complex, and the support intervention may enhance caregivers' perceived support and mastery. The intervention will be tested further in a large scale trial. © The Author(s) 2014.

  18. MammaPrint Feasibility in a Large Tertiary Urban Medical Center: An Initial Experience

    Directory of Open Access Journals (Sweden)

    C. Francisco Espinel

    2012-01-01

    Full Text Available Background. The MammaPrint (MP diagnostic assay stratifies breast cancer patients into high- and low-risk groups using mRNA analysis of a 70-gene profile. The assay is validated for assessment of patients with estrogen receptor positive or negative tumors less than 5 cm with 3 or fewer malignant lymph nodes. TargetPrint (TP is an assay for assessing estrogen, progesterone, and HER2-neu receptor status based on mRNA expression. A potential limitation of these assays is that they require an evaluation of fresh tissue samples. There is limited published experience describing MP or TP implementation. Methods. Over 10 months, 4 breast surgeons obtained samples from 54 patients for MP/TP analysis. The samples were analyzed by Agendia Labs. The tumors were independently evaluated for receptor status using immunohistochemistry (IHC. Retrospectively, we identified patients who were assessed by MP/TP during this period. Patients who underwent OncotypeDx evaluation were also identified. Results. Of the 54 patients receiving MP, 4 were found ineligible for MP risk assessment because >3 lymph nodes were found to be malignant. Out of all eligible patients, 14/50 (28% had samples whose quantity of tumor was not sufficient for analysis (QNS. Out of eligible patients with tumors <1 cm, 7/8 (88% had QNS samples. 7/42 with tumors ≥1 cm (17% had QNS samples. Nine patients had discordant receptor results when evaluated by IHC versus. TP. Of patients who also underwent OncotypeDx testing, 6/14 (43% had discordant results with MP. Conclusions. This study indicates that using MP/TP assay is feasible in a tertiary care center but there may be utility in limiting MP testing to patients with tumors between 1 and 5 cm due to high likelihood of uninformative results in subcentimeter tumors. Further study is needed to explore the discordance between oncotype and MP results.

  19. Interactive web-based pulmonary rehabilitation programme: a randomised controlled feasibility trial.

    Science.gov (United States)

    Chaplin, Emma; Hewitt, Stacey; Apps, Lindsay; Bankart, John; Pulikottil-Jacob, Ruth; Boyce, Sally; Morgan, Mike; Williams, Johanna; Singh, Sally

    2017-03-31

    The aim of this study was to determine if an interactive web-based pulmonary rehabilitation (PR) programme is a feasible alternative to conventional PR. Randomised controlled feasibility trial. Participants with a diagnosis of chronic obstructive pulmonary disease were recruited from PR assessments, primary care and community rehabilitation programmes. Patients randomised to conventional rehabilitation started the programme according to the standard care at their referred site on the next available date. 103 patients were recruited to the study and randomised: 52 to conventional rehabilitation (mean (±SD) age 66 (±8) years, Medical Research Council (MRC) 3 (IQR2-4)); 51 to the web arm (mean (±SD) age 66 (±10) years, MRC 3 (IQR2-4)). Participants had to be willing to participate in either arm of the trial, have internet access and be web literate. Patients randomised to the web-based programme worked through the website, exercising and recording their progress as well as reading educational material. Conventional PR consisted of twice weekly, 2 hourly sessions (an hour for exercise training and an hour for education). Recruitment rates, eligibility, patient preference and dropout and completion rates for both programmes were collected. Standard outcomes for a PR assessment including measures of exercise capacity and quality of life questionnaires were also evaluated. A statistically significant improvement (p≤0.01) was observed within each group in the endurance shuttle walk test (WEB: mean change 189±211.1; PR classes: mean change 184.5±247.4 s) and Chronic Respiratory disease Questionnaire-Dyspnoea (CRQ-D; WEB: mean change 0.7±1.2; PR classes: mean change 0.8±1.0). However, there were no significant differences between the groups in any outcome. Dropout rates were higher in the web-based programme (57% vs 23%). An interactive web-based PR programme is feasible and acceptable when compared with conventional PR. Future trials maybe around choice-based PR

  20. Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial.

    LENUS (Irish Health Repository)

    Hurley, Deirdre A

    2010-01-01

    Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population.

  1. Mindfulness-based cognitive therapy for bipolar disorder: a feasibility trial.

    Science.gov (United States)

    Weber, B; Jermann, F; Gex-Fabry, M; Nallet, A; Bondolfi, G; Aubry, J-M

    2010-10-01

    The present open study investigates the feasibility of Mindfulness-based cognitive therapy (MBCT) in groups solely composed of bipolar patients of various subtypes. MBCT has been mostly evaluated with remitted unipolar depressed patients and little is known about this treatment in bipolar disorder. Bipolar outpatients (type I, II and NOS) were included and evaluated for depressive and hypomanic symptoms, as well as mindfulness skills before and after MBCT. Patients' expectations before the program, perceived benefit after completion and frequency of mindfulness practice were also recorded. Of 23 included patients, 15 attended at least four MBCT sessions. Most participants reported having durably, moderately to very much benefited from the program, although mindfulness practice decreased over time. Whereas no significant increase of mindfulness skills was detected during the trial, change of mindfulness skills was significantly associated with change of depressive symptoms between pre- and post-MBCT assessments. MBCT is feasible and well perceived among bipolar patients. Larger and randomized controlled studies are required to further evaluate its efficacy, in particular regarding depressive and (hypo)manic relapse prevention. The mediating role of mindfulness on clinical outcome needs further examination and efforts should be provided to enhance the persistence of meditation practice with time. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  2. Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial

    Directory of Open Access Journals (Sweden)

    de Lange Elly SM

    2011-01-01

    Full Text Available Abstract Background There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery. Methods/Design Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor, quality of life tests and hospital stay. Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm

  3. Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures.

    Science.gov (United States)

    Reynolds, Stacy L; Bryant, Kathleen K; Studnek, Jonathan R; Hogg, Melanie; Dunn, Connell; Templin, Megan A; Moore, Charity G; Young, James R; Walker, Katherine Rivera; Runyon, Michael S

    2017-12-01

    We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine. This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room. Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most

  4. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-10-31

    The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Adolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness. The current trial protocol received a favourable

  5. Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomised controlled trial (RCT).

    Science.gov (United States)

    Walker, Marion F; Thomas, Shirley A; Whitehead, Phillip J; Condon, Laura; Fisher, Rebecca J; Kontou, Eirini; Benford, Penny; Cobley, Christine

    2017-10-22

    Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. ISRCTN

  6. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial.

    Science.gov (United States)

    Simpson, Robert; Mair, Frances S; Mercer, Stewart W

    2017-05-16

    Multiple sclerosis (MS) is a stressful condition. Mental health comorbidity is common. Stress can increase the risk of depression, reduce quality of life (QOL), and possibly exacerbate disease activity in MS. Mindfulness-Based Stress Reduction (MBSR) may help, but has been little studied in MS, particularly among more disabled individuals. The objective of this study was to test the feasibility and likely effectiveness of a standard MBSR course for people with MS. Participant eligibility included: age > 18, any type of MS, an Expanded Disability Status Scale (EDSS) Trial retention and outcome measure completion rates were 90% at post-intervention, and 88% at 3 months. Sixty percent of participants completed the course. Immediately post-MBSR, perceived stress improved with a large effect size (ES 0.93; p < 0.01), compared to very small beneficial effects on QOL (ES 0.17; p = 0.48). Depression (ES 1.35; p < 0.05), positive affect (ES 0.87; p = 0.13), anxiety (ES 0.85; p = 0.05), and self-compassion (ES 0.80; p < 0.01) also improved with large effect sizes. At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were negligible for QOL (ES 0.08; p = 0.71), but were large for mindfulness (ES 1.13; p < 0.001), positive affect (ES 0.90; p = 0.54), self-compassion (ES 0.83; p < 0.05), anxiety (ES 0.82; p = 0.15), and prospective memory (ES 0.81; p < 0.05). Recruitment, retention, and data collection demonstrate that a RCT of MBSR is feasible for people with MS. Trends towards improved outcomes suggest that a larger definitive RCT may be warranted. However

  7. The HAPPY (Healthy and Active Parenting Programmme for early Years feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity

    Directory of Open Access Journals (Sweden)

    Rosemary R. C. McEachan

    2016-03-01

    Full Text Available Abstract Background The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY. Methods A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m2 were recruited between 10–26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59 or usual care (N = 61. Appropriate outcome measures for a full trial were explored, including: infant’s length and weight, woman’s BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content. Results Recruitment targets were met (~20 women/month with a recruitment rate of 30 % of eligible women (120/396. There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1–12. Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of −0.25 standard deviation scores for infant weight at 12 months (95 % CI:

  8. Feasibility and effects of patient-cooperative robot-aided gait training applied in a 4-week pilot trial.

    Science.gov (United States)

    Schück, Alex; Labruyère, Rob; Vallery, Heike; Riener, Robert; Duschau-Wicke, Alexander

    2012-05-31

    way. The limited number of subjects in this pilot trial does not permit valid conclusions on the effect of patient-cooperative robot-aided gait training on walking function. A large, possibly multi-center randomized controlled clinical trial is required to shed more light on this question.

  9. A two year randomized controlled trial of human caloric restriction: feasibility and effects on predictors of health span and longevity

    Science.gov (United States)

    Background: Caloric restriction (CR), energy intake reduced below ad libitum (AL) intake, increases life span in many species. The implications for humans can be clarified by randomized controlled trials of CR. Methods: To determine CRs feasibility, safety, and effects on predictors of longevity, di...

  10. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

    Science.gov (United States)

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2018-01-01

    To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

  11. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial.

    Science.gov (United States)

    Ball, Elizabeth; Newton, Sian; Kahan, Brennan C; Forbes, Gordon; Wright, Neil; Cantalapiedra Calvete, Clara; Gibson, Harry A L; Rogozinska, Ewelina; Rivas, Carol; Taylor, Stephanie J C; Birch, Judy; Dodds, Julie

    2018-01-15

    Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26

  12. Feasibility of intensive parent-child interaction therapy (I-PCIT): Results from an open trial

    Science.gov (United States)

    Graziano, Paulo A.; Bagner, Daniel M.; Slavec, Janine; Hungerford, Gabriela; Kent, Kristine; Babinski, Dara; Derefinko, Karen; Pasalich, Dave

    2014-01-01

    Objective The current pilot study examined the feasibility, acceptability, and initial outcome of an intensive and more condensed version of Parent-Child Interaction Therapy (90 minute sessions for 5 days/week over the course of 2 weeks). Method Using an open trial design, 11 children (M child age = 5.01 years) and their mothers completed a baseline period of 2 weeks, a treatment period of 2 weeks, and a post-treatment evaluation. A follow-up evaluation was also conducted 4 months following treatment completion. Across all assessments, mothers completed measures of child behavior and parenting stress, and observational data was collected during three 5-minute standard situations that vary in the degree of parental control (child-led play, parent-led play, & clean-up). Results All 11 families completed the intervention with extremely high attendance and reported high satisfaction. Results across both mother report and observations showed that: a) externalizing behavior problems were stable during the baseline period; b) treatment was effective in reducing externalizing behavior problems (ds = 1.67-2.50), improving parenting skills (ds = 1.93-6.04), and decreasing parenting stress (d = .91); and c) treatment gains were maintained at follow-up (ds = .53-3.50). Conclusions Overall, preliminary data suggest that a brief and intensive format of a parent-training intervention is a feasible and effective treatment for young children with externalizing behavior problems with clinical implications for improving children's behavioral impairment in a very brief period of time. PMID:26097286

  13. A behavioral economics intervention to increase pertussis vaccination among infant caregivers: A randomized feasibility trial.

    Science.gov (United States)

    Buttenheim, Alison M; Fiks, Alexander G; Burson, Randall C; Wang, Eileen; Coffin, Susan E; Metlay, Joshua P; Feemster, Kristen A

    2016-02-03

    The incidence of pertussis has tripled in the past five years. Infants can be protected by "cocooning," or vaccinating household contacts with the Tdap vaccine. However, Tdap coverage for adult caregivers of infants is low. This study evaluated the feasibility and impact of interventions informed by behavioral economics (retail pharmacy vouchers for Tdap vaccines and a celebrity public service announcement) to increase Tdap vaccination among caregivers of young infants. We conducted a randomized controlled feasibility trial among adults attending newborn well-child visits at an urban Philadelphia pediatric primary care clinic who were not previously vaccinated with Tdap. Participants were randomized to one of four conditions: ($5-off Tdap voucher vs. free voucher)×(watching a 1min video public service announcement (PSA) about Tdap vaccination vs. no PSA). Tdap vaccination was assessed by tracking voucher redemption and following up with participants by phone. Ninety-five adult caregivers of 74 infants were enrolled in the study (mean age 29.3 years; 61% male; relationship to newborn: 54% father, 33% mother, 13% grandparent or other; caregiver insurance status: 35% Medicaid, 34% private insurance, 32% uninsured). Only 1 subject redeemed the retail pharmacy Tdap voucher. Follow-up interviews suggest that, even with the voucher, significant barriers to vaccination remained including: delaying planned vaccination, perceived inconvenient pharmacy locations, and beliefs about pertussis risk and severity. Despite leveraging existing infrastructure for adult vaccination, results suggest that retail pharmacy vouchers delivered during a newborn visit are not an effective strategy for promoting Tdap. Alternate approaches are needed that prioritize convenience and provide an immediate opportunity to vaccinate when motivation is high. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Brain Tumor Trials Collaborative | Center for Cancer Research

    Science.gov (United States)

    Brain Tumor Trials Collaborative In Pursuit of a Cure The mission of the BTTC is to develop and perform state-of-the-art clinical trials in a collaborative and collegial environment, advancing treatments for patients with brain tumors, merging good scientific method with concern for patient well-being and outcome.

  15. COP - Pet Owners - Open Clinical Trials | Center for Cancer Research

    Science.gov (United States)

    Current Open Clinical Trials If you are interested in learning more about the eligibility requirements for any of open studies listed below, please contact the nearest participating University or Christina Mazcko. To search studies being conducted by other groups please visit Vet Cancer Trials. This will allow you to search by location and tumor type.

  16. Economic feasibility of converting center pivot irrigation to subsurface drip irrigation

    Science.gov (United States)

    Advancements in irrigation technology have increased water use efficiency. However, producers can be reluctant to convert to a more efficient irrigation system when the initial investment costs are high. This study examines the economic feasibility of replacing low energy precision application (LEPA...

  17. Feasibility of an incentive scheme to promote active travel to school: a pilot cluster randomised trial.

    Science.gov (United States)

    Ginja, Samuel; Arnott, Bronia; Araujo-Soares, Vera; Namdeo, Anil; McColl, Elaine

    2017-01-01

    In Great Britain, 19% of trips to primary school within 1 mile, and 62% within 1-2 miles, are by car. Active travel to school (ATS) offers a potential source of moderate-to-vigorous physical activity (MVPA). This study tested the feasibility of an intervention to promote ATS in 9-10 year olds and associated trial procedures. A parallel cluster randomised pilot trial was conducted over 9 weeks in two schools from a low-income area in northeast England. Measures included daily parental ATS reports (optionally by SMS) and child ATS reports, as well as accelerometry (ActiGraph GT3X+). At baseline, all children were asked to wear the accelerometer for the same week; in the post-randomisation phase, small subsamples were monitored each week. In the 2 weeks when a child wore the accelerometer, parents also reported the start and finish times of the journey to school. The intervention consisted of a lottery-based incentive scheme; every ATS day reported by the parent, whether by paper or SMS, corresponded to one ticket entered into a weekly £5 voucher draw. Before each draw session, the researcher prepared the tickets and placed them into an opaque bag, from which one was randomly picked by the teacher at the draw session. Four schools replied positively (3.3%, N = 123) and 29 participants were recruited in the two schools selected (33.0%, N = 88). Participant retention was 93.1%. Most materials were returned on time: accelerometers (81.9%), parental reports (82.1%) and child reports (97.9%). Draw sessions lasted on average 15.9 min (IQR 10-20) and overall session attendance was 94.5%. Parent-child report agreement regarding ATS was moderate (k = 0.53, CI 95% 0.45; 0.60). Differences in minutes of accelerometer-assessed MVPA between parent-reported ATS and non-ATS trips were assessed during two timeframes: during the journey to school based on the times reported by the parent (U = 390.5, p trips were also significant for each of the timeframes considered

  18. Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

    Science.gov (United States)

    2016-09-01

    Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  19. Internet-delivered cognitive behavioural therapy for depression: a feasibility open trial for older adults.

    Science.gov (United States)

    Dear, Blake F; Zou, Judy; Titov, Nickolai; Lorian, Carolyn; Johnston, Luke; Spence, Jay; Anderson, Tracy; Sachdev, Perminder; Brodaty, Henry; Knight, Robert G

    2013-02-01

    Depression is an important health issue amongst older adults. Internet-delivered cognitive behaviour therapy (iCBT) may help to reduce barriers and improve access to treatment, but few studies have examined its use with older adults. The present study evaluated the efficacy, acceptability and feasibility of a brief iCBT program, the Managing Your Mood Program, to treat depression amongst adults aged 60 years and older. Using an open trial design, 20 participants with elevated symptoms of depression (Patient Health Questionnaire 9-item (PHQ-9) total scores ≥ 10) received access to five educational lessons and homework summaries, additional resources, a moderated discussion forum and weekly telephone or email contact from a clinical psychologist. Eighty percent of the sample met diagnostic criteria for a major depressive episode at pre-treatment. Completion rates and response rates were high, with 16/20 participants completing the five lessons within the 8 weeks, and post-treatment and 3-month follow-up data being collected from 17/20 participants. Participants improved significantly on the PHQ-9 and Geriatric Depression Scale (GDS), with large within-group effect sizes (Cohen's d) at follow-up of 1.41 and 2.04, respectively. The clinician spent a mean time of 73.75 minutes (SD = 36.10 minutes) contacting participants within the trial and the program was rated as highly acceptable by participants. The results are encouraging and support the potential value of iCBT in the treatment of depressive symptoms amongst older adults.

  20. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol.

    Science.gov (United States)

    Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max

    2012-03-22

    With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a

  1. A randomized, controlled animal trial demonstrating the feasibility and safety of the Magellan™ endovascular robotic system.

    Science.gov (United States)

    Duran, Cassidy; Lumsden, Alan B; Bismuth, Jean

    2014-02-01

    The success of remotely steerable catheters designed for cardiac ablation procedures in the peripheral vasculature (in the laboratory and in highly select live cases) has led to the development of a vascular robotic system designed specifically for use in the arterial and venous systems. Limited bench-top and animal testing has been successful, but no randomized, controlled study of the system's safety has been performed. In a 3-phase study, we performed a randomized, controlled trial comparing standard manual catheterization and balloon angioplasty of visceral, renal, and contralateral lower extremity vessels in a porcine model. We also demonstrated feasibility of standard device deployment through the system. There was 100% technical success in test (robotic) and control (manual) arm cannulation and balloon angioplasty of all target vessels, without complications. Pathologic analysis at 7 days revealed significantly fewer traumatic lesions in the test animal arm as compared with the control arm (P robotic catheters are at least as safe as manual catheter techniques, and may prove less traumatic to peripheral vessels. Standard devices can be deployed through the system, and the stability of the platform may aid in ease of device delivery in difficult vascular segments. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Science.gov (United States)

    Daud Albasini, Omar A.; Oboe, Roberto; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain. PMID:24319496

  3. Guided imagery targeting exercise, food cravings, and stress: a multi-modal randomized feasibility trial.

    Science.gov (United States)

    Giacobbi, Peter; Long, Dustin; Nolan, Richard; Shawley, Samantha; Johnson, Kelsey; Misra, Ranjita

    2017-08-01

    The purpose of this randomized wait-list controlled trial was to test the feasibility and preliminary efficacy of a guided imagery based multi-behavior intervention intended to address psychological stress, food cravings, and physical activity. Personalized guided imagery scripts were created and participants were instructed to practice guided imagery every day for 35 consecutive days. Of 48 women who enrolled, we report comparisons between 16 randomized to treatment with 19 who were wait-listed (overall Mage = 45.50; Mbodymassindex = 31.43). Study completers reported 89% compliance with practicing guided imagery during the intervention. A significant time-by-group interaction was observed with reductions in food cravings and increases in physical activity compared with wait-list controls. Telephone-based multi-behavior interventions that utilize guided imagery to address food cravings and exercise behavior appear to be acceptable for overweight and obese women. Future phone-based guided imagery research testing this skill to address multiple health behaviors is justified.

  4. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Directory of Open Access Journals (Sweden)

    Andrea Turolla

    2013-01-01

    Full Text Available Background. Haptic robots allow the exploitation of known motorlearning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  5. Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

    Science.gov (United States)

    Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  6. TummyTrials: A Feasibility Study of Using Self-Experimentation to Detect Individualized Food Triggers.

    Science.gov (United States)

    Karkar, Ravi; Schroeder, Jessica; Epstein, Daniel A; Pina, Laura R; Scofield, Jeffrey; Fogarty, James; Kientz, Julie A; Munson, Sean A; Vilardaga, Roger; Zia, Jasmine

    2017-05-02

    Diagnostic self-tracking, the recording of personal information to diagnose or manage a health condition, is a common practice, especially for people with chronic conditions. Unfortunately, many who attempt diagnostic self-tracking have trouble accomplishing their goals. People often lack knowledge and skills needed to design and conduct scientifically rigorous experiments, and current tools provide little support. To address these shortcomings and explore opportunities for diagnostic self-tracking, we designed, developed, and evaluated a mobile app that applies a self-experimentation framework to support patients suffering from irritable bowel syndrome (IBS) in identifying their personal food triggers. TummyTrials aids a person in designing, executing, and analyzing self-experiments to evaluate whether a specific food triggers their symptoms. We examined the feasibility of this approach in a field study with 15 IBS patients, finding that participants could use the tool to reliably undergo a self-experiment. However, we also discovered an underlying tension between scientific validity and the lived experience of self-experimentation. We discuss challenges of applying clinical research methods in everyday life, motivating a need for the design of self-experimentation systems to balance rigor with the uncertainties of everyday life.

  7. Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial.

    Science.gov (United States)

    Lingford-Hughes, Anne; Patel, Yash; Bowden-Jones, Owen; Crawford, Mike J; Dargan, Paul I; Gordon, Fabiana; Parrott, Steve; Weaver, Tim; Wood, David M

    2016-09-27

    GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) and 1,4-butanediol (1,4-BD) are central nervous system depressants whose street names include 'G' and 'liquid ecstasy'. They are used recreationally predominately for their stimulant and pro-sexual effects or for sedation to help with sleep and/or to 'come down' after using stimulant recreational drugs. Although overall population prevalence is low (0.1 %), in some groups such as men who have sex with men, GHB/GBL use may reach 20 %. GHB/GBL dependence may be associated with severe withdrawal with individuals presenting either acutely to emergency departments or to addiction services for support. Benzodiazepines are currently prescribed for GHB/GBL detoxification but do not prevent all complications, such as behavioural disinhibition, that may require hospitalisation or admission to a high dependency/intensive care unit. The GABAB receptor mediates most effects of GHB/GBL and the GABAB agonist, baclofen, has shown promise as an adjunct to benzodiazepines in reducing withdrawal severity when prescribed both during withdrawal and as a 2-day 'preload' prior to detoxification. The key aim of this feasibility study is provide information about recruitment and characteristics of the proposed outcome measure (symptom severity, complications including delirium and treatment escalation) to inform an application for a definitive randomised placebo controlled trial to determine the role of baclofen in the management of GHB/GBL withdrawal and whether starting baclofen 2 days earlier improves outcomes further. This is a prospective, randomised, double-blind, placebo-controlled feasibility study that will recruit participants (aged over 18 years) who are GHB/GBL-dependent and wish to undergo planned GHB/GBL detoxification or are at risk of acute withdrawal and are inpatients requiring unplanned withdrawal. We aim to recruit 88 participants: 28 unplanned inpatients and 60 planned outpatients. During

  8. A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents.

    Science.gov (United States)

    Stow, Ruth; Ives, Natalie; Smith, Christina; Rick, Caroline; Rushton, Alison

    2015-09-28

    Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken. Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months. All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC

  9. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Directory of Open Access Journals (Sweden)

    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  10. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Science.gov (United States)

    2012-01-01

    Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year [1], coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious

  11. Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.

    Science.gov (United States)

    Gágyor, Ildikó; Bleidorn, Jutta; Wegscheider, Karl; Hummers-Pradier, Eva; Kochen, Michael M

    2011-04-01

    Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices. This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety. The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial. To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial

  12. A low cost virtual reality system for home based rehabilitation of the arm following stroke: a randomised controlled feasibility trial.

    Science.gov (United States)

    Standen, P J; Threapleton, K; Richardson, A; Connell, L; Brown, D J; Battersby, S; Platts, F; Burton, A

    2017-03-01

    To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke. Two group feasibility randomised controlled trial of intervention versus usual care. Patients' homes. Patients aged 18 or over, with residual arm dysfunction following stroke and no longer receiving any other intensive rehabilitation. Eight weeks' use of a low cost home-based virtual reality system employing infra-red capture to translate the position of the hand into game play or usual care. The primary objective was to collect information on the feasibility of a trial, including recruitment, collection of outcome measures and staff support required. Patients were assessed at three time points using the Wolf Motor Function Test, Nine-Hole Peg Test, Motor Activity Log and Nottingham Extended Activities of Daily Living. Over 15 months only 47 people were referred to the team. Twenty seven were randomised and 18 (67%) of those completed final outcome measures. Sample size calculation based on data from the Wolf Motor Function Test indicated a requirement for 38 per group. There was a significantly greater change from baseline in the intervention group on midpoint Wolf Grip strength and two subscales of the final Motor Activity Log. Training in the use of the equipment took a median of 230 minutes per patient. To achieve the required sample size, a definitive home-based trial would require additional strategies to boost recruitment rates and adequate resources for patient support.

  13. The Feasibility and Effects of Acupuncture on Quality of Life Scores During Chemotherapy in Ovarian Cancer: Results from a Pilot, Randomized Sham-Controlled Trial

    Science.gov (United States)

    Matulonis, Ursula A.; Dunn, Julie E.; Lee, Hang; Doherty-Gilman, Anne; Dean-Clower, Elizabeth; Goodman, Annekathryn; Davis, Roger B.; Buring, Julie; Wayne, Peter; Rosenthal, David S.; Penson, Richard T.

    2012-01-01

    Abstract Background Within a pilot trial regarding chemotherapy-induced neutropenia, the secondary aim of the main study was explored. This involved measuring the effects—as shown on two key measurement scales reflecting quality of life (QoL)—of verum versus sham acupuncture on patients with ovarian cancer during chemotherapy. Objective The aim of this substudy was to determine the feasibility of determining the effects of verum acupuncture versus sham acupuncture on QoL in patients with ovarian cancer during chemotherapy. Design This was a randomized, sham-controlled trial. Setting The trial was conducted at two cancer centers. Patients Patients with ovarian cancer (N=21) who were receiving chemotherapy—primarily intravenous carboplatin and paclitaxel—participated in this substudy. Intervention The participants were given either active or sham acupuncture 1 week prior to cycle 2 of chemotherapy. There were ten sessions of acupuncture, with manual and electro-stimulation over a 4-week period. Main Outcome Measures The European Organization for Research and Treatment of Cancer-Quality-of-Life Questionnaire-Core 30 Item (EORTC-QLQ-C30) and the Quality of Life Questionnaire–Ovarian Cancer Module-28 Item (QLQ-OV28) were administered to the patients at baseline and at the end of their acupuncture sessions. Results Of the original 21, 15 patients (71%) completed the study, and 93% of them completed the questionnaires. The EORTC-QLQ-C30 subscores were improved in the acupuncture arm, including the mean scores of social function (SF), pain, and insomnia (p=0.05). However, after adjusting for baseline differences, only the SF score was significantly higher in the active acupuncture arm, compared with the sham acupuncture arm (p=0.03). Conclusions It appears feasible to conduct a randomized sham-controlled acupuncture trial measuring QoL for patients with ovarian cancer who are undergoing chemotherapy. Acupuncture may have a role in improving QoL during

  14. Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Trevelyan, Esmé G; Turner, Warren A; Robinson, Nicola

    2015-04-12

    Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain. An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback. Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible

  15. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kvillemo, Pia; Brandberg, Yvonne; Bränström, Richard

    2016-07-22

    Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was

  16. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials

    NARCIS (Netherlands)

    Gillies, K.; Elwyn, G.; Cook, J

    2014-01-01

    BACKGROUND: Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of

  17. Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

    2015-12-01

    Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p smoke-free with increasing intensity of the intervention (control children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. A Feasibility Trial of Home Administration of Intranasal Vaccine by Parents to Eligible Children.

    Science.gov (United States)

    Jhaveri, Ravi; Allyne, Kristin

    2017-01-01

    Intranasal vaccines are being developed for protection against many different infectious agents. The currently available intranasal live attenuated influenza vaccine (LAIV) is only approved for administration by medical personnel. We conducted a pilot study to investigate the feasibility of training parents to give LAIV to their own children. Subjects were recruited from several sources: a university-based outpatient clinic, university employee e-mail announcement, and direct referrals from study subjects. After confirming eligibility to receive LAIV, consented parents were trained by viewing a video with the study staff. LAIV was provided in a cooler with instructions to vaccinate within 24 hours. Telephone follow-up was conducted to confirm proper administration and to assess parental attitudes about home administration. At season's end, immunization registry and hospital records were reviewed to confirm no additional doses were given. Twenty-seven families with 41 children were enrolled. All participants successfully administered LAIV to their children, and all preferred or strongly preferred home administration to an office visit for getting vaccinated. Two families stated that without this option they would not have otherwise vaccinated their children. Adverse events were minor. All patients had their state vaccine registries accurately updated and none received duplicate doses. Upon review, no reimbursement was received for vaccination. Home administration of intranasal LAIV was successful and well received. This option could be used in the future for LAIV or other intranasal vaccines as a way to increase vaccination rates and convenience for parents. ClinicalTrials.gov identifier: NCT01938170. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  19. A feasibility study of soft embalmed human breast tissue for preclinical trials of HIFU- preliminary results

    Science.gov (United States)

    Joy, Joyce; Yang, Yang; Purdie, Colin; Eisma, Roos; Melzer, Andreas; Cochran, Sandy; Vinnicombe, Sarah

    2017-03-01

    Breast cancer is the commonest cancer in women in the UK, accounting for 30% of all new cancers in women, with an estimated 49,500 new cases in 20101. With the widespread negative publicity around over-diagnosis and over-treatment of low risk breast cancers, interest in the application of non-invasive treatments such as magnetic resonance imaging (MRI) guided high intensity focused ultrasound (HIFU) has increased. Development has begun of novel US transducers and platforms specifically designed for use with breast lesions, so as to improve the range of breast lesions that can be safely treated. However, before such transducers can be evaluated in patients in clinical trials, there is a need to establish their efficacy. A particular issue is the accuracy of temperature monitoring of FUS with MRI in the breast, since the presence of large amounts of surrounding fat can hinder temperature measurement. An appropriate anatomical model that imposes similar physical constraints to the breast and that responds to FUS in the same way would be extremely advantageous. The aim of this feasibility study is to explore the use of Thiel embalmed cadaveric tissue for these purposes. We report here the early results of laboratory-based experiments sonicating dissected breast samples from a Thiel embalmed soft human cadaver with high body mass index (BMI). A specially developed MRI compatible chamber and sample holder was developed to secure the sample and ensure reproducible sonications at the transducer focus. The efficacy of sonication was first studied with chicken breast and porcine tissue. The experiments were then repeated with the dissected fatty breast tissue samples from the soft-embalmed human cadavers. The sonicated Thiel breast tissue was examined histopathologically, which confirmed the absence of any discrete lesion. To investigate further, fresh chicken breast tissue was embalmed and the embalmed tissue was sonicated with the same parameters. The results confirmed the

  20. The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome.

    Science.gov (United States)

    Palmer, Shea; Cramp, Fiona; Clark, Emma; Lewis, Rachel; Brookes, Sara; Hollingworth, William; Welton, Nicky; Thom, Howard; Terry, Rohini; Rimes, Katharine A; Horwood, Jeremy

    2016-06-01

    Joint hypermobility syndrome (JHS) is a heritable disorder associated with laxity and pain in multiple joints. Physiotherapy is the mainstay of treatment, but there is little research investigating its clinical effectiveness. To develop a comprehensive physiotherapy intervention for adults with JHS; to pilot the intervention; and to conduct a pilot randomised controlled trial (RCT) to determine the feasibility of conducting a future definitive RCT. Patients' and health professionals' perspectives on physiotherapy for JHS were explored in focus groups (stage 1). A working group of patient research partners, clinicians and researchers used this information to develop the physiotherapy intervention. This was piloted and refined on the basis of patients' and physiotherapists' feedback (stage 2). A parallel two-arm pilot RCT compared 'advice' with 'advice and physiotherapy' (stage 3). Random allocation was via an automated randomisation service, devised specifically for the study. Owing to the nature of the interventions, it was not possible to blind clinicians or patients to treatment allocation. Stage 1 - focus groups were conducted in four UK locations. Stages 2 and 3 - piloting of the intervention and the pilot RCT were conducted in two UK secondary care NHS trusts. Stage 1 - patient focus group participants (n = 25, three men) were aged > 18 years, had a JHS diagnosis and had received physiotherapy within the preceding 12 months. The health professional focus group participants (n = 16, three men; 14 physiotherapists, two podiatrists) had experience of managing JHS. Stage 2 - patient participants (n = 8) were aged > 18 years, had a JHS diagnosis and no other musculoskeletal conditions causing pain. Stage 3 - patient participants for the pilot RCT (n = 29) were as for stage 2 but the lower age limit was 16 years. For the pilot RCT (stage 3) the advice intervention was a one-off session, supplemented by advice booklets. All participants could ask

  1. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

    Science.gov (United States)

    Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

    2014-07-30

    Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN

  2. Final Report Feasibility Study for the California Wave Energy Test Center (CalWavesm) - Volume #2 - Appendices #16-17

    Energy Technology Data Exchange (ETDEWEB)

    Dooher, Brendan [Pacific Gas and Electric Company, San Ramon, CA (United States). Applied Technical Services; Toman, William I. [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States). Inst. of Advanced Technology and Public Policy; Davy, Doug M. [CH2M Hill Engineers, Inc., Sacramento, CA (United States); Blakslee, Samuel N. [California Polytechnic State Univ. (CalPoly), San Luis Obispo, CA (United States)

    2017-07-31

    The California Wave Energy Test Center (CalWave) Feasibility Study project was funded over multiple phases by the Department of Energy to perform an interdisciplinary feasibility assessment to analyze the engineering, permitting, and stakeholder requirements to establish an open water, fully energetic, grid connected, wave energy test center off the coast of California for the purposes of advancing U.S. wave energy research, development, and testing capabilities. Work under this grant included wave energy resource characterization, grid impact and interconnection requirements, port infrastructure and maritime industry capability/suitability to accommodate the industry at research, demonstration and commercial scale, and macro and micro siting considerations. CalWave Phase I performed a macro-siting and down-selection process focusing on two potential test sites in California: Humboldt Bay and Vandenberg Air Force Base. This work resulted in the Vandenberg Air Force Base site being chosen as the most favorable site based on a peer reviewed criteria matrix. CalWave Phase II focused on four siting location alternatives along the Vandenberg Air Force Base coastline and culminated with a final siting down-selection. Key outcomes from this work include completion of preliminary engineering and systems integration work, a robust turnkey cost estimate, shoreside and subsea hazards assessment, storm wave analysis, lessons learned reports from several maritime disciplines, test center benchmarking as compared to existing international test sites, analysis of existing applicable environmental literature, the completion of a preliminary regulatory, permitting and licensing roadmap, robust interaction and engagement with state and federal regulatory agency personnel and local stakeholders, and the population of a Draft Federal Energy Regulatory Commission (FERC) Preliminary Application Document (PAD). Analysis of existing offshore oil and gas infrastructure was also performed

  3. Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing.

    Science.gov (United States)

    Eckermann, Simon; Willan, Andrew R

    2013-05-01

    Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of their performance over time. Such arrangements rely on prospective information regarding the incremental net benefit of the new technology, and its use in practice. However, once the new technology has been adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of positive while uncertain incremental health and net monetary benefit. Informed patients in these cases would likely be reluctant to participate in a trial, preferring instead to receive the new technology with certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials. Consequently, efficiently designed global trials better align the interests of decision makers and manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local trials, up until the point that current evidence is globally sufficient.

  4. Randomized Controlled Trial Assessing the Feasibility of Shortened Fasts in Intubated ICU Patients Undergoing Tracheotomy.

    Science.gov (United States)

    Gonik, Nathan; Tassler, Andrew; Ow, Thomas J; Smith, Richard V; Shuaib, Stefan; Cohen, Hillel W; Sarta, Catherine; Schiff, Bradley A

    2016-01-01

    American Society of Anesthesiology guidelines recommend preoperative fasts of 6 hours after light snacks and 8 hours after large meals. These guidelines were designed for healthy patients undergoing elective procedures but are often applied to intubated intensive care unit (ICU) patients. ICU patients undergoing routine procedures may be subjected to unnecessary prolonged fasts. This study tests whether shorter fasts allow for better nutrition delivery and patient outcomes without increasing the risk. Randomized blinded controlled trial. Tertiary academic medical center. ICU patients undergoing bedside tracheotomy. Intubated ICU patients who were receiving enteral feeding and for whom bedside tracheotomy was indicated were enrolled prospectively and randomly allocated to 2 parallel preoperative fasting regimens: a 6-hour fast (control) and a 45-minute fast (intervention). Patients were assessed for aspiration, caloric delivery, metabolic markers, and infectious and noninfectious complications. Twenty-four patients were enrolled and randomized. There were no complications related to the procedure. There were no cases of intraoperative aspiration identified. There was a single postoperative pneumonia in the control group. Median (interquartile range) length of fast and caloric delivery were significantly different between the control group and the shortened fast group: 22 hours (18, 34) vs 14 hours (5, 25; P < .001) and 429 kcal (57, 1125) vs 1050 kcal (825, 1410; P = .01), respectively. Shortening preoperative fasts in intubated ICU patients allowed for better caloric delivery in the preoperative period. © American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.

  5. Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial.

    Science.gov (United States)

    Treweek, Shaun; Pearson, Ewan; Smith, Natalie; Neville, Ron; Sargeant, Paul; Boswell, Brian; Sullivan, Frank

    2010-01-01

    Recruitment to trials in primary care is often difficult, particularly when practice staff need to identify study participants with acute conditions during consultations. The Scottish Acute Recruitment Management Application (SARMA) system is linked to general practice electronic medical record (EMR) systems and is designed to provide recruitment support to multi-centre trials by screening patients against trial inclusion criteria and alerting practice staff if the patient appears eligible. For patients willing to learn more about the trial, the software allows practice staff to send the patient's contact details to the research team by text message. To evaluate the ability of the software to support trial recruitment. Software evaluation embedded in a randomised controlled trial. Five general practices in Tayside and Fife, Scotland. SARMA was used to support recruitment to a feasibility trial (the Response to Oral Agents in Diabetes, or ROAD trial) looking at users of oral therapy in diabetes. The technical performance of the software and its utility as a recruitment tool were evaluated. The software was successfully installed at four of the five general practices and recruited 11 of the 29 participants for ROAD (other methods were letter and direct invitation by a practice nurse) and had a recruitment return of 35% (11 of 31 texts sent led to a recruitment). Screen failures were relatively low (7 of 31 referred). Practice staff members were positive about the system. An automated recruitment tool can support primary care trials in Scotland and has the potential to support recruitment in other jurisdictions. It offers a low-cost supplement to other trial recruitment methods and is likely to have a much lower screen failure rate than blanket approaches such as mailshots and newspaper campaigns.

  6. Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa

    Directory of Open Access Journals (Sweden)

    Lucy Chimoyi

    2017-07-01

    Full Text Available Abstract Background Developing an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine. Methods One hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (at 12 months to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed. Results Men were a median 25 years old (inter-quartile range = 23–29, 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm (405/450 and 88% (396/450 in the delayed arm (P = 0.338. Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group (P = 0.001. Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group (P = 0.080. Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine (98%, the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine (81% and altruism (75%, rather than by reimbursement incentives (2%. Conclusions Recruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in

  7. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study.

    Science.gov (United States)

    Gueli Alletti, Salvatore; Bottoni, Carolina; Fanfani, Francesco; Gallotta, Valerio; Chiantera, Vito; Costantini, Barbara; Cosentino, Francesco; Ercoli, Alfredo; Scambia, Giovanni; Fagotti, Anna

    2016-04-01

    Laparoscopy has acquired an increasing role in the management of ovarian cancer. Laparoscopic cytoreduction could represent a new frontier for selected patients after neoadjuvant chemotherapy (NACT). We sought to assess feasibility and early complication rate of minimally invasive (MI) interval debulking surgery (IDS) in stage III-IV epithelial ovarian cancer (EOC) patients after NACT. This is a phase II multicentric study in advanced EOC cases with clinical complete response after NACT, according to Gynecologic Cancer Intergroup and Response Evaluation Criteria In Solid Tumors criteria. Institutional review board approval was obtained and all patients signed written informed consent to be included in the protocol. The study was registered in clinicaltrials.gov (NCT02324595) and was named "MISSION" trial. For patients meeting inclusion criteria, surgical procedures started with diagnostic laparoscopy to confirm preoperative findings and assess surgical complexity. MI-IDS included hysterectomy, bilateral salpingo-oophorectomy, appendectomy, omentectomy, peritonectomy, and bowel resection. Pelvic and/or aortic lymphadenectomy was not considered as standard procedure in these cases. Intraoperative and postoperative outcomes, time to restart chemotherapy, survival rate, and quality of life data were registered. From December 2013 through February 2015, of 184 advanced EOC patients considered eligible for IDS, 52 (28.2%) met inclusion criteria and were enrolled in the study. For 22 (12%) of them, standard laparotomic approach was preferred because of intraoperative surgeon evaluation. Thirty (16.3%) patients received the planned treatment of MI-IDS. Median age was 61 (range 39-81) years and median body mass index was 24 (range 20-31) kg/m(2). Median numbers of NACT cycles was 4 (range 3-7). Median operative time was 285 (range 124-418) minutes and median estimated blood loss was 100 (range 50-200) mL. Surgical procedures included 28 (93.3%) hysterectomy and bilateral

  8. Comparing individual and group intervention for psychological adjustment in people with multiple sclerosis: a feasibility randomised controlled trial.

    Science.gov (United States)

    das Nair, Roshan; Kontou, Eirini; Smale, Kathryn; Barker, Alex; Lincoln, Nadina B

    2016-12-01

    To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. Feasibility randomised controlled trial. Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. People with multiple sclerosis. Adjustment to multiple sclerosis in individual or group delivery format. Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual (n=11) or group (n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions. © The Author(s) 2015.

  9. Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial.

    Science.gov (United States)

    Brünahl, Christian A; Klotz, Susanne G R; Dybowski, Christoph; Riegel, Björn; Gregorzik, Sonja; Tripp, Dean A; Ketels, Gesche; Löwe, Bernd

    2018-01-09

    Chronic pelvic pain syndrome (CPPS) is a pain condition perceived in the pelvic area for at least 6 months. While evidence of the aetiology and maintenance of CPPS is still unclear and therapy options are rare, there is preliminary evidence for the efficacy of cognitive behavioural therapy and physiotherapy. However, an integrated treatment has not yet been studied. The primary aim of this study is therefore to test the feasibility of combined psychotherapy and physiotherapy for female and male patients with CPPS. The secondary aim is to explore changes in patient-relevant and economic outcomes compared to a control group. A feasibility study with a crossover design based on the principles of a 'cohort multiple randomized controlled trial' will be conducted to test a combined therapy for patients with CPPS. The study will consist of two consecutive treatment modules (cognitive behavioural group psychotherapy and physiotherapy as individual and group sessions), which will be applied in varying order. The modules will consist of nine weekly sessions with a 4-week break between the modules. The control group will undergo treatment as usual. Study subjects will be recruited from the interdisciplinary outpatient clinic for CPPS at the University Medical Center Hamburg-Eppendorf. Thirty-six patients will be assigned to the intervention, and 18 patients will be assigned to the control group. The treatment groups will be gender homogeneous. Feasibility as the primary outcome will be analysed in terms of the demand, acceptability, and practicality. Secondary study outcomes will be measured using validated self-rating-scales and physical examinations. To the best of our knowledge, this study is the first to investigate the feasibility of combined psychotherapy and physiotherapy for patients with CPPS. In addition to testing feasibility, the results can be used for the preliminary estimation of therapeutic effects. The results from this study will be used to generate an

  10. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  11. Bristol Girls Dance Project Feasibility Trial: outcome and process evaluation results

    Directory of Open Access Journals (Sweden)

    Jago Russell

    2012-07-01

    Full Text Available Abstract Background Many adolescent girls do not engage in sufficient physical activity (PA. This study examined the feasibility of conducting a cluster randomized controlled trial (RCT to evaluate an after-school dance program to increase PA among 11–12 year old girls in Bristol, UK. Methods Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0, during the last week of the dance program (time 1 and 20 weeks after the start of the study (time 2. Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel. Results 40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18. Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between

  12. Is a randomised controlled trial of a maternity care intervention for pregnant adolescents possible? An Australian feasibility study.

    Science.gov (United States)

    Allen, Jyai; Stapleton, Helen; Tracy, Sally; Kildea, Sue

    2013-11-13

    The way in which maternity care is provided affects perinatal outcomes for pregnant adolescents; including the likelihood of preterm birth. The study purpose was to assess the feasibility of recruiting pregnant adolescents into a randomised controlled trial, in order to inform the design of an adequately powered trial which could test the effect of caseload midwifery on preterm birth for pregnant adolescents. We recruited pregnant adolescents into a feasibility study of a prospective, un-blinded, two-arm, randomised controlled trial of caseload midwifery compared to standard care. We recorded and analysed recruitment data in order to provide estimates to be used in the design of a larger study. The proportion of women aged 15-17 years who were eligible for the study was 34% (n=10), however the proportion who agreed to be randomised was only 11% (n = 1). Barriers to recruitment were restrictive eligibility criteria, unwillingness of hospital staff to assist with recruitment, and unwillingness of pregnant adolescents to have their choice of maternity carer removed through randomisation. A randomised controlled trial of caseload midwifery care for pregnant adolescents would not be feasible in this setting without modifications to the research protocol. The recruitment plan should maximise opportunities for participation by increasing the upper age limit and enabling women to be recruited at a later gestation. Strategies to engage the support of hospital-employed staff are essential and would require substantial, and ongoing, work. A Zelen method of post-randomisation consent, monetary incentives and 'peer recruiters' could also be considered.

  13. Feasibility of Pilates exercise to decrease falls risk: a pilot randomized controlled trial in community-dwelling older people.

    Science.gov (United States)

    Barker, Anna L; Talevski, Jason; Bohensky, Megan A; Brand, Caroline A; Cameron, Peter A; Morello, Renata T

    2016-10-01

    To evaluate the feasibility of Pilates exercise in older people to decrease falls risk and inform a larger trial. Pilot Randomized controlled trial. Community physiotherapy clinic. A total of 53 community-dwelling people aged ⩾60 years (mean age, 69.3 years; age range, 61-84). A 60-minute Pilates class incorporating best practice guidelines for exercise to prevent falls, performed twice weekly for 12 weeks. All participants received a letter to their general practitioner with falls risk information, fall and fracture prevention education and home exercises. Indicators of feasibility included: acceptability (recruitment, retention, intervention adherence and participant experience survey); safety (adverse events); and potential effectiveness (fall, fall injury and injurious fall rates; standing balance; lower limb strength; and flexibility) measured at 12 and 24 weeks. Recruitment was achievable but control group drop-outs were high (23%). Of the 20 participants who completed the intervention, 19 (95%) attended ⩾75% of the classes and reported classes were enjoyable and would recommend them to others. The rate of fall injuries at 24 weeks was 42% lower and injurious fall rates 64% lower in the Pilates group, however, was not statistically significant (P = 0.347 and P = 0.136). Standing balance, lower-limb strength and flexibility improved in the Pilates group relative to the control group (P fall injury rates. A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820). © The Author(s) 2015.

  14. Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care

    Directory of Open Access Journals (Sweden)

    Weiderpass Elisabete

    2008-08-01

    Full Text Available Abstract Background Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study. Methods A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1 recruitment and participation, 2 completion of data collection, 3 realization of the intervention and 4 the public health nurses' experiences. Results 1 The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2 In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3 In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4 The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study. Conclusion The study protocol was mostly feasible to implement, which

  15. Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).

    Science.gov (United States)

    Zadro, Joshua Robert; Shirley, Debra; Simic, Milena; Mousavi, Seyed Javad; Ceprnja, Dragana; Maka, Katherine; Ferreira, Paulo

    2017-06-01

    To investigate the feasibility of implementing a video-game exercise programme for older people with chronic low back pain (LBP). Single-centred single-blinded randomised controlled trial (RCT). Physiotherapy outpatient department in a public hospital in Western Sydney, Australia. We will recruit 60 participants over 55 years old with chronic LBP from the waiting list. Participants will be randomised to receive video-game exercise (n=30) or to remain on the waiting list (n=30) for 8 weeks, with follow up at 3 and 6 months. Participants engaging in video-game exercises will be unsupervised and will complete video-game exercise for 60minutes, 3 times per week. Participants allocated to remain on the waiting list will be encouraged to maintain their usual levels of physical activity. The primary outcomes for this feasibility study will be study processes (recruitment and response rates, adherence to and experience with the intervention, and incidence of adverse events) relevant to the future design of a large RCT. Estimates of treatment efficacy (point estimates and 95% confidence intervals) on pain self-efficacy, care seeking, physical activity, fear of movement/re-injury, pain, physical function, disability, falls-efficacy, strength, and walking speed, will be our secondary outcome measures. Recruitment for this trial began in November 2015. This study describes the rationale and processes of a feasibility study investigating a video-game exercise programme for older people with chronic LBP. Results from the feasibility study will inform on the design and sample required for a large multicentre RCT. Australian New Zealand Clinical Trials Registry: ACTRN12615000703505. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  16. Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study).

    Science.gov (United States)

    Kiechle, Marion; Engel, Christoph; Berling, Anika; Hebestreit, Katrin; Bischoff, Stephan; Dukatz, Ricarda; Gerber, Wolf-Dieter; Siniatchkin, Michael; Pfeifer, Katharina; Grill, Sabine; Yahiaoui-Doktor, Maryam; Kirsch, Ellen; Niederberger, Uwe; Marter, Nicole; Enders, Ute; Löffler, Markus; Meindl, Alfons; Rhiem, Kerstin; Schmutzler, Rita; Erickson, Nicole; Halle, Martin

    2016-01-01

    Women with highly penetrant BRCA mutations have a 55-60% lifetime risk for breast cancer and a 16-59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. These include lifestyle factors such as physical activity status, dietary habits, and body weight. The modification of penetrance by changing lifestyle factors has not thus far been investigated in a randomized trial in BRCA mutation carriers. Therefore, we intend to enroll 60 BRCA1/2 mutation carriers in a pilot feasibility study (Lifestyle Intervention Study in Women with Hereditary Breast and Ovarian Cancer (LIBRE) pilot). This multi-center, prospective, controlled trial aims to randomize (1:1) participants into a (1) multi-factorial lifestyle intervention group (IG) versus (2) the control group with usual care (CG). The primary endpoint is feasibility and acceptance of a structured interdisciplinary lifestyle intervention program over 12 months (at least 70% of the patients to complete the 1-year intervention). Furthermore, the effects on physical fitness, BMI, quality of life, and stress coping capacity will be investigated. During the first 3 months, women in the IG will receive structured, individualized and mainly supervised endurance training of ≥18 MET*h/week (MET = metabolic equivalent task) and personal nutritional counseling based on the Mediterranean diet. During the subsequent 9 months, the IG will receive monthly group training sessions and regular telephone contacts for motivation, whereas the CG will only receive usual care (one general counseling on healthy nutrition and benefits of regular physical activity on health status). At randomization and subsequent time points (3, 6, 12 months), cardiopulmonary fitness will be assessed by spiroergometry and nutritional and psychological status by validated questionnaires. This pilot study will investigate the optimal strategy to improve

  17. Predicting enrollment performance of investigational centers in phase III multi-center clinical trials

    NARCIS (Netherlands)

    van den Bor, Rutger M.; Grobbee, Diederick E.; Oosterman, Bas J.; Vaessen, Petrus W J; Roes, Kit C.B.

    2017-01-01

    Failure to meet subject recruitment targets in clinical trials continues to be a widespread problem with potentially serious scientific, logistical, financial and ethical consequences. On the operational level, enrollment-related issues may be mitigated by careful site selection and by allocating

  18. Development and Validation of a Clinical Trial Accrual Predictive Regression Model at a Single NCI-Designated Comprehensive Cancer Center.

    Science.gov (United States)

    Tate, Wendy R; Cranmer, Lee D

    2016-05-01

    Clinical study sites often do not achieve anticipated accrual to clinical trials, wasting critical patient, material, and human resources. The expensive and extensive process to bring a drug to approval highlights the need to streamline clinical pipeline processes. We sought to create a predictive accrual model to be used when considering clinical trial activation at the level of the individual site. This retrospective cohort study used 7 years of registry data from treatment and supportive care interventional studies at a single academic cancer center to build a negative binomial regression model with local and protocol variables known prestudy. Actual, team-predicted, and model-predicted accrual and sensitivity/specificity were calculated. To build the model, 207 trials were used. Investigational drug application, disease team, number of national sites, local Institutional Review Board use, total national accrual time, accrual completed, and national enrollment goal were independently and significantly associated with accrual. Predicted accrual was 94% of actual, maintaining predictive value at multiple cutoff values. Validation included 61 trials. The model correctly predicted whether a study would accrue at least 4 subjects 75% of the time. Correlation at the category level was 44.3%, and model sensitivity and specificity are 70% and 78%, respectively. We identified and validated national and local key factors associated with accrual at our site. This methodology has not been previously validated broadly with the intent of trial feasibility. Model validation shows it to be an accurate and quick metric in anticipating accrual success that can be used for resource allocation. Copyright © 2016 by the National Comprehensive Cancer Network.

  19. Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

    Directory of Open Access Journals (Sweden)

    Falko F Sniehotta

    Full Text Available Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI≥30 kg/m2 adults (age≥18 y with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44; mean-BMI = 36.73(6.06 with 2.35(1.47 co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation. Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes

  20. Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial).

    Science.gov (United States)

    Steffens, Daniel; Young, Jane; Beckenkamp, Paula R; Ratcliffe, James; Rubie, Freya; Ansari, Nabila; Pillinger, Neil; Solomon, Michael

    2018-02-17

    There is a need for evidence of the effectiveness of pre-operative exercise for patients undergoing major cancer surgery; however, recruitment to such trials can be challenging. The PrE-operative Physical Activity (PEPA) Trial will establish the feasibility and acceptability of a pre-operative exercise programme aimed to improve patient outcomes after cytoreductive surgery and pelvic exenteration. The secondary aim is to obtain pilot data on the likely difference in key outcomes (post-operative complications, length of hospital stay, post-operative functional capacity and quality of life) to inform the sample size calculation for the substantive randomised clinical trial. Twenty patients undergoing cytoreductive surgery and pelvic exenteration at the Royal Prince Alfred Hospital, Sydney will be recruited and randomly allocated (1:1 ratio) to either 2 to 6 weeks' pre-operative exercise programme (intervention group) or usual care (control group). Those randomised to the intervention group will receive up to six individualised, 1-h physiotherapy sessions (including aerobic and endurance exercises, respiratory muscle exercises, stretching and flexibility exercises), home exercises (instruction and recommendations on how to progress the exercises at home) and encouragement to be more active by using an activity tracker to measure the number of steps walked daily. Patients allocated to the control group will not receive any specific advice about exercise training. Feasibility will be assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the exercise programme. Acceptability of the exercise programme will be assessed with a semi-structured questionnaire. The following measures of the effectiveness of the intervention will be collected at baseline (2 to 6 weeks pre-operative), a week before surgery, during hospital stay and pre hospital discharge: post-operative complication rates (Clavien-Dindo), post

  1. Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

    Science.gov (United States)

    Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

    2017-04-01

    contract. Contract renegotiation occurs in response to cyclical changes within the trust relationship throughout trial participation. The Integrated Model of Trust offers a novel framework to interrogate the process by which diverse populations and clinical trial teams build trust. To our knowledge, this is the first model of trust-building in clinical trials that frames trust development through integrated clinical and business perspectives. By focusing on the process, rather than outcomes of trust-building diverse trial participants, clinical trials teams, participants, and cancer centers may be able to better understand, measure, and manage their trust relationships in real time. Ultimately, this may foster increased recruitment and retention of diverse populations to clinical trials.

  2. The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

    Science.gov (United States)

    Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

    2016-01-01

    To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large

  3. Occupational Therapy in HomEcare Re-ablement Services (OTHERS): results of a feasibility randomised controlled trial.

    Science.gov (United States)

    Whitehead, Phillip J; Walker, Marion F; Parry, Ruth H; Latif, Zaid; McGeorge, Ian D; Drummond, Avril E R

    2016-08-16

    The objective of this study was to test the feasibility of conducting a randomised controlled trial (RCT) of an intervention targeted at activities of daily living (ADL), delivered by an occupational therapist, in homecare reablement. Feasibility parallel group RCT. Single-site local authority homecare reablement service. People referred for homecare reablement with ability to consent. Exclusion criteria were as follows: inability to speak English, receiving other community therapy services, needing two or more to assist transfer and receiving end-of-life care. 'Usual care' was 6 weeks of homecare reablement delivered by social care workers (no routine health professional input). A targeted ADL programme, delivered by an occupational therapist incorporating goal setting, teaching/practising techniques, equipment/adaptations and provision of advice/support. This was in addition to usual care. Aspects of feasibility including eligibility, recruitment, intervention delivery, attrition and suitability and sensitivity of outcome measures. Participant outcomes were personal and extended ADL, quality of life, falls and use of health and social care services. 30 participants were recruited, 15 to each arm, which was 60% of those eligible. Data from 22 (73%) were analysed at 6 months. Of the 15 participants, 13 (86%) received the intervention and were able to set one or more ADL goals. There were improvements from baseline in both groups, although overall improvements were greater in the occupational therapy (OT) intervention group. The biggest threat to feasibility was a change in service configuration during the trial, involving additional occupational therapy input, affecting usual care and recruitment. Despite the service reconfiguration, it was feasible to recruit and retain participants, deliver the intervention and collect outcome data that were responsive to change. The choice of primary outcome measure remains unclear. A further powered study is feasible and

  4. e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial.

    Science.gov (United States)

    van Dongen, Angelique J C M; Nelen, Willianne L D M; IntHout, Joanna; Kremer, Jan A M; Verhaak, Christianne M

    2016-05-01

    Is it feasible to evaluate a personalized e-therapy program (Internet based) for women during fertility treatment aimed to reduce the chance of having clinically relevant symptoms of anxiety and/or depression after unsuccessful assisted reproductive technology (ART) treatment within a randomized controlled trial (RCT)? The evaluation of a personalized e-therapy program is feasible, reflected by good acceptability and integration within current guidelines, but adjustments to the e-therapy program and study design of the RCT have to be made to enhance demand, practicality and efficacy. Internet-based interventions are promising in reducing psychological distress, especially when treatment is personalized to specific risk profiles of patients. However in fertility care, the beneficial effects of personalized e-therapy on psychological distress and its implementation in daily clinical care still have to be evaluated. To evaluate the feasibility of a personalized e-therapy program, we conducted a two-arm, parallel group, single-blind feasibility randomized controlled trial with a 1:1 allocation. Feasibility was assessed in terms of demand, acceptability, practicality, implementation, integration and limited efficacy. Women were included between 1 February 2011 and 1 June 2013. Women in the control group received care as usual, whereas women in the intervention group received in addition to their usual care access to a personalized e-therapy program. Women were monitored until 3 months after the start of their first ART cycle. In a university hospital in the Netherlands women who were screened as at risk for emotional adjustment problems and intended to start their first ART cycle were invited, and of them 120 were randomized. Of these women, 48% in the intervention group were compliant to the intervention. Outcome measures associated with the feasibility to analyse this e-therapy program within an RCT were assessed. It is feasible to evaluate a personalized e

  5. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

    Science.gov (United States)

    Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

    2017-01-01

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

  6. Leadership Practices of Clinical Trials Office Leaders in Academic Health Centers

    Science.gov (United States)

    Naser, Diana D.

    2012-01-01

    In the ever-changing clinical research environment, academic health centers seek leaders who are visionary and innovative. Clinical trials offices across the country are led by individuals who are charged with promoting growth and change in order to maximize performance, develop unique research initiatives, and help institutions achieve a…

  7. Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

    Science.gov (United States)

    Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

    2014-01-01

    The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

  8. Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs.

    Science.gov (United States)

    Clarke, Diana E; Wilcox, Holly C; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H; Newcomer, Alison; McKitty, Mellisha V; Regier, Darrel A; Narrow, William E

    2014-06-01

    The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients' experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. Copyright © 2013, American Psychiatric Association. All rights reserved.

  9. The feasibility of a home-based sedentary behaviour intervention for hospitalised chronic obstructive pulmonary disease (COPD patients: Sitting and ExacerbAtions Trial (COPD-SEAT

    Directory of Open Access Journals (Sweden)

    Mark Orme

    2015-10-01

    COPD-SEAT will be one of the first trials aimed at reducing sedentary behaviour at home in patients hospitalised for an acute exacerbation of COPD. This trial will provide valuable insight into the feasibility of implementing an at-home technology-based feedback intervention for reducing sedentary behaviour into patients existing care. Findings will inform a future large-scale trial acting as an adjuvant to pulmonary rehabilitation.

  10. Open Trial of Vinyasa Yoga for Persistently Depressed Individuals: Evidence of Feasibility and Acceptability

    Science.gov (United States)

    Uebelacker, Lisa A.; Tremont, Geoffrey; Epstein-Lubow, Gary; Gaudiano, Brandon A.; Gillette, Tom; Kalibatseva, Zornitsa; Miller, Ivan W.

    2010-01-01

    The aim of this study was to assess the acceptability and feasibility of Vinyasa yoga as an adjunctive treatment for depressed patients who were not responding adequately to antidepressant medication. The authors also planned to ask participants for qualitative feedback on their experience of the class and to assess change over time in depression…

  11. Teen Choices, an Online Stage-Based Program for Healthy, Nonviolent Relationships: Development and Feasibility Trial

    Science.gov (United States)

    Levesque, Deborah A.; Johnson, Janet L.; Prochaska, Janice M.

    2017-01-01

    This article describes the theoretical foundation, development, and feasibility testing of an online, evidence-based intervention for teen dating violence prevention designed for dissemination. Teen Choices, a program for healthy, nonviolent relationships, relies on the transtheoretical model of behavior change and expert system technology to…

  12. Making co-enrolment feasible for randomised controlled trials in paediatric intensive care.

    Directory of Open Access Journals (Sweden)

    Katie Harron

    Full Text Available Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU. We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren comparing impregnated with standard central venous catheters (CVCs for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP. Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running, due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82% and 18/35 (51% for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.

  13. Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

    Science.gov (United States)

    Gravenstein, Stefan; Davidson, H Edward; Han, Lisa F; Ogarek, Jessica A; Dahal, Roshani; Gozalo, Pedro L; Taljaard, Monica; Mor, Vincent

    2017-11-01

    Influenza severity increases and vaccine effectiveness decreases with age. High-Dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare-care certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care random assignment with HD (Fluzone® High-Dose) or SD (Fluzone®) influenza vaccine for their facility for the 2012-2013 influenza season. We used Minimum Data Set (MDS) 3.0 and Vital Status records for pre-specified clinical outcomes: 1) all-cause hospitalization, 2) NH mortality, and 3) functional decline. Intent-to-treat analyses were performed at the resident-level using Cox proportional hazards, multivariable Poisson, and logistic regression models accounting for clustering by facility. We randomized 39 NHs (19 SD and 20 HD), coordinated vaccine delivery, implemented web-based data collection, and accessed MDS data, demonstrating feasibility. There were 2,957 eligible residents (SD 1496; HD 1461); characteristics were similar between groups. A total of 301 (20.1%) of SD and 197 (13.5%) of HD allocated residents were ever hospitalized, (adjusted relative risk 0.680; 95% CI: 0.537, 0.862; p = 0.001). NH mortality was 274 (18.3%) SD vs 249 (17.1%) HD, adjusted relative risk 0.834; 95% CI: 0.678, 1.027; p = 0.087). There were no differences in decline in functional status (13.4 vs 13.8%, adjusted relative risk 0.994; 95% CI: 0.774,1.278; p = 0.965). We demonstrate that a pragmatic large-scale trial is feasible in a NH setting.

  14. Feasibility and effects of preventive home visits for at-risk older people: Design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Catellier Diane

    2009-12-01

    Full Text Available Abstract Background The search for preventive methods to mitigate functional decline and unwanted relocation by older adults living in the community is important. Preventive home visit (PHV models use infrequent but regular visits to older adults by trained practitioners with the goal of maintaining function and quality of life. Evidence about PHV efficacy is mixed but generally supportive. Yet interventions have rarely combined a comprehensive (biopsychosocial occupational therapy intervention protocol with a home visit to older adults. There is a particular need in the USA to create and examine such a protocol. Methods/Design The study is a single-blind randomized controlled pilot trial designed to assess the feasibility, and to obtain preliminary efficacy estimates, of an intervention consisting of preventive home visits to community-dwelling older adults. An occupational therapy-based preventive home visit (PHV intervention was developed and is being implemented and evaluated using a repeated measures design. We recruited a sample of 110 from a population of older adults (75+ who were screened and found to be at-risk for functional decline. Participants are currently living in the community (not in assisted living or a skilled nursing facility in one of three central North Carolina counties. After consent, participants were randomly assigned into experimental and comparison groups. The experimental group receives the intervention 4 times over a 12 month follow-up period while the comparison group receives a minimal intervention of mailed printed materials. Pre- and post-intervention measures are being gathered by questionnaires administered face-to-face by a treatment-blinded research associate. Key outcome measures include functional ability, participation, life satisfaction, self-rated health, and depression. Additional information is collected from participants in the experimental group during the intervention to assess the feasibility of

  15. Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size

    Directory of Open Access Journals (Sweden)

    Mudano AS

    2013-06-01

    Full Text Available Amy S Mudano,1,2,3 Lisa C Gary,1,2,3 Ana L Oliveira,1,2,3 Mary Melton,1,2,3 Nicole C Wright,1,2,3 Jeffrey R Curtis,1,2,3 Elizabeth Delzell,1,2,3 T Michael Harrington,1,2,3 Meredith L Kilgore,1,2,3 Cora Elizabeth Lewis,1,2,3 Jasvinder A Singh,1,2,3,4 Amy H Warriner,1,2,3 Wilson D Pace,5 Kenneth G Saag1,2,31Center for Education and Research on Therapeutics (CERTs, 2Center for Outcomes Effectiveness Research and Education (COERE, and 3Center for Clinical and Translational Sciences (CCTS, (University of Alabama at Birmingham, Birmingham, AL, USA; 4Veterans Affairs Medical Center, Birmingham, AL, USA; 5Distributed Ambulatory Research in Therapeutics Network (DARTNet, American Academy of Family Physicians (AAFP, University of Colorado, Denver, CO, USAIntroduction: Pragmatic clinical trials (PCTs provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS for patient recruitment and screening for an osteoporosis PCT in community physician offices.Materials and methods: We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.Results: A total of 160 women (80% of those approached agreed to complete the osteoporosis screening questions in ten family physicians’ offices. Women using the

  16. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi.

    Science.gov (United States)

    Dawson, Katie S; Schafer, Alison; Anjuri, Dorothy; Ndogoni, Lincoln; Musyoki, Caroline; Sijbrandij, Marit; van Ommeren, Mark; Bryant, Richard A

    2016-11-18

    Living in conditions of chronic adversity renders many women more vulnerable to experiencing gender-based violence (GBV). In addition to GBV's physical and social consequences, the psychological effects can be pervasive. Access to evidence-based psychological interventions that seek to support the mental health of women affected by such adversity is rare in low- and middle-income countries. The current study evaluates a brief evidence-informed psychological intervention developed by the World Health Organization for adults impacted by adversity (Problem Management Plus; PM+). A feasibility randomised control trial (RCT) was conducted to inform a fully powered trial. Community health workers delivered the intervention to 70 women residing in three peri-urban settings in Nairobi, Kenya. Women, among whom 80% were survivors of GBV (N = 56), were randomised to receive five sessions of either PM+ (n = 35) by community health workers or enhanced treatment as usual (ETAU; n = 35). PM+ was not associated with any adverse events. Although the study was not powered to identify effects and accordingly did not identify effects on the primary outcome measure of general psychological distress, women survivors of adversity, including GBV, who received PM+ displayed greater reductions in posttraumatic stress disorder symptoms following treatment than those receiving ETAU. This feasibility study suggests that PM+ delivered by lay health workers is an acceptable and safe intervention to reach women experiencing common mental disorders and be inclusive for those affected by GBV and can be studied in a RCT in this setting. The study sets the stage for a fully powered, definitive controlled trial to assess this potentially effective intervention. ACTRN12614001291673 , 10/12/2014, retrospectively registered during the recruitment phase.

  17. Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial.

    Science.gov (United States)

    Powell, Jane E; Carroll, Fran E; Sebire, Simon J; Haase, Anne M; Jago, Russell

    2013-12-20

    There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors. This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study. 3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120). Girls aged 11-12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities. Programme costs and girls' preferences for attributes of dance and preferences for competing leisure time activities were measured. The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was $70.90, £44.31 and €51.84 in 2010-2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h. This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated.

  18. The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Brooke M Winzer

    Full Text Available To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett's oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development.A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions in inactive, overweight/obese (25.0-34.9 kg/m2 males with Barrett's oesophagus, aged 18-70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]. Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value.Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80; 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01. Effects on primary outcomes were not statistically significant.This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this

  19. Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.

    Science.gov (United States)

    Pye, Kirstie; Totton, Nicola; Stuart, Nicholas; Whitaker, Rhiannon; Morrison, Val; Edwards, Rhiannon Tudor; Yeo, Seow Tien; Timmis, Laura J; Butterworth, Caryl; Hall, Liz; Rai, Tekendra; Hoare, Zoe; Neal, Richard D; Wilkinson, Clare; Leeson, Simon

    2016-01-01

    Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment. The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation. The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention. ISRCTN45565436.

  20. Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Oblasser, Claudia; McCourt, Christine; Hanzal, Engelbert; Christie, Janice

    2016-04-01

    This paper presents a feasibility trial protocol the purpose of which is to prepare for a future randomised controlled trial to determine the effectiveness of vibrating vaginal pelvic floor training balls for postpartum pelvic floor muscle rehabilitation. Vibrating vaginal pelvic floor training balls are available in Austria to enhance women's pelvic floor muscles and thus prevent or treat urinary incontinence and other pelvic floor problems following childbirth. Nonetheless, there is currently little empirical knowledge to substantiate their use or assess their relative effectiveness in comparison to current standard care, which involves pelvic floor muscle exercises. Single blind, randomised controlled feasibility trial with two parallel groups. It is planned to recruit 56 postpartum women in Vienna, who will be randomised into one of two intervention groups to use either vibrating vaginal balls or a comparator pelvic floor muscle exercises for 12 weeks. As this is a feasibility study, study design features (recruitment, selection, randomisation, intervention concordance, data collection methods and tools) will be assessed and participants' views and experiences will be surveyed. Tested outcome measures, collected before and after the intervention, will be pelvic floor muscle performance as reported by participants and measured by perineometry. Descriptive and inferential statistics and content analysis will serve the preparation of the future trial. The results of this feasibility trial will inform the design and conduct of a full randomised controlled trial and provide insight into the experiences of women regarding the interventions and study participation. © 2015 John Wiley & Sons Ltd.

  1. Revie ⊕: the influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer-a study protocol for a feasibility study using a mixed method investigation.

    Science.gov (United States)

    Da Rocha Rodrigues, Maria Goreti; Pautex, Sophie; Shaha, Maya

    2016-01-01

    It is generally recognized that existential concerns must be addressed to promote the dignity of patients with advanced cancer. A number of interventions have been developed in this regard, such as dignity therapy and other life review interventions (LRI). However, so far, none have focused on a positive approach or evaluated its effects on dignity and personal growth. This study aims to explore the feasibility of Revie ⊕, a life review intervention comprising a positive, patient-centered approach, and to determine potential changes of patients' sense of dignity, posttraumatic growth, and satisfaction with life. A mixed method study will be performed, which includes specialized nurses and 40 patients with advanced cancer in an ambulatory and in-patient setting of a Swiss university hospital. Quantitative methods involve a single group, pre- and post-intervention, and outcome measurements include the Patient Dignity Inventory, the Posttraumatic Growth Inventory, and the Satisfaction with Life Scale. Feasibility data relating to process, resource, and scientific elements of the trial will also be collected. A semi-directed interview will be used to collect qualitative data about the process and the participants' experiences of the intervention. In this way, enhanced quantitative-qualitative evidence can be drawn from outcome measures as well as individual, contextualized personal views, to help inform researchers about the plausibility of this complex intervention before testing its effectiveness in a subsequent full trial. Patient dignity is a goal of quality end-of-life care. To our knowledge, this is the first trial to evaluate the role of a life review intervention that is focused on personal growth and on changes relating to the experience of having cancer. This study will evaluate the feasibility of a novel intervention, Revie ⊕, which we hope will contribute to promote the dignity, personal growth, and overall life satisfaction of patients with advanced

  2. Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol.

    Science.gov (United States)

    Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

    2018-01-31

    Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or 'third -wave' CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016-0107). The Ffindings will be used to improve the intervention per user

  3. Improved clinical trial enrollments for uterine leiomyosarcoma patients after gynecologic oncology partnership with a sarcoma center.

    Science.gov (United States)

    Lange, S E S; Liu, J; Adkins, D R; Powell, M A; Van Tine, B A; Mutch, D G

    2016-02-01

    A retrospective chart review was performed to determine patient outcomes before and after partnership by gynecologic oncologists (GYN/ONC) with a sarcoma center (SC) for patients with recurrent unresectable/metastatic (RM) uterine leiomyosarcoma (uLMS). 58 RM patients, identified from medical records of uLMS patients cared for by either GYN/ONC service and/or the SC between 1/1/2000-4/1/2014, were audited for patient and tumor characteristics, outcomes, and clinical trials enrollments. Of the 58 patients, 26 patients (48%) were treated by GYN/ONC alone and 32 were treated by a combination of GYN/ONC and SC (52%). Age, race, tumor size, grade, presence of lymphovascular invasion, cervical involvement, and FIGO stage at diagnosis were not statistically different between the two groups. There was a significant difference between the number of clinical trial enrollments (0.07 vs 0.84 trials/patient, p<0.001) and the number of chemotherapy regimens prescribed (2.67 vs 4.29/patient, p=0.03) by GYN/ONC vs SC; the latter was driven by the number of clinical trial enrollments by the SC. Sixty-nine percent of patients referred to the SC were enrolled in at least one clinical trial, while just 8% of patients in the GYN/ONC group were enrolled in at least one clinical trial, a difference that is significant (p<0.0001). Referral of RM uLMS patients by GYN/ONC to a dedicated clinical trials-based SC resulted in an increase in the number of chemotherapy regimens prescribed and clinical trial enrollments. Partnership between GYN/ONC and a dedicated SC with access to clinical trials should be encouraged for all RM uLMS patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Wildcat wellness coaching feasibility trial: protocol for home-based health behavior mentoring in girls.

    Science.gov (United States)

    Cull, Brooke J; Rosenkranz, Sara K; Dzewaltowski, David A; Teeman, Colby S; Knutson, Cassandra K; Rosenkranz, Richard R

    2016-01-01

    Childhood obesity is a major public health problem, with one third of America's children classified as either overweight or obese. Obesity prevention and health promotion programs using components such as wellness coaching and home-based interventions have shown promise, but there is a lack of published research evaluating the impact of a combined home-based and wellness coaching intervention for obesity prevention and health promotion in young girls. The main objective of this study is to test the feasibility of such an intervention on metrics related to recruitment, intervention delivery, and health-related outcome assessments. The secondary outcome is to evaluate the possibility of change in health-related psychosocial, behavioral, and biomedical outcomes in our sample of participants. Forty girls who are overweight or obese (aged 8-13 years) will be recruited from a Midwestern college town. Participants will be recruited through posted flyers, newspaper advertisements, email, and social media. The volunteer convenience sample of girls will be randomized to one of two home-based wellness coaching interventions: a general health education condition or a healthy eating physical activity skills condition. Trained female wellness coaches will conduct weekly hour-long home visits for 12 consecutive weeks. Assessments will occur at baseline, post-intervention (3 months after baseline), and follow-up (6 months after baseline) and will include height, weight, waist circumference, body composition, pulmonary function, blood pressure, systemic inflammation, physical activity (Actical accelerometer), and self-reported survey measures (relevant to fruit and vegetable consumption, physical activity, and quality of life). This study will evaluate the feasibility of home-based wellness coaching interventions for overweight and obese girls and secondarily assess the preliminary impact on health-related psychosocial, behavioral, and biomedical outcomes. Results will provide

  5. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit?acquired weakness: A pilot feasibility trial ? ??

    OpenAIRE

    Connolly, Bronwen; Thompson, April; Douiri, Abdel; Moxham, John; Hart, Nicholas

    2015-01-01

    Purpose The aim of this study was to investigate feasibility of exercise-based rehabilitation delivered after hospital discharge in patients with intensive care unit?acquired weakness (ICU-AW). Materials and methods Twenty adult patients, mechanically ventilated for more than 48 hours, with ICU-AW diagnosis at ICU discharge were included in a pilot feasibility randomized controlled trial receiving a 16-session exercise-based rehabilitation program. Twenty-one patients without ICU-AW participa...

  6. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials.

    Science.gov (United States)

    Wallace, Andrea R; Teitelbaum, Aaron; Wan, Livia; Mulima, Maria Gloria; Guichard, Laura; Skoler, Stephanie; Skiler, Stephanie; Vilakazi, Hlengiwe; Mapula, Fridda S; Rossier, Jasmine; Govender, Sumen N; Lahteenmaki, Pekka; Maguire, Robin A; Phillips, David M

    2007-07-01

    Participant's adherence to use of study product is a major concern in microbicide clinical trials, which can impact on proving product efficacy. In a previously described assay, single-use microbicide applicators exposed to the vagina were tested by spraying the applicator with trypan blue dye, resulting in vaginal mucus staining on inserted applicators. As subjects in our Phase 3 trials return applicators only at quarterly visits, often mixing inserted and not-inserted applicators together in the same bag, cross-contamination could confound results. In addition, trypan blue is carcinogenic and thus potentially hazardous to technicians spraying daily. Applicators that were exposed to the vagina were placed in the same bag as unexposed applicators and shaken daily for up to 4 months. Validation was carried out in three clinical sites in South Africa. Trypan blue was replaced with FD&C Blue #1 granular food dye. Cross-contamination did not occur, nor did the length of time affect reaction to dye. In South Africa, the assay was validated with an accuracy of over 95%. Applicator assay modifications render the test safe and suitable for use in clinical trials.

  7. Clinical and biomarker changes in premanifest Huntington disease show trial feasibility: a decade of the PREDICT-HD study

    Directory of Open Access Journals (Sweden)

    Jane S Paulsen

    2014-04-01

    Full Text Available There is growing consensus that intervention and treatment of Huntington disease (HD should occur at the earliest stage possible. Various early-intervention methods for this fatal neurodegenerative disease have been identified, but preventive clinical trials for HD are limited by a lack of knowledge of the natural history of the disease and a dearth of appropriate outcome measures. Objectives of the current study are to document the natural history of premanifest HD progression in the largest cohort ever studied and to develop a battery of imaging and clinical markers of premanifest HD progression that can be used as outcome measures in preventive clinical trials. PREDICT-HD is a 32-site, international, observational study of premanifest HD, with annual examination of 1013 participants with premanifest HD and 301 gene-expansion negative controls between 2001 and 2012. Findings document 39 variables representing imaging, motor, cognitive, functional, and psychiatric domains, showing different rates of decline between premanifest Huntington disease and controls. Required sample size and models of premanifest HD are presented to inform future design of clinical and preclinical research. Preventive clinical trials in premanifest HD with participants who have a medium or high probability of motor onset are calculated to be as resource-effective as those conducted in diagnosed HD and could interrupt disease seven to twelve years earlier. Methods and measures for preventive clinical trials in premanifest HD more than a dozen years from motor onset are also feasible. These findings represent the most thorough documentation of a clinical battery for experimental therapeutics in stages of premanifest HD, the time period for which effective intervention may provide the most positive possible outcome for patients and their families affected by this devastating disease.

  8. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study.

    Science.gov (United States)

    Scianni, Aline; Teixeira-Salmela, Luci F; Ada, Louise

    2012-01-01

    There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. The aims of this study were to 1) determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2) compare the effectiveness of various recruitment strategies on accrual rates, and 3) determine the attendance at training sessions and adherence to the intervention protocol. Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23%) were eligible. Twenty-five of these patients (71%) were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%). Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.

  9. Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Low, Joseph; Serfaty, Marc; Davis, Sarah; Vickerstaff, Victoria; Gola, Anna; Omar, Rumana Z; King, Michael; Tookman, Adrian; Austen, Janet St John; Turner, Karen; Jones, Louise

    2016-02-11

    One-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people's ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions. This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies--General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants' experiences of the trial and therapy. Data will be collected on the costs of care. Data generated on the recruitment, retention, and experience of the

  10. School-based health center-based treatment for obese adolescents: feasibility and body mass index effects.

    Science.gov (United States)

    Love-Osborne, Kathy; Fortune, Rachel; Sheeder, Jeanelle; Federico, Steven; Haemer, Matthew A

    2014-10-01

    School-based health centers (SBHCs) may be an ideal setting to address obesity in adolescents because they provide increased access to a traditionally difficult-to-reach population. The study evaluated the feasibility of adding a health educator (HE) to SBHC teams to provide support and increase the delivery of preventive services for overweight or obese adolescents. Adolescents with BMI ≥85% recruited from two SBHCs were randomized to a control group (CG) or an intervention group (IG). Both groups received preventive services, including physical examinations and laboratory screening in the SBHC. The educator met with the IG during the academic year, utilizing motivational interviewing techniques to set lifestyle goals. Text messaging was used to reinforce goals between visits. Eighty-two students (15.7±1.5 years of age; BMI, 31.9±6.2 kg/m(2)) were enrolled in the IG and 83 in the control group (16.0±1.5 years of age; BMI, 31.6±6.5 kg/m(2)). Retention was 94% in the IG and 87% in the CG. A total of 54.5% of the IG and 72.2% of the CG decreased or maintained BMI z-score (less than 0.05 increase; p=0.025). Sports participation was higher in the CG (47% vs. 28% in the IG; p=0.02). Mean BMI z-score change was -0.05±0.2 for students participating in sports vs. 0.01±0.2 for those not (p=0.09). This SBHC intervention showed successful recruitment and retention of participants and delivery of preventive services in both groups. Meeting with an HE did not improve BMI outcomes in the IG. Confounding factors, including sports participation and SBHC utilization, likely contributed to BMI outcomes.

  11. Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion.

    Science.gov (United States)

    McIlvaine, Elizabeth; Borzabadi-Farahani, Ali; Lane, Christianne J; Azen, Stanley P; Yen, Stephen L-K

    2014-05-01

    To assess the feasibility of randomizing treatment (surgical vs. non-surgical) for correction of a Class III malocclusion (underbite) resulting from an earlier repair of cleft lip and palate. Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palate patients under the care of Children's Hospital Los Angeles between 2005 and 2010. The inclusion criteria were patients with cleft lip and palate, Class III malocclusion due to maxillary deficiency, and absence of medical and cognitive contraindications to treatment. Out of 287 surveys, 82 (28%) were completed and returned; 47% of the subjects held a strong treatment preference (95% CI, 35-58%), while 30% were willing to accept randomization (95% CI, 20-41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with the assigned treatment (95% CI, 67-86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1) the desire for doctors to choose the best treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible. Based on this study, parents and patients would be unwilling to accept a randomly assigned treatment and would not remain in an assigned group if treatment did not meet expectations. This highlight the limitations associated with randomization trials involving surgical modalities and provide justification for other research models (e.g., cohort studies) to compare two treatment options when randomization is not feasible. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  12. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility.

    Science.gov (United States)

    Wójcicki, Thomas R; Grigsby-Toussaint, Diana; Hillman, Charles H; Huhman, Marian; McAuley, Edward

    2014-10-30

    The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group's administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be

  13. Addressing behavioral impacts of childhood leukemia: A feasibility pilot randomized controlled trial of a group videoconferencing parenting intervention.

    Science.gov (United States)

    Williams, Lauren K; McCarthy, Maria C; Burke, Kylie; Anderson, Vicki; Rinehart, Nicole

    2016-10-01

    Child emotional and behavioral problems constitute significant sequelae of acute lymphoblastic leukemia (ALL) treatment. The aims of this study were to a) examine the feasibility, acceptability and satisfaction of a parenting intervention amongst parents of children with ALL and b) explore whether participation in a parenting intervention shows promise for improvements in child behavior. 12 parents with a child aged between 2 and 8 years receiving maintenance phase treatment for ALL participated in a phase 2 randomized controlled trial comparing eight weeks of group online participation in Triple P: Positive Parenting Program with no intervention. The number of eligible parents who completed the intervention was low (31.6%). Main reasons for non-consent or dropout were program time commitment too high or content not relevant. For parents who completed the intervention, satisfaction and acceptability was high. Parents reported the intervention as highly relevant and topical, feasible, helpful and a positive experience. Results indicated a non-significant trend towards improved total child behavioral and emotional difficulties following the intervention. Qualitative results indicated that intervention group parents reported improvements in parenting skills and competence, and decreased child behavioral problems. These pilot data highlight the difficulties of engaging and retaining parents in an 8-week parenting intervention in this context. For parents who completed the intervention, results indicated high feasibility, acceptability and satisfaction. Suggestions for further research and intervention modifications are provided to enhance uptake and strengthen efforts to assist parents in addressing child behavioral and emotional challenges during ALL treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial.

    Science.gov (United States)

    Purwar, B; Ismail, K M; Turner, N; Farrell, A; Verzune, M; Annappa, M; Smith, I; El-Gizawy, Zeiad; Cooper, J C

    2015-08-01

    Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient's subjective perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

  15. 'Better Health Choices' by telephone: a feasibility trial of improving diet and physical activity in people diagnosed with psychotic disorders.

    Science.gov (United States)

    Baker, Amanda L; Turner, Alyna; Kelly, Peter J; Spring, Bonnie; Callister, Robin; Collins, Clare E; Woodcock, Kathryn L; Kay-Lambkin, Frances J; Devir, Holly; Lewin, Terry J

    2014-12-15

    The study objective was to evaluate the feasibility of a telephone delivered intervention consisting of motivational interviewing and cognitive behavioural strategies aimed at improving diet and physical activity in people diagnosed with psychotic disorders. Twenty participants diagnosed with a non-acute psychotic disorder were recruited. The intervention consisted of eight telephone delivered sessions targeting fruit and vegetable (F&V) consumption and leisure screen time, as well as smoking and alcohol use (as appropriate). F&V frequency and variety, and overall diet quality (measured by the Australian Recommended Food Score, ARFS), leisure screen time, overall sitting and walking time, smoking, alcohol consumption, mood, quality of life, and global functioning were examined before and 4-weeks post-treatment. Nineteen participants (95%) completed all intervention sessions, and 17 (85%) completed follow-up assessments. Significant increases from baseline to post-treatment were seen in ARFS fruit, vegetable and overall diet quality scores, quality of life and global functioning. Significant reductions in leisure screen time and overall sitting time were also seen. Results indicated that a telephone delivered intervention targeting key cardiovascular disease risk behaviours appears to be feasible and relatively effective in the short-term for people diagnosed with psychosis. A randomized controlled trial is warranted to replicate and extend these findings. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  16. Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

    Science.gov (United States)

    Gardiner, Paula M; McCue, Kelly D; Negash, Lily M; Cheng, Teresa; White, Laura F; Yinusa-Nyahkoon, Leanne; Jack, Brian W; Bickmore, Timothy W

    2017-09-01

    This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Improved quality monitoring of multi-center acupuncture clinical trials in China.

    Science.gov (United States)

    Zhao, Ling; Liang, Fan-rong; Li, Ying; Zhang, Fu-wen; Zheng, Hui; Wu, Xi

    2009-12-27

    In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  18. Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Klasen, Elizabeth; Miranda, J Jaime; Khatry, Subarna; Menya, Diana; Gilman, Robert H; Tielsch, James M; Kennedy, Caitlin; Dreibelbis, Robert; Naithani, Neha; Kimaiyo, Sylvester; Chiang, Marilu; Carter, E Jane; Sherman, Charles B; Breysse, Patrick N; Checkley, William

    2013-10-10

    Exposure to biomass fuel smoke is one of the leading risk factors for disease burden worldwide. International campaigns are currently promoting the widespread adoption of improved cookstoves in resource-limited settings, yet little is known about the cultural and social barriers to successful improved cookstove adoption and how these barriers affect environmental exposures and health outcomes. We plan to conduct a one-year crossover, feasibility intervention trial in three resource-limited settings (Kenya, Nepal and Peru). We will enroll 40 to 46 female primary cooks aged 20 to 49 years in each site (total 120 to 138). At baseline, we will collect information on sociodemographic characteristics and cooking practices, and measure respiratory health and blood pressure for all participating women. An initial observational period of four months while households use their traditional, open-fire design cookstoves will take place prior to randomization. All participants will then be randomized to receive one of two types of improved, ventilated cookstoves with a chimney: a commercially-constructed cookstove (Envirofit G3300/G3355) or a locally-constructed cookstove. After four months of observation, participants will crossover and receive the other improved cookstove design and be followed for another four months. During each of the three four-month study periods, we will collect monthly information on self-reported respiratory symptoms, cooking practices, compliance with cookstove use (intervention periods only), and measure peak expiratory flow, forced expiratory volume at 1 second, exhaled carbon monoxide and blood pressure. We will also measure pulmonary function testing in the women participants and 24-hour kitchen particulate matter and carbon monoxide levels at least once per period. Findings from this study will help us better understand the behavioral, biological, and environmental changes that occur with a cookstove intervention. If this trial indicates that

  19. The effects of exercise on cognitive function and brain plasticity - a feasibility trial.

    Science.gov (United States)

    Gomes-Osman, Joyce; Cabral, Danylo F; Hinchman, Carrie; Jannati, Ali; Morris, Timothy P; Pascual-Leone, Alvaro

    2017-01-01

    Exercise-mediated cognitive improvements can be at least partly attributed to neuroplastic changes in the nervous system, and may be influenced by the Val66Met polymorphism of the brain-derived neurotrophic factor (BDNF) gene. Transcranial magnetic stimulation (TMS) can be used to assess mechanisms of plasticity in humans noninvasively. To assess the feasibility of evaluating the effects of short-term regular exercise on cognitive performance, and to evaluate the relationship between these effects, TMS measures of plasticity, and BDNF Met carrier status in young healthy sedentary adults. Of the 19 participants who enrolled in the study, 14 sedentary adults (12 females, age mean±SD, 27±12.3 yr), with less than two sessions of physical exercise in the preceding 2 months, completed an aerobic exercise regimen including four 30-min daily sessions per week for 4 weeks (for a total of 16 sessions) delivered at 55-64% of age-predicted maximal heart rate. Prior to and following the exercise regimen, participants performed a neuropsychological test battery and an intermittent theta-burst TMS plasticity protocol. All participants completed the various measures and adhered to the exercise regimen. There were no complications and the results obtained were reliable. The feasibility of the approach is thus well established. Between-group comparisons of pre-post change revealed trends toward increased performance on the Stroop and faster reaction times in the CPT detectability in the Val66Val subgroup (p = 0.07 and p = 0.08), and a reduction in TBS-induced modulation of TMS responses in Met carriers (p = 0.07). Acute exercise interventions in sedentary adults can be meaningfully conducted along with cognitive and neurophysiologic measures to assess behavioral and neurobiological effects and assessment of BDNF polymorphism. TMS measures of plasticity can be used to evaluate the effects of exercise on brain plasticity, and relate them to neuropsychological measures

  20. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol.

    Science.gov (United States)

    Khalifa, N; Talbot, E; Schneider, J; Walker, D M; Bates, P; Bird, Y; Davies, D; Brookes, C; Hall, J; Völlm, B

    2016-07-22

    People with involvement in forensic psychiatric services face many obstacles to employment, arising from their offending, as well as their mental health problems. This study aims to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of individual placement and support (IPS), in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations. IPS has been found consistently to achieve employment rates above 50% in psychiatric patients without a history of involvement in criminal justice services. This is a single-centre feasibility cluster RCT. Clusters will be defined according to clinical services in the community forensic services of Nottinghamshire Healthcare NHS Foundation Trust (NHCT). IPS will be implemented into 2 of the randomly assigned intervention clusters in the community forensic services of NHCT. A feasibility cluster RCT will estimate the parameters required to design a full RCT. The primary outcome is the proportion of people in open employment at 12-month follow-up. Secondary outcome measures will include employment, educational activities, psychosocial and economic outcomes, as well as reoffending rates. Outcome measures will be recorded at baseline, 6 months and 12 months. In accordance with the UK Medical Research Council guidelines on the evaluation of complex interventions, a process evaluation will be carried out; qualitative interviews with patients and staff will explore general views of IPS as well as barriers and facilitators to implementation. Fidelity reviews will assess the extent to which the services follow the principles of IPS prior, during and at the end of the trial. Ethical approval was obtained from the East Midlands Research Ethics Committee-Nottingham 1 (REC reference number 15/EM/0253). Final and interim reports will be prepared for project funders, the study sponsor and clinical research network. Findings will be disseminated through

  1. The Economic and Risk Constraints in the Feasibility Analysis of Wireless Communications in Marine Corps Combat Operation Centers

    Science.gov (United States)

    2013-09-01

    TOC Tactical Operations Center UOC Unit Operations Center USMC United States Marine Corps VLAN Virtual Local Area Network WIDS Wireless Intrusion...Marine Corps COC CapSets. The Combat Operations Center (COC), originally known as the unit operations center ( UOC ) when it first came out, is

  2. Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial.

    Science.gov (United States)

    Himes, Katherine Park; Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

    2017-10-10

    During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and

  3. Bridges self-management program for people with stroke in the community: A feasibility randomized controlled trial.

    Science.gov (United States)

    McKenna, Suzanne; Jones, Fiona; Glenfield, Pauline; Lennon, Sheila

    2015-07-01

    Enabling self-management behaviors is considered important in order to develop coping strategies and confidence for managing life with a long-term condition. However, there is limited research into stroke-specific self-management interventions. The aim of this randomized controlled trial was to evaluate the feasibility of delivering the Bridges stroke self-management program in addition to usual stroke rehabilitation compared with usual rehabilitation only. Participants recruited from the referrals to a community stroke team were randomly allocated to the Bridges stroke self-management program, receiving either one session of up to one-hour per week over a six-week period in addition to usual stroke rehabilitation, or usual rehabilitation only. Feasibility was measured using a range of methods to determine recruitment and retention; adherence to the program; suitability and variability of outcome measures used; application and fidelity of the program; and acceptability of the program to patients, carers and professionals. Twenty-five people were recruited to the study over a 13-month period. Eight out of the 12 participants in the Bridges stroke self-management program received all six sessions; there was one withdrawal from the study. There were changes in outcomes between the two groups. Participants who received the Bridges stroke self-management program appeared to have a greater change in self-efficacy, functional activity, social integration and quality of life over the six-week intervention period and showed less decline in mood and quality of life at the three-month follow-up. Professionals found the program acceptable to use in practice, and feedback from participants was broadly positive. The findings from this study appear promising, but questions remain regarding the feasibility of delivering the Bridges stroke self-management program in addition to usual rehabilitation. The dose response of receiving the program cannot be ruled out, and the next stage

  4. Back to the future – feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Langford DP

    2015-09-01

    Full Text Available Dolores P Langford,1,2 Lena Fleig,3–5 Kristin C Brown,3,4 Nancy J Cho,1,2 Maeve Frost,1 Monique Ledoyen,1 Jayne Lehn,1 Kostas Panagiotopoulos,1,6 Nina Sharpe,1 Maureen C Ashe3,4 1Vancouver Coastal Health, 2Department of Physical Therapy, The University of British Columbia (UBC, 3Department of Family Practice, The University of British Columbia (UBC, 4Centre for Hip Health and Mobility, Vancouver, BC, Canada; 5Freie Universität Berlin, Health Psychology, Berlin, Germany; 6Department of Orthopaedics, The University of British Columbia (UBC, Vancouver, BC, Canada Objectives: Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching, and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture.Design: This is a parallel 1:1 randomized controlled feasibility study.Setting: The study was conducted in a teaching hospital in Vancouver, BC, Canada.Participants: Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation.Intervention: Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos.Measurement: Our primary outcome was feasibility, specifically recruitment

  5. Recovery from disability for individuals with borderline personality disorder: a feasibility trial of DBT-ACES.

    Science.gov (United States)

    Comtois, Katherine Anne; Kerbrat, Amanda Holland; Atkins, David C; Harned, Melanie S; Elwood, Lynn

    2010-11-01

    Employment and recovery can be difficult goals to reach for individuals with severe borderline personality disorder, even for those who have successfully completed dialectical behavior therapy (DBT) and are no longer in crisis. This study examined the feasibility of DBT-Accepting the Challenges of Exiting the System (DBT-ACES), a follow-up to standard DBT (SDBT). A pre-post evaluation was conducted of the outcomes for 30 clients with borderline personality disorder who entered DBT-ACES during the study period (April 2000 to June 2005). Outcomes included employment, exit from the public mental health system, and quality of life, as well as self-inflicted injury and emergency and inpatient admissions. From the end of SDBT to the end of DBT-ACES, the study found a significant improvement in participants' odds of being employed or in school (odds ratio [OR]=3.34, ppersonality disorder with a combination of SDBT and DBT-ACES, but controlled research is needed.

  6. Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT): Study Protocol of a Randomized Controlled Feasibility Trial.

    Science.gov (United States)

    Sajonz, Bastian Elmar Alexander; Amtage, Florian; Reinacher, Peter Christoph; Jenkner, Carolin; Piroth, Tobias; Kätzler, Jürgen; Urbach, Horst; Coenen, Volker Arnd

    2016-12-22

    Essential tremor is a movement disorder that can result in profound disability affecting the quality of life. Medically refractory essential tremor can be successfully reduced by deep brain stimulation (DBS) traditionally targeting the thalamic ventral intermediate nucleus (Vim). Although this structure can be identified with magnetic resonance (MR) imaging nowadays, Vim-DBS electrodes are still implanted in the awake patient with intraoperative tremor testing to achieve satisfactory tremor control. This can be attributed to the fact that the more effective target of DBS seems to be the stimulation of fiber tracts rather than subcortical nuclei like the Vim. There is evidence that current coverage of the dentatorubrothalamic tract (DRT) results in good tremor control in Vim-DBS. Diffusion tensor MR imaging (DTI) tractography-assisted stereotactic surgery targeting the DRT would therefore not rely on multiple trajectories and intraoperative tremor testing in the awake patient, bearing the potential of more patient comfort and reduced operation-related risks. This is the first randomized controlled trial comparing DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia with stereotactic surgery of thalamic/subthalamic region as conventionally used. This clinical pilot trial aims at demonstrating safety of DTI tractography-assisted stereotactic surgery in general anesthesia and proving its equality compared to conventional stereotactic surgery with intraoperative testing in the awake patient. The Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT) trial is a single-center investigator-initiated, randomized, controlled, observer-blinded trial. A total of 24 patients with medically refractory essential tremor will be randomized to either DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia or stereotactic surgery of the thalamic/subthalamic region as conventionally used. The

  7. Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT).

    Science.gov (United States)

    Russell, Ailsa; Cooper, Kate; Barton, Stephen; Ensum, Ian; Gaunt, Daisy; Horwood, Jeremy; Ingham, Barry; Kessler, David; Metcalfe, Chris; Parr, Jeremy; Rai, Dheeraj; Wiles, Nicola

    2017-12-03

    High rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression. A feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is under way as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual. Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger-scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design. Ethical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership and Northumberland, Tyne and Wear Foundation NHS Trusts. To our knowledge, this is the first study of a low-intensity intervention for depression in adults with autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study and

  8. Initiation of home mechanical ventilation at home: a randomised controlled trial of efficacy, feasibility and costs.

    Science.gov (United States)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-09-01

    Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting. Seventy-seven patients were included, of which 38 patients started HMV at home. All patients were diagnosed with chronic respiratory failure due to a neuromuscular or thoracic cage disease. Primary outcome was the arterial carbon dioxide (PaCO2) while quality of life and costs were secondary outcomes. Telemonitoring was used in the home group to provide therapeutic information, for example; transcutaneous carbon dioxide, oxygen saturation and ventilator information, to the caregivers. Follow-up was six months. PaCO2, improved by 0.72 (SE ± 0.16) kPa in the hospital group and by 0.91 (±0.20) in the home group, both improvements being significant and the latter clearly not inferior. There were also significant improvements in quality of life in both groups, again not being inferior with home treatment. This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation. In addition we found that it is safe, technically feasible and that more than € 3000 per patient can be saved compared to our standard care. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Design of the muscles in motion study: a randomized controlled trial to evaluate the efficacy and feasibility of an individually tailored home-based exercise training program for children and adolescents with juvenile dermatomyositis

    Directory of Open Access Journals (Sweden)

    Habers Esther A

    2012-06-01

    Full Text Available Abstract Background Juvenile dermatomyositis (JDM is a rare, often chronic, systemic autoimmune disease of childhood, characterized by inflammation of the microvasculature of the skeletal muscle and skin. Prominent clinical features include significant exercise intolerance, muscle weakness, and fatigue. Despite pharmacological improvements, these clinical features continue to affect patients with JDM, even when the disease is in remission. Exercise training is increasingly utilized as a non-pharmacological intervention in the clinical management of (adult patients with chronic inflammatory conditions; however no randomized controlled trials (RCT have been performed in JDM. In the current study, the efficacy and feasibility of an exercise training program in patients with JDM will be examined. Methods/design Subjects (n = 30 will include 8–18 year olds diagnosed with JDM. The intervention consists of an individually tailored 12-weeks home-based exercise training program in which interval training on a treadmill is alternated with strength training during each session. The program is based on previous literature and designed with a defined frequency, intensity, time, and type of exercise (FITT principles. Primary outcome measures include aerobic exercise capacity, isometric muscle strength, and perception of fatigue. The study methodology has been conceived according to the standards of the CONSORT guidelines. The current study will be a multi-center (4 Dutch University Medical Centers RCT, with the control group also entering the training arm directly after completion of the initial protocol. Randomization is stratified according to age and gender. Discussion The current study will provide evidence on the efficacy and feasibility of an individually tailored 12-week home-based exercise training program in youth with JDM. Trial registration Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands: 11–336

  10. Laparoscopic Sphincter Augmentation Device Eliminates Reflux Symptoms and Normalizes Esophageal Acid Exposure One- and 2-Year Results of a Feasibility Trial

    NARCIS (Netherlands)

    Bonavina, Luigi; Demeester, Tom; Fockens, Paul; Dunn, Daniel; Saino, Greta; Bona, Davide; Lipham, John; Bemelman, Willem; Ganz, Robert A.

    2010-01-01

    Objectives: One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD).

  11. Feasibility of assessing quality of care at the end of life in two cluster trials using an after-death approach with multiple assessments

    NARCIS (Netherlands)

    West, E.; Romoli, V.; Di Leo, S.; Higginson, I.J.; Miccinesi, G.; Costantini, M.

    2014-01-01

    Background: In 2009 two randomised cluster trials took place to assess the introduction of the Italian Version of the Liverpool Care Pathway in hospitals and hospices. Before and after data were gathered. The primary aim of this study is to evaluate the feasibility of using a combination of

  12. Feasibility of a home-based exercise intervention with remote guidance for patients with stable grade II and III gliomas : A pilot randomized controlled trial

    NARCIS (Netherlands)

    Gehring, K.; Kloek, C.J.J.; Aaronson, Neil K; Janssen, K.; Jones, Lee; Sitskoorn, M.M.; Stuiver, M.

    2018-01-01

    Objective: In this pilot study, we investigated the feasibility of a home-based, remotely guided exercise intervention for patients with gliomas. Design: Pilot randomized controlled trial (RCT) with randomization (2:1) to exercise or control group. Subjects: Patients with stable grade II and III

  13. Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men.

    Science.gov (United States)

    Crombie, Iain K; Cunningham, Kathryn B; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose; Jones, Claire; Briggs, Andrew; Rice, Peter M; Achison, Marcus; McKenzie, Andrew; Dimova, Elena; Slane, Peter W

    2017-04-01

    Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. Men were recruited from the community, from primary care registers and by time-space sampling (TSS). The intervention was delivered in community settings such as the participant's home, community centres and libraries. Men aged 35-64 years who had a body mass index (BMI) of > 30 kg/m(2) and who drank > 21 units of alcohol per week. The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the

  14. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Ko, Seok-Jae; Park, Jae-Woo; Kim, Jinsung; Yeo, Inkwon; Lee, Hyejung; Kim, Song-Yi; Lee, Hyangsook

    2014-03-22

    Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck's depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers' Institutional Review Boards. Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. ClinicalTrials.gov Identifier: NCT01921504.

  15. Docetaxel monotherapy in heavily pretreated metastatic breast cancer: a multicenter, community-based feasibility trial.

    Science.gov (United States)

    Schmidinger, M; Budinsky, A C; Wenzel, C; Locker, G J; Pluschnig, U; Brodowicz, T; Kubista, E; Maca, S; Zabernigg, A; Ilsinger, P; Seewann, L; Hojas, S; Blach, M; Zielinski, C C; Steger, G G

    2001-01-01

    To evaluate the efficacy and safety of docetaxel in heavily pretreated and anthracycline-resistant patients with metastatic breast cancer in an outpatient setting. Between February 1996 and June 1998, 98 consecutive patients who had progressed during or relapsed following prior anthracycline-containing chemotherapy were enrolled into the trial. Docetaxel was administered at a dose of 100 mg/m2 by intravenous infusion every 3 weeks. The administration of colony-stimulating factors was at the discretion of the attending physician. Premedication with dexamethasone was mandatory for all patients. Of the 98 patients, 93 were evaluable for toxicity and response. Patients had received two palliative regimens (median, range 1-5) prior to docetaxel treatment. The most frequent toxicity observed was leukopenia grade III and IV (WHO grading system) which occurred in 47% of patients (grade IV only in 14%). Except for alopecia grade III (64% of patients), nonhematologic side effects grade III-IV were rare (1-7% of patients) and included nausea, stomatitis, diarrhea, peripheral neuropathy, fluid retention and pulmonary toxicities. There were no treatment-related deaths. Objective responses occurred in 40% of patients (CR 6%, PR 34%), and stable disease in 38% of patients. The median duration of response was 5.3 months (range 0.7-18.1 months) while the median survival was 15 months (range 2 36 months). Docetaxel is a highly active agent in patients with anthracycline-resistant metastatic breast cancer, even in heavily pretreated patients, with moderate toxicity.

  16. Physical activity, immune function and inflammation in kidney patients (the PINK study): a feasibility trial protocol.

    Science.gov (United States)

    Highton, Patrick James; Neale, Jill; Wilkinson, Thomas J; Bishop, Nicolette C; Smith, Alice C

    2017-05-29

    Patients with chronic kidney disease (CKD) display increased infection-related mortality and elevated cardiovascular risk only partly attributed to traditional risk factors. Patients with CKD also exhibit a pro-inflammatory environment and impaired immune function. Aerobic exercise has the potential to positively impact these detriments, but is under-researched in this patient population. This feasibility study will investigate the effects of acute aerobic exercise on inflammation and immune function in patients with CKD to inform the design of larger studies intended to ultimately influence current exercise recommendations. Patients with CKD, including renal transplant recipients, will visit the laboratory on two occasions, both preceded by appropriate exercise, alcohol and caffeine restrictions. On visit 1, baseline assessments will be completed, comprising anthropometrics, body composition, cardiovascular function and fatigue and leisure time exercise questionnaires. Participants will then undertake an incremental shuttle walk test to estimate predicted peak O 2 consumption (VO 2 peak). On visit 2, participants will complete a 20 min shuttle walk at a constant speed to achieve 85% estimated VO 2 peak. Blood and saliva samples will be taken before, immediately after and 1 hour after this exercise bout. Muscle O 2 saturation will be monitored throughout exercise and recovery. Age and sex-matched non-CKD 'healthy control' participants will complete an identical protocol. Blood and saliva samples will be analysed for markers of inflammation and immune function, using cytometric bead array and flow cytometry techniques. Appropriate statistical tests will be used to analyse the data. A favourable opinion was granted by the East Midlands-Derby Research Ethics Committee on 18 September 2015 (ref 15/EM/0391), and the study was approved and sponsored by University Hospitals of Leicester Research and Innovation (ref 11444). The study was registered with ISRCTN (ref

  17. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Yu-Lun Lo

    Full Text Available There are safety issues associated with propofol use for flexible bronchoscopy (FB. The bispectral index (BIS correlates well with the level of consciousness. The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation, benefiting the patients and bronchoscopists.After administering alfentanil bolus, 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 (study group or incremental midazolam bolus based on clinical judgment to achieve moderate sedation. The primary endpoint was safety, while the secondary endpoints were recovery time, patient tolerance, and cooperation.The proportion of patients with hypoxemia or hypotensive events were not different in the 2 groups (study vs. control groups: 39.9% vs. 35.7%, p = 0.340; 7.4% vs. 4.4%, p = 0.159, respectively. The mean lowest blood pressure was lower in the study group. Logistic regression revealed male gender, higher American Society of Anesthesiologists physical status, and electrocautery were associated with hypoxemia, whereas lower propofol dose for induction was associated with hypotension in the study group. The study group had better global tolerance (p<0.001, less procedural interference by movement or cough (13.6% vs. 36.1%, p<0.001; 30.0% vs. 44.2%, p = 0.001, respectively, and shorter time to orientation and ambulation (11.7±10.2 min vs. 29.7±26.8 min, p<0.001; 30.0±18.2 min vs. 55.7±40.6 min, p<0.001, respectively compared to the control group.BIS-guided propofol infusion combined with alfentanil for FB sedation provides excellent patient tolerance, with fast recovery and less procedure interference.ClinicalTrials. gov NCT00789815.

  18. Voluntary Medical Male Circumcision to Prevent HIV in Tanah Papua, Indonesia: Field Trial to Assess Acceptability and Feasibility.

    Science.gov (United States)

    Ansari, M Ridwan; Lazuardi, Elan; Wignall, Frank Stephen; Karma, Constant; Sumule, Sylvanus A; Tarmizi, Siti Nadia; Magnani, Robert

    2017-11-23

    Relatively little attention has been paid to the significant HIV prevention role that voluntary medical male circumcision (VMMC) can play in populations with moderate levels of HIV prevalence. One such location is Tanah Papua, Indonesia, which in 2013 had a general population having HIV prevalence of 2.3% concentrated among indigenous Papuans (2.9% prevalence), very few of whom are circumcised. This article reports the findings of an implementation research study assessing the acceptability and feasibility of introducing VMMC for HIV prevention. Following a situational assessment and socialization of targeted groups of men and key stakeholders, a single-arm, open-label, prospective cohort trial using the non-surgical PrePex® device was undertaken in four cities. Study participants were recruited via study-associated socialization events. Data were collected from clients prior to and following device insertion, and at several "check-up" points (2-, 21- and 42-days) using standardized case report forms. A random sample of circumcision clients from one city was surveyed six months' post-removal to assess the prevalence of compensatory sexual risk behaviours. Demand for circumcision was weak in three of the cities, reflecting insufficient prior socialization and lingering concerns over religious appropriateness and safety issues. Despite no prior experience with PrePex ®, the pilot implementation yielded side-effect and adverse event rates that were unremarkable in comparison with sub-Saharan African countries, where PrePex ® is widely used. No evidence of increased post-procedure sexual risk-taking was found. The study findings point to both opportunity and significant challenges in introducing VMMC on a large scale in Tanah Papua, Indonesia. Although there were enough promising signs in the qualitative research and in the limited-scale implementation trial undertaken to remain optimistic as to the potential for VMMC to help contain HIV in Tanah Papua, much remains

  19. Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial.

    Science.gov (United States)

    Selby, Peter; Hussain, Sarwar; Voci, Sabrina; Zawertailo, Laurie

    2015-10-01

    feasibility of using the Internet and free medication to enable smokers to engage physicians to treat this addiction. Implementation of this intervention can be scaled up by leveraging existing healthcare systems to treat smokers on a population level. Further evaluation in a randomized controlled trial is necessary. ClinicalTrials.gov Identifier NCT01023659.

  20. Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kimani-Murage, Elizabeth W; Kimiywe, Judith; Kabue, Mark; Wekesah, Frederick; Matiri, Evelyn; Muhia, Nelson; Wanjohi, Milka; Muriuki, Peterrock; Samburu, Betty; Kanyuira, James N; Young, Sera L; Griffiths, Paula L; Madise, Nyovani J; McGarvey, Stephen T

    2015-09-28

    Interventions promoting optimal infant and young child nutrition could prevent a fifth of under-5 deaths in countries with high mortality. Poor infant and young child feeding practices are widely documented in Kenya, with potential detrimental effects on child growth, health and survival. Effective strategies to improve these practices are needed. This study aims to pilot implementation of the Baby Friendly Community Initiative (BFCI), a global initiative aimed at promoting optimal infant and young child feeding practices, to determine its feasibility and effectiveness with regards to infant feeding practices, nutrition and health outcomes in a rural setting in Kenya. The study, employing a cluster-randomized trial design, will be conducted in rural Kenya. A total of 12 clusters, constituting community units within the government's Community Health Strategy, will be randomized, with half allocated to the intervention and the other half to the control arm. A total of 812 pregnant women and their respective children will be recruited into the study. The mother-child pairs will be followed up until the child is 6 months old. Recruitment will last approximately 1 year from January 2015, and the study will run for 3 years, from 2014 to 2016. The intervention will involve regular counseling and support of mothers by trained community health workers and health professionals on maternal, infant and young child nutrition. Regular assessment of knowledge, attitudes and practices on maternal, infant and young child nutrition will be done, coupled with assessment of nutritional status of the mother-child pairs and morbidity for the children. Statistical methods will include analysis of covariance, multinomial logistic regression and multilevel modeling. The study is funded by the NIH and USAID through the Program for Enhanced Research (PEER) Health. Findings from the study outlined in this protocol will inform potential feasibility and effectiveness of a community

  1. Randomized Clinical Trial of Dialectical Behavior Therapy for Preadolescent Children With Disruptive Mood Dysregulation Disorder: Feasibility and Outcomes.

    Science.gov (United States)

    Perepletchikova, Francheska; Nathanson, Donald; Axelrod, Seth R; Merrill, Caitlin; Walker, Amy; Grossman, Meredith; Rebeta, James; Scahill, Lawrence; Kaufman, Joan; Flye, Barbara; Mauer, Elizabeth; Walkup, John

    2017-10-01

    Persistent irritability and behavior outbursts in disruptive mood dysregulation disorder (DMDD) are associated with severe impairment in childhood and with negative adolescent and adult outcomes. There are no empirically established treatments for DMDD. This study examined the feasibility and preliminary efficacy of dialectical behavior therapy adapted for preadolescent children (DBT-C) with DMDD. Children 7 to 12 years old with DMDD (N = 43) were randomly assigned 1:1 to DBT-C or treatment as usual (TAU). The 6 domains of feasibility included recruitment, randomization, retention, attendance, participants' satisfaction, and therapist adherence. Blinded raters assessed participants at baseline, after 8, 16, 24, and 32 weeks, and at 3-month follow-up. The primary efficacy outcome was the positive response rate on the Clinical Global Impression-Improvement scale. Improvements in behavior outbursts and angry/irritable mood were assessed by the Clinical Global Impression-Severity scale. Mean number of participants randomized per month was 2.53 ± 2.72. Participants in DBT-C (n = 21) attended 89% of sessions compared with 48.6% in TAU (n = 22). Eight TAU participants (36.4%) dropped out compared with none in DBT-C. Parents and children in DBT-C expressed significantly higher treatment satisfaction than those in TAU. The rate of positive response was 90.4% in DBT-C compared with 45.5% in TAU, despite 3 times as many participants in TAU receiving psychiatric medications. Remission rates were 52.4% for DBT-C and 27.3% for TAU. Improvements were maintained at 3-month follow-up. Therapists showed adherence to DBT-C. DBT-C demonstrated feasibility in all prespecified domains. Outcomes also indicated preliminary efficacy of DBT-C. Clinical trial registration information-Adapting DBT for Children With DMDD: Pilot RCT; http://clinicaltrials.gov/; NCT01862549. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  2. Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial

    Directory of Open Access Journals (Sweden)

    Yardley Lucy

    2010-11-01

    Full Text Available Abstract Background IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. Methods/Design The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic and methylcellulose (bulking-agent and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. Discussion This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help

  3. Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial.

    Science.gov (United States)

    Powell, Kingsley; Wilson, Victoria J; Redmond, Niamh M; Gaunt, Daisy M; Ridd, Matthew J

    2016-11-17

    Recruiting to target in randomised controlled trials of investigational medicinal products (CTIMPs) in primary care and paediatric populations is notoriously difficult. More evidence is needed for effective recruitment strategies in these settings. We report on the impact of different recruitment strategies used in the Choice of Moisturiser in Eczema Treatment (COMET) study - a feasibility trial comparing the effectiveness of four emollients for the treatment of childhood eczema - recruiting via general practitioner (GP) surgeries. Initially, 16 GP practices invited potentially eligible children to take part in the trial by sending an invitation letter (self-referral pathway) or by consenting and randomising them into the study during a visit to the practice (in-consultation referral). Measures implemented during the study to maximise accrual included signing up six additional GP practices, increasing the upper age limit eligibility criterion from 3 to 5 years, and permitting healthcare professionals other than doctors to confirm participant eligibility. We used descriptive statistics and univariate linear regression models to explore associations with practice recruitment rates. A total of 197 participants were recruited, exceeding the target of 160. Of these, 107 children entered via self-referral and 90 by in-consultation pathways. Of the recruited population, 12.6 % were aged between 3 and 5 years (the raised upper age limit). The six additional practices contributed 37.4 % (40 of 107) of participants recruited by self-referral. Only almost one-third (18 of 56 [32.1 %]) of potential recruiting clinicians recruited one or more participants in-consultation, which was a more problematic pathway because of data verification issues. Three research nurses and a pharmacist from four practices recruited 48.9 % (44 of 90) of participants via this pathway. Univariate linear regression models showed no evidence of association between the number of children recruited

  4. Improved quality monitoring of multi-center acupuncture clinical trials in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2009-12-01

    Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  5. Autism Spectrum Social Stories In Schools Trial (ASSSIST): study protocol for a feasibility randomised controlled trial analysing clinical and cost-effectiveness of Social Stories in mainstream schools.

    Science.gov (United States)

    Wright, Barry; Marshall, David; Collingridge Moore, Danielle; Ainsworth, Hannah; Hackney, Lisa; Adamson, Joy; Ali, Shehzad; Allgar, Victoria; Cook, Liz; Dyson, Lisa; Littlewood, Elizabeth; Hargate, Rebecca; McLaren, Anne; McMillan, Dean; Trépel, Dominic; Whitehead, Jo; Williams, Chris

    2014-07-09

    Current evidence suggests that Social Stories can be effective in tackling problem behaviours exhibited by children with autism spectrum disorder. Exploring the meaning of behaviour from a child's perspective allows stories to provide social information that is tailored to their needs. Case reports in children with autism have suggested that these stories can lead to a number of benefits including improvements in social interactions and choice making in educational settings. The feasibility of clinical and cost-effectiveness of a Social Stories toolkit will be assessed using a randomised control framework. Participants (n=50) will be randomised to either the Social Stories intervention or a comparator group where they will be read standard stories for an equivalent amount of time. Statistics will be calculated for recruitment rates, follow-up rates and attrition. Economic analysis will determine appropriate measures of generic health and resource use categories for cost-effectiveness analysis. Qualitative analysis will ascertain information on perceptions about the feasibility and acceptability of the intervention. National Health Service Ethics Approval (NHS; ref 11/YH/0340) for the trial protocol has been obtained along with NHS Research and Development permission from Leeds and York Partnership NHS Foundation Trust. All adverse events will be closely monitored, documented and reported to the study Data Monitoring Ethics Committee. At least one article in a peer reviewed journal will be published and research findings presented at relevant conferences. ISRCTN96286707. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. User Participation and Engagement With the See Me Smoke-Free mHealth App: Prospective Feasibility Trial.

    Science.gov (United States)

    Schmidt, Chris A; Romine, James K; Bell, Melanie L; Armin, Julie; Gordon, Judith S

    2017-10-09

    The See Me Smoke-Free (SMSF) mobile health (mHealth) app was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy through cognitive behavioral techniques and guided imagery audio files addressing smoking, diet, and physical activity. A feasibility trial found associations between SMSF usage and positive treatment outcomes. This paper reports a detailed exploration of program use among eligible individuals consenting to study participation and completing the baseline survey (participants) and ineligible or nonconsenting app installers (nonparticipants), as well as the relationship between program use and treatment outcomes. The aim of this study was to determine whether (1) participants were more likely to set quit dates, be current smokers, and report higher levels of smoking at baseline than nonparticipants; (2) participants opened the app and listened to audio files more frequently than nonparticipants; and (3) participants with more app usage had a higher likelihood of self-reported smoking abstinence at follow up. The SMSF feasibility trial was a single arm, within-subjects, prospective cohort study with assessments at baseline and 30 and 90 days post enrollment. The SMSF app was deployed on the Google Play Store for download, and basic profile characteristics were obtained for all app installers. Additional variables were assessed for study participants. Participants were prompted to use the app daily during study participation. Crude differences in baseline characteristics between trial participants and nonparticipants were evaluated using t tests (continuous variables) and Fisher exact tests (categorical variables). Exact Poisson tests were used to assess group-level differences in mean usage rates over the full study period using aggregate Google Analytics data on participation and usage. Negative binomial regression models were used to estimate associations of app usage with participant baseline

  7. APEC Harmonization Center: challenges and issues relating to multiregional clinical trials in the APEC region.

    Science.gov (United States)

    Park, K L; Kim, T G; Seong, S K; Lee, S Y; Kim, S H

    2012-04-01

    The Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC) was established in 2009 with the purpose of promoting harmonization of regulatory processes for drugs and medical devices. The AHC held three training workshops on multiregional clinical trials (MRCTs); these workshops provided forums for discussing the value and potential benefits of MRCTs. Participants from regulatory agencies, the pharmaceutical industry, and academia identified many issues and made recommendations for resolving major challenges with the aim of improving the capacity of the Asia-Pacific region to carry out MRCTs.

  8. A study to assess the feasibility of undertaking a randomized controlled trial of adherence with eye drops in glaucoma patients.

    Science.gov (United States)

    Richardson, Cliff; Brunton, Lisa; Olleveant, Nicola; Henson, David B; Pilling, Mark; Mottershead, Jane; Fenerty, Cecilia H; Spencer, Anne Fiona; Waterman, Heather

    2013-01-01

    Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12). Adherence was also measured objectively using a Medical Events Monitoring System device. Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was considered to be an objective surrogate measure for adherence with eye drops. A multicenter, randomized, controlled equivalence trial of group versus individualized education using adherence as the primary outcome is the next step.

  9. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU.

    Science.gov (United States)

    Hodgson, Carol L; Bailey, Michael; Bellomo, Rinaldo; Berney, Susan; Buhr, Heidi; Denehy, Linda; Gabbe, Belinda; Harrold, Megan; Higgins, Alisa; Iwashyna, Theodore J; Papworth, Rebecca; Parke, Rachael; Patman, Shane; Presneill, Jeffrey; Saxena, Manoj; Skinner, Elizabeth; Tipping, Claire; Young, Paul; Webb, Steven

    2016-06-01

    To determine if the early goal-directed mobilization intervention could be delivered to patients receiving mechanical ventilation with increased maximal levels of activity compared with standard care. A pilot randomized controlled trial. Five ICUs in Australia and New Zealand. Fifty critically ill adults mechanically ventilated for greater than 24 hours. Patients were randomly assigned to either early goal-directed mobilization (intervention) or to standard care (control). Early goal-directed mobilization comprised functional rehabilitation treatment conducted at the highest level of activity possible for that patient assessed by the ICU mobility scale while receiving mechanical ventilation. The ICU mobility scale, strength, ventilation duration, ICU and hospital length of stay, and total inpatient (acute and rehabilitation) stay as well as 6-month post-ICU discharge health-related quality of life, activities of daily living, and anxiety and depression were recorded. The mean age was 61 years and 60% were men. The highest level of activity (ICU mobility scale) recorded during the ICU stay between the intervention and control groups was mean (95% CI) 7.3 (6.3-8.3) versus 5.9 (4.9-6.9), p = 0.05. The proportion of patients who walked in ICU was almost doubled with early goal-directed mobilization (intervention n = 19 [66%] vs control n = 8 [38%]; p = 0.05). There was no difference in total inpatient stay (d) between the intervention versus control groups (20 [15-35] vs 34 [18-43]; p = 0.37). There were no adverse events. Key Practice Points: Delivery of early goal-directed mobilization within a randomized controlled trial was feasible, safe and resulted in increased duration and level of active exercises.

  10. Randomised controlled trial of school-based humanistic counselling for emotional distress in young people: Feasibility study and preliminary indications of efficacy

    Science.gov (United States)

    2010-01-01

    Aims The purpose of this study was to test the feasibility of a randomised controlled trial comparing six weeks of humanistic school-based counselling versus waiting list in the reduction of emotional distress in young people, and to obtain initial indications of efficacy. Methods Following a screening procedure, young people (13 - 15 years old) who experienced emotional distress were randomised to either humanistic counselling or waiting list in this multi-site study. Outcomes were assessed using a range of self-report mental health measures, with the emotional symptoms subscale of the Strengths and Difficulties Questionnaire (SDQ) acting as the primary outcome indicator. Results Recruitment procedures were successful, with 32 young people consenting to participate in the trial and 27 completing endpoint measures. Trial procedures were acceptable to all involved in the research. No significant differences were found between the counselling and waiting list groups in reductions in levels of emotional symptoms (Hedges' g = 0.03), but clients allocated to counselling showed significantly greater improvement in prosocial behaviour (g = 0.89) with an average effect size (g) across the nine outcome measures of 0.25. Participants with higher levels of depressive symptoms showed significantly greater change. Conclusion This study suggested that a randomised controlled trial of counselling in schools is acceptable and feasible, although initial indications of efficacy are mixed. Trial registration Current Controlled Trials ISRCTN68290510. PMID:20412578

  11. Early results of a safety and feasibility clinical trial of a novel single-port flexible robot for transoral robotic surgery.

    Science.gov (United States)

    Chan, Jason Y K; Wong, Eddy W Y; Tsang, Raymond K; Holsinger, F Christopher; Tong, Michael C F; Chiu, Philip W Y; Ng, Simon S M

    2017-11-01

    The aim of this study was to describe the early results of a phase 1 safety and feasibility clinical trial of the first clinical use of a novel robot for transoral robotic surgery (TORS)-the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA). Study design of this study is prospective clinical trial. The methods used in this study are prospective innovation, development, exploration, assessment, and long-term study phase 1 clinical trial. Early results of six patients underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) demonstrate access the nasopharynx, oropharynx, larynx, and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all six patients. The early results of this safety and feasibility trial of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) clearly demonstrate that the device is safe and that it is feasible in performing TORS to access the nasopharynx, oropharynx, larynx, and hypopharynx.

  12. Using an internet intervention to support self-management of low back pain in primary care: protocol for a randomised controlled feasibility trial (SupportBack).

    Science.gov (United States)

    Geraghty, Adam W A; Stanford, Rosie; Little, Paul; Roberts, Lisa; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine; Stuart, Beth; Turner, David; Yardley, Lucy

    2015-09-23

    Low back pain (LBP) is a prevalent and costly condition. The majority of patients experiencing LBP are managed in primary care, where first-line care recommendations consist of advice to self-manage and remain active. Internet interventions present a potential means of providing patients with tailored self-management advice and evidence-based support for increasing physical activity. This protocol describes a single-blind, randomised controlled feasibility trial of an internet intervention developed to support the self-management of LBP in primary care. Patients are being randomised to 1 of 3 groups receiving either usual primary care, usual primary care with the addition of an internet intervention or an internet intervention with physiotherapist telephone support. Patients are followed up at 3 months. Primary outcomes are the feasibility of (1) the trial design/methods, (2) the delivery of the internet intervention and (3) the provision of telephone support by physiotherapists. Secondary outcomes will include exploratory analysis of estimates and variation in clinical outcomes of pain and disability, in order to inform a future main trial. This feasibility trial has undergone ethical scrutiny and been approved by the National Health Service (NHS) Research Ethics Committee, REC Reference 13/SC/0202. The feasibility findings will be disseminated to the research community through presentations at conferences and publication in peer review journals. Broader dissemination will come following a definitive trial. ISRCTN 31034004. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial.

    Science.gov (United States)

    Elkashef, Ahmed; Kahn, Roberta; Yu, Elmer; Iturriaga, Erin; Li, Shou-Hua; Anderson, Ann; Chiang, Nora; Ait-Daoud, Nassima; Weiss, David; McSherry, Frances; Serpi, Tracey; Rawson, Richard; Hrymoc, Mark; Weis, Dennis; McCann, Michael; Pham, Tony; Stock, Christopher; Dickinson, Ruth; Campbell, Jan; Gorodetzky, Charles; Haning, William; Carlton, Barry; Mawhinney, Joseph; Li, Ming D; Johnson, Bankole A

    2012-07-01

      Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction.   Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment.   The trial was conducted at eight medical centers in the United States.   One hundred and forty methamphetamine-dependent adults took part in the trial.   The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.   In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated.   Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  14. Safety and feasibiLIty of Metformin in patients with Impaired glucose Tolerance and a recent TIA or minor ischemic stroke (LIMIT) trial - a multicenter, randomized, open-label phase II trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; Vermeer, S. E.; Zandbergen, A. A M; Achterberg, Sefanja; Dippel, Diederik W J; Algra, Ale; Kappelle, L. J.; Koudstaal, Peter J.

    2015-01-01

    Background and purpose: We aimed to assess the safety, feasibility, and effects on glucose metabolism of treatment with metformin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. Methods: We performed a multicenter, randomized, controlled, open-label phase II trial with

  15. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Thomas, James S; France, Christopher R; Applegate, Megan E; Leitkam, Samuel T; Walkowski, Stevan

    2016-12-01

    Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is entertaining and distracting. We recruited 52 participants (48% female) with CLBP and high fear of movement and randomized them to either a game group (n = 26) or a control group (n = 26). All participants completed a pregame baseline and a follow-up assessment (4-6 days later) of lumbar spine motion and expectations of pain and harm during standardized reaches to high (easier), middle, and low (hardest to reach) targets. For 3 consecutive days, participants in the game group completed 15 minutes of virtual dodgeball between baseline and follow-up. For the standardized reaching tests, there were no significant effects of group on changes in lumbar spine flexion, expected pain, or expected harm. However, virtual dodgeball was effective at increasing lumbar flexion within and across gameplay sessions. Participants reported strong positive endorsement of the game, no increases in medication use, pain, or disability, and no adverse events. Although these findings indicate that very brief exposure to this game did not translate to significant changes outside the game environment, this was not surprising because graded exposure therapy for fear of movement among individuals with low back pain typically last 8 to 12 sessions. Because of the demonstration of safety, feasibility, and ability to encourage lumbar flexion within gameplay, these findings provide support for a clinical trial wherein the treatment dose is more consistent with traditional graded exposure approaches to CLBP. This study of a

  16. Recruiting young people with a visible difference to the YP Face IT feasibility trial: a qualitative exploration of primary care staff experiences.

    Science.gov (United States)

    Hamlet, Claire; Williamson, Heidi; Harcourt, Diana

    2017-11-01

    Qualitative research methods embedded within feasibility trials are of significant value as they can provide important information for a definitive trial, often unable to be fulfilled by quantitative methods alone. In addition, such information can aid researchers running other trials or evaluating interventions on a similar topic. Aim This study aimed to explore GP and nurses' experiences of recruiting to a trial exploring the feasibility of evaluating YP Face IT, a novel online psychosocial intervention to support young people with appearance-altering conditions. During the recruitment period, a focus group with participating GPs and nurses explored recruitment challenges. In addition, at the end of the recruitment period, telephone interviews were conducted with eight GPs and nurses involved in recruiting to the study, in order to inform a definitive trial of YP Face IT. Transcripts were subjected to thematic analysis. Findings Despite reporting that the study was valuable and interesting, interviewees struggled to recruit in-consultation. They appeared to lack confidence in raising the sensitive issue of a visible difference and adopted strategies to avoid mentioning the topic. Participants felt the nature of the target population, as well as pressures of the primary care environment presented challenges to recruitment, but welcomed YP Face IT as an intervention that could address unmet support needs. Primary care staff may benefit from training to help them raise the subject of a visible difference with young people in order to identify those that require additional support.

  17. Protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Tomkinson, Keeley; Garfield, Kirsty; Lyons, Ronan A; Simon, Joanne; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer-supporters. Approximately 15 % of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer-supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer-supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully-powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a

  18. A study to assess the feasibility of undertaking a randomized controlled trial of adherence with eye drops in glaucoma patients

    Directory of Open Access Journals (Sweden)

    Richardson C

    2013-10-01

    Full Text Available Cliff Richardson,1 Lisa Brunton,1 Nicola Olleveant,1 David B Henson,1 Mark Pilling,1 Jane Mottershead,2 Cecilia H Fenerty,2 Anne Fiona Spencer,2 Heather Waterman1 1School of Nursing, Midwifery and Social Work, University of Manchester, 2Royal Manchester Eye Hospital, Central Manchester Foundation Trust, Manchester, United Kingdom Background: Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. Methods: People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12. Adherence was also measured objectively using a Medical Events Monitoring System device. Results: Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. Conclusion: All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was

  19. Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    S.A. Costigan

    2015-01-01

    Full Text Available Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6 years were randomized into one of three conditions: aerobic exercise program (AEP (n = 21, resistance and aerobic exercise program (RAP (n = 22 and control (n = 22. The 8-week intervention consisted of three HIIT sessions per week (8–10 min/session, delivered during physical education (PE lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run, muscular fitness (push-up, standing long jump tests, body composition (Body Mass Index (BMI, BMI-z scores, waist circumference and physical activity motivation (questionnaire, by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024, BMI-z (p = 0.037 and BMI (not significant in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

  20. Pilot study of feasibility of a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy.

    Science.gov (United States)

    Riley, Judith; Hunt, Anna; McDouall, Alice; Waqanivavalagi, Steve; Braithwaite, Irene; Weatherall, Mark; Stanley, Thorsten; Beasley, Richard; Mitchell, Edwin A; Dalziel, Stuart R

    2016-10-14

    To undertake a randomised controlled trial (RCT) of paracetamol versus ibuprofen use during infancy to determine if paracetamol is associated with an increased risk of developing asthma, the preferred method of recruitment needs to be determined. We assessed three different recruitment domains to determine the likely enrolment rates of newborn infants into a three-year or six-year RCT of paracetamol versus ibuprofen and the development of asthma symptoms. The proposed RCT would require 1,806 participants. A questionnaire was administered to a convenience sample of Auckland and Wellington based parents/guardians within three different recruitment domains: antenatal classes, postnatal wards and six-week well-child visits at primary healthcare centres. Over a twelve-week period 19/586 (3.2%), 196/861 (22.8%), and 0/110 (0%) questionnaires were completed by parents/guardians of newborn infants in antenatal, postnatal and primary healthcare domains. In the postnatal recruitment domain, the likelihood of newborn infants being enrolled in the proposed RCT was rated 'very likely', 'likely' and 'neutral' by 15 (8%, CI 4-12%), 65 (33%, CI 26-40%) and 64 (33%, CI 25-39%) of respondents for a RCT of three years duration; and by 5 (3%, CI 1-5%), 37 (19%, CI 14-25%) and 59 (30%, CI 24-36%) of respondents respectively for a RCT of six years duration. Postnatal wards are expected to be the most successful recruitment domain for the proposed RCT, likely a reflection of the face-to-face direct recruitment by researchers. It appears feasible to recruit into the proposed RCT using three large New Zealand tertiary hospitals.

  1. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial

    Science.gov (United States)

    Thomas, James S.; France, Christopher R.; Applegate, Megan E.; Leitkam, Samuel T.; Walkowski, Stevan

    2016-01-01

    Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is both entertaining and distracting. We recruited 52 participants (48% female) with CLBP and high fear of movement and randomized them to either a game group (n=26) or a control group (n=26). All participants completed a pregame baseline and a follow up assessment (4–6 days later) of lumbar spine motion and expectations of pain and harm during standardized reaches to high (easier), middle, and low (hardest to reach) targets. For three consecutive days, participants in the game group completed 15 minutes of virtual dodgeball between baseline and follow up. For the standardized reaching tests, there were no significant effects of group on changes in lumbar spine flexion, expected pain, or expected harm. However, virtual dodgeball was effective at increasing lumbar flexion within and across gameplay sessions. Participants reported strong positive endorsement of the game, no increases in medication use, pain, or disability, and no adverse events. Although these findings indicate that very brief exposure to this game did not translate to significant changes outside the game environment, this was not surprising given that graded exposure therapy for fear of movement among individuals with low back pain typically last 8–12 sessions. Given the demonstration of safety, feasibility and ability to encourage lumbar flexion within gameplay, these findings provide support for a clinical trial wherein the treatment dose is more consistent with traditional graded-exposure approaches to CLBP. PMID:27616607

  2. A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

    Energy Technology Data Exchange (ETDEWEB)

    Dragun, Anthony E., E-mail: aedrag01@louisville.edu [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Quillo, Amy R. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Riley, Elizabeth C. [Department of Medical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Roberts, Teresa L.; Hunter, Allison M. [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Rai, Shesh N. [Department of Biostatistics and Epidemiology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Callender, Glenda G. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Jain, Dharamvir [Department of Medical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); McMasters, Kelly M. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Spanos, William J. [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States)

    2013-03-01

    Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity—pain requiring a course of narcotic analgesics—was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.

  3. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial

    OpenAIRE

    Reynolds, Rebecca M.; Denison, Fiona C.; Juszczak, Ed; Bell, Jennifer L.; Penneycard, Jessica; Strachan, Mark W.J.; Lindsay, Robert S; Alexander , Claire I; Love, Corinne D. B.; Whyte, Sonia; Mackenzie, Fiona; Stenson, Ben; Norman, Jane E.

    2017-01-01

    Background Metformin is widely used to treat gestational diabetes (GDM), but many women remain hyperglycaemic and require additional therapy. We aimed to determine recruitment rate and participant throughput in a randomised trial of glibenclamide compared with standard therapy insulin (added to maximum tolerated metformin) for treatment of GDM. Methods We conducted an open label feasibility study in 5 UK antenatal clinics among pregnant women 16 to 36 weeks’ gestation with metformin-treated G...

  4. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial

    OpenAIRE

    Reynolds, RM; Denison, FC; Juszczak, ER; Bell, JL; Penneycard, J; Strachan, MWJ; Lindsay, RS; Alexander CI,; Love, CDB; Whyte, S; Mackenzie, F; Stenson, B; Norman, JE

    2017-01-01

    Background: Metformin is widely used to treat gestational diabetes (GDM), but many women remain hyperglycaemic and require additional therapy. We aimed to determine recruitment rate and participant throughput in a randomised trial of glibenclamide compared with standard therapy insulin (added to maximum tolerated metformin) for treatment of GDM. Methods: We conducted an open label feasibility study in 5 UK antenatal clinics among pregnant women 16 to 36 weeks’ gestation with metformin-trea...

  5. A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia

    OpenAIRE

    Wesson, Jacqueline; Clemson, Lindy; Brodaty, Henry; Lord, Stephen; Taylor, Morag; Gitlin, Laura; Close, Jacqueline

    2013-01-01

    Background People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. Methods A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant?s individual cognitive levels and implemented as a carer-supported interventi...

  6. The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression.

    Science.gov (United States)

    Lloyd-Evans, Brynmor; Bone, Jessica K; Pinfold, Vanessa; Lewis, Glyn; Billings, Jo; Frerichs, Johanna; Fullarton, Kate; Jones, Rebecca; Johnson, Sonia

    2017-10-23

    Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression. People with mental health problems are particularly vulnerable to loneliness and, for those with anxiety or depression, loneliness is associated with poorer outcomes. Interventions which support people to utilise existing networks and access new social contact are advocated in policy but there is little evidence regarding their effectiveness. People with mental health problems have potential to benefit from interventions to reduce loneliness, but evidence is needed regarding their feasibility, acceptability and outcomes. An intervention to reduce loneliness for people with anxiety or depression treated in secondary mental health services was developed for this study, which will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial. In this feasibility trial, 40 participants with anxiety or depression will be recruited through two secondary mental health services in London and randomised to an intervention (n = 30) or control group (n = 10). The control group will receive standard care and written information about local community resources. The coproduced intervention, developed in this study, includes up to ten sessions with a 'Community Navigator' over a 6-month period. Community Navigators will work with people individually to increase involvement in social activities, with the aim of reducing feelings of loneliness. Data will be collected at baseline and at 6-month follow-up - the end of the intervention period. The acceptability of the intervention and feasibility of participant recruitment and retention will be assessed. Potential primary and secondary outcomes for a future definitive trial will be completed to assess response and completeness, including measures of loneliness, depression and anxiety. Qualitative interviews with participants, staff and other

  7. A group intervention to reduce intimate partner violence among female drug users. Results from a randomized controlled pilot trial in a community substance-abuse center.

    Science.gov (United States)

    Tirado-Muñoz, Judit; Gilchrist, Gail; Lligoña, Eva; Gilbert, Louisa; Torrens, Marta

    2015-09-15

    A greater proportion of drug dependent women are victims of intimate partner violence (IPV) than women in the general population; however, few interventions have been developed to reduce IPV among drug dependent women. An adapted version of the Women's Wellness Treatment, to address IPV and depressive symptoms, was piloted in a randomized controlled trial conducted in outpatient treatment program in Barcelona, Spain among 14 women receiving outpatient treatment for a drug use disorder who screened positive for IPV in the previous month. Participants were randomly assigned to receive the 10 session cognitive behavioral therapy (IPaViT-CBT) group intervention or treatment as usual. The frequency of IPV, depressive symptoms, substance use, quality of life and health status were assessed at baseline and 1, 3 and 12 months post intervention. Intention to treat analysis was performed. Moderate effects for the intervention were found in reducing psychological maltreatment, increasing assertiveness of IPV and reducing aggressiveness in the partner relationship, and in reducing the frequency of drinking up to 3 months post intervention. The intervention did not significantly reduce the likelihood of any IPV, depressive symptoms, quality of life or self-reported health status, up to 12-months post intervention. This pilot trial suggests some initial support for the 10-session CBT group intervention among IPV victims who received treatment for drug use. Study findings indicate that it is feasible to deliver the intervention in a community substance abuse center. An adequately powered trial is required to replicate these results.

  8. Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial).

    Science.gov (United States)

    Everitt, Hazel A; Moss-Morris, Rona E; Sibelli, Alice; Tapp, Laura; Coleman, Nicholas S; Yardley, Lucy; Smith, Peter W; Little, Paul S

    2010-11-18

    IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of

  9. Feasibility and Safety of Flexible Bronchoscopy Performed Via Tracheal Tubes in Patients With Tracheostomies: A Retrospective, Single-Center Experience.

    Science.gov (United States)

    Ferrer, Gustavo; Lee, Chi Chan; Shaharyar, Sameer; Perez, Osman; Moor, Molly; Gomez, Frank; Tse, Fanny; Feiz, Hamid; Danckers, Mauricio

    2017-10-01

    Flexible bronchoscopy (FB) is commonly performed to assess, diagnose, and treat patients with respiratory disease, and is typically performed via transnasal or transoral approaches. FB can be performed via tracheal tubes in patients with tracheostomies; however, the safety and technical feasibility has not been established. The present study evaluates the safety and feasibility of performing FB via tracheal tubes. A total of 45 patients underwent 56 procedures involving FB via tracheal tubes at a single institution from November 2013 to November 2014 and were included in this retrospective case series. Patients had a median age of 68 years (interquartile range, 56 to 82.5), and 51% were female. Most patients had 2 comorbidities (interquartile range, 1 to 3), with the most common being hypertension, diabetes mellitus, and chronic kidney disease. Upper airway obstruction was the primary indication for bronchoscopy in 40% of patients. Fifty-three percent of patients had a Shiley tube #6, [internal cannula diameter (ICD) of 6.5 mm]; tracheal tubes in the remaining patients ranged from Shiley #4 (ICD, 5.5 mm) to Shiley #8 (ICD, 8.5 mm). One patient did not complete the procedure due to severe hypertension (intraprocedural systolic blood pressure >180 mm Hg). During FB, no patients experienced cardiorespiratory arrest, arrhythmia, bleeding, or desaturation that required resuscitation. Eleven patients had a mucus plug leading to atelectasis during bronchoscopy, and 8 of these had a postprocedural chest x-ray finding of lung reexpansion. FB via tracheal tubes is a technically feasible and safe procedure that does not compromise patient oxygenation.

  10. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': A feasibility study PEACH Trial: Prescribed exercise after chemotherapy

    Directory of Open Access Journals (Sweden)

    Guinan Emer

    2010-02-01

    Full Text Available Abstract Background Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. Methods/design The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks, at the end of the intervention (8 weeks, and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. Discussion This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy. Trial Registration NCT01030887

  11. Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.

    Science.gov (United States)

    Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H

    2016-10-01

    Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.

  12. Feasibility and effectiveness of a web-based positive psychology program for youth mental health: randomized controlled trial.

    Science.gov (United States)

    Manicavasagar, Vijaya; Horswood, Deserae; Burckhardt, Rowan; Lum, Alistair; Hadzi-Pavlovic, Dusan; Parker, Gordon

    2014-06-04

    Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help. While it is increasingly recognized that prevention is better than cure, most youth prevention programs have utilized interventions based on clinical treatments (eg, cognitive behavioral therapy) with inconsistent results. This study explores the feasibility of the online delivery of a youth positive psychology program, Bite Back, to improve the well-being and mental health outcomes of Australian youth. Further aims were to examine rates of adherence and attrition, and to investigate the program's acceptability. Participants (N=235) aged 12-18 years were randomly assigned to either of two conditions: Bite Back (n=120) or control websites (n=115). The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains; the control condition was assigned to neutral entertainment-based websites that contained no psychology information. Participants in both groups were instructed to use their allocated website for 6 consecutive weeks. Participants were assessed pre- and postintervention on the Depression Anxiety Stress Scale-Short form (DASS-21) and the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). Of the 235 randomized participants, 154 (65.5%) completed baseline and post measures after 6 weeks. Completers and dropouts were equivalent in demographics, the SWEMWBS, and the depression and anxiety subscales of the DASS-21, but dropouts reported significantly higher levels of stress than completers. There were no differences between the Bite Back and control conditions at baseline on demographic variables, DASS-21, or SWEMWBS scores. Qualitative data indicated that 49 of 61 Bite Back users (79%) reported positive experiences using the website and 55 (89%) agreed they would continue to use it after study completion. Compared to the

  13. The TRENDY multi-center randomized trial on hepatocellular carcinoma - Trial QA including automated treatment planning and benchmark-case results

    NARCIS (Netherlands)

    Habraken, S.J.M.; Sharfo, A.W.M.; Buijsen, J.; Verbakel, W.; Haasbeek, C.J.A.; Ollers, M.C.; Westerveld, H.; Wieringen, N. van; Reerink, O.; Seravalli, E.; Braam, P.M.; Wendling, M.; Lacornerie, T.; Mirabel, X.; Weytjens, R.; Depuydt, L.; Tanadini-Lang, S.; Riesterer, O.; Haustermans, K.; Depuydt, T.; Dwarkasing, R.S.; Willemssen, F.; Heijmen, B.J.M.; Romero, A.

    2017-01-01

    BACKGROUND AND PURPOSE: The TRENDY trial is an international multi-center phase-II study, randomizing hepatocellular carcinoma (HCC) patients between transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) with a target dose of 48-54Gy in six fractions. The radiotherapy

  14. The TRENDY multi-center randomized trial on hepatocellular carcinoma - Trial QA including automated treatment planning and benchmark-case results

    NARCIS (Netherlands)

    Habraken, Steven J. M.; Sharfo, Abdul Wahab M.; Buijsen, Jeroen; Verbakel, Wilko F. A. R.; Haasbeek, Cornelis J. A.; Öllers, Michel C.; Westerveld, Henrike; van Wieringen, Niek; Reerink, Onne; Seravalli, Enrica; Braam, Pètra M.; Wendling, Markus; Lacornerie, Thomas; Mirabel, Xavier; Weytjens, Reinhilde; Depuydt, Lieselotte; Tanadini-Lang, Stephanie; Riesterer, Oliver; Haustermans, Karin; Depuydt, Tom; Dwarkasing, Roy S.; Willemssen, François E. J. A.; Heijmen, Ben J. M.; Méndez Romero, Alejandra

    2017-01-01

    Background and purpose: The TRENDY trial is an international multi-center phase-II study, randomizing hepatocellular carcinoma (HCC) patients between transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) with a target dose of 48-54 Gy in six fractions. The

  15. Family-centered brief intervention for reducing obesity and cardiovascular disease risk: A randomized controlled trial.

    Science.gov (United States)

    Duncan, Scott; Goodyear-Smith, Felicity; McPhee, Julia; Zinn, Caryn; Grøntved, Anders; Schofield, Grant

    2016-11-01

    To assess the effects of a family-centered, physical activity and nutrition "brief" intervention (time-limited contact) on body weight and related health outcomes in primary health care patients with an elevated 5-year cardiovascular disease (CVD) risk. This study implemented a cluster randomized controlled trial design with two treatment conditions: a CVD risk assessment and one-time consultation ("usual care" control) and a CVD risk assessment and up to five home sessions that aimed to reduce obesity by encouraging physical activity and healthy eating (intervention). Three hundred and twenty patients aged 35 to 65 years from 16 primary health care clinics in Auckland, New Zealand, participated in the study. Intervention effects on BMI, waist circumference, blood pressure, blood cholesterol, triglycerides, 5-year CVD risk, physical activity, and dietary patterns were assessed using generalized linear mixed models. When compared with the control group, the intervention resulted in a significant but relatively modest decrease in BMI between baseline and the 12-month follow-up (-0.633 kg m(-2) , Padj  = 0.048). Significant decreases were also observed for total cholesterol at 4 and 12 months, the total cholesterol to high-density lipoprotein cholesterol ratio at 4 months, 5-year CVD risk at 4 months, and fast food consumption at 12 months. Our findings show that a family-centered brief intervention targeting physical activity and nutrition can generate slightly better obesity-related health outcomes than usual care alone. © 2016 The Obesity Society.

  16. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

    Science.gov (United States)

    Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

    2016-06-01

    Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Pilot parallel three-arm randomised controlled trial nested within feasibility work. Two UK NHS departments of upper gastrointestinal surgery. Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing

  17. Efficacy of brief motivational interviewing to improve adherence to inhaled corticosteroids among adult asthmatics: results from a randomized controlled pilot feasibility trial

    Directory of Open Access Journals (Sweden)

    Lavoie KL

    2014-11-01

    Full Text Available Kim L Lavoie,1–3 Gregory Moullec,1,2,4 Catherine Lemiere,2 Lucie Blais,2 Manon Labrecque,2 Marie-France Beauchesne,2 Veronique Pepin,2,4 André Cartier,2 Simon L Bacon1,2,41Montreal Behavioural Medicine Centre, 2Research Centre, Hôpital du Sacré-Cœur de Montréal – A University of Montreal Affiliated Hospital, Montréal, 3Department of Psychology, University of Quebec at Montreal (UQAM, Succursale Center-Ville, Montreal, 4Department of Exercise Science, Concordia University, Montreal, Quebec, CanadaPurpose: Daily adherence to inhaled corticosteroid (ICS regimens is one of the most important factors linked to achieving optimal asthma control. Motivational interviewing (MI is a client-centered communication style that focuses on enhancing intrinsic motivation to engage in appropriate self-management behaviors. MI has been shown to improve a variety of health behaviors including medication adherence in other disorders, but its efficacy for the improvement of ICS adherence in asthmatics has yet to be examined. This pilot “proof of concept” trial assessed the feasibility of MI to improve daily ICS adherence and asthma control levels in adult asthmatics.Methods: Fifty-four poorly controlled (Asthma Control Questionnaire [ACQ] score ≥1.5, highly nonadherent (filled <50% of ICS medication in the last year adult asthmatics were recruited from the outpatient asthma clinic of a university-affiliated hospital. Participants underwent baseline assessments and were randomly assigned to MI (3×30 minutes sessions within a 6-week period, n=26 or a usual care (UC control group (n=28. ICS adherence (% pharmacy refills and asthma control (ACQ, Asthma Control Test [ACT] were measured at 6 and 12 months postintervention. Mixed model repeated measure analyses for both intent-to-treat and per-protocol were used. Results were adjusted for a priori-defined covariates including baseline adherence. Patients in the MI group also reported their impressions of

  18. Feasibility and acceptability of two incentive-based implementation strategies for mental health therapists implementing cognitive-behavioral therapy: a pilot study to inform a randomized controlled trial.

    Science.gov (United States)

    Beidas, Rinad S; Becker-Haimes, Emily M; Adams, Danielle R; Skriner, Laura; Stewart, Rebecca E; Wolk, Courtney Benjamin; Buttenheim, Alison M; Williams, Nathaniel J; Inacker, Patricia; Richey, Elizabeth; Marcus, Steven C

    2017-12-15

    Informed by our prior work indicating that therapists do not feel recognized or rewarded for implementation of evidence-based practices, we tested the feasibility and acceptability of two incentive-based implementation strategies that seek to improve therapist adherence to cognitive-behavioral therapy for youth, an evidence-based practice. This study was conducted over 6 weeks in two community mental health agencies with therapists (n = 11) and leaders (n = 4). Therapists were randomized to receive either a financial or social incentive if they achieved a predetermined criterion on adherence to cognitive-behavioral therapy. In the first intervention period (block 1; 2 weeks), therapists received the reward they were initially randomized to if they achieved criterion. In the second intervention period (block 2; 2 weeks), therapists received both rewards if they achieved criterion. Therapists recorded 41 sessions across 15 unique clients over the project period. Primary outcomes included feasibility and acceptability. Feasibility was assessed quantitatively. Fifteen semi-structured interviews were conducted with therapists and leaders to assess acceptability. Difference in therapist adherence by condition was examined as an exploratory outcome. Adherence ratings were ascertained using an established and validated observational coding system of cognitive-behavioral therapy. Both implementation strategies were feasible and acceptable-however, modifications to study design for the larger trial will be necessary based on participant feedback. With respect to our exploratory analysis, we found a trend suggesting the financial reward may have had a more robust effect on therapist adherence than the social reward. Incentive-based implementation strategies can be feasibly administered in community mental health agencies with good acceptability, although iterative pilot work is essential. Larger, fully powered trials are needed to compare the effectiveness of

  19. Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA).

    Science.gov (United States)

    Hanley, Janet; Fairbrother, Peter; Krishan, Ashma; McCloughan, Lucy; Padfield, Paul; Paterson, Mary; Pinnock, Hilary; Sheikh, Aziz; Sudlow, Cathie; Todd, Allison; McKinstry, Brian

    2015-03-25

    Good blood pressure (BP) control reduces the risk of recurrence of stroke/transient ischaemic attack (TIA). Although there is strong evidence that BP telemonitoring helps achieve good control, none of the major trials have considered the effectiveness in stroke/TIA survivors. We therefore conducted a feasibility study for a trial of BP telemonitoring for stroke/TIA survivors with uncontrolled BP in primary care. Phase 1 was a pilot trial involving 55 patients stratified by stroke/TIA randomised 3:1 to BP telemonitoring for 6 months or usual care. Phase 2 was a qualitative evaluation and comprised semi-structured interviews with 16 trial participants who received telemonitoring and 3 focus groups with 23 members of stroke support groups and 7 carers. Overall, 125 patients (60 stroke patients, 65 TIA patients) were approached and 55 (44%) patients were randomised including 27 stroke patients and 28 TIA patients. Fifty-two participants (95%) attended the 6-month follow-up appointment, but one declined the second daytime ambulatory blood pressure monitoring (ABPM) measurement resulting in a 93% completion rate for ABPM - the proposed primary outcome measure for a full trial. Adherence to telemonitoring was good; of the 40 participants who were telemonitoring, 38 continued to provide readings throughout the 6 months. There was a mean reduction of 10.1 mmHg in systolic ABPM in the telemonitoring group compared with 3.8 mmHg in the control group, which suggested the potential for a substantial effect from telemonitoring. Our qualitative analysis found that many stroke patients were concerned about their BP and telemonitoring increased their engagement, was easy, convenient and reassuring. A full-scale trial is feasible, likely to recruit well and have good rates of compliance and follow-up. ISRCTN61528726 15/12/2011.

  20. Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

    Science.gov (United States)

    Knirsch, Charles; Alemayehu, Demissie; Botgros, Radu; Comic-Savic, Sabrina; Friedland, David; Holland, Thomas L; Merchant, Kunal; Noel, Gary J; Pelfrene, Eric; Reith, Christina; Santiago, Jonas; Tiernan, Rosemary; Tenearts, Pamela; Goldsack, Jennifer C; Fowler, Vance G

    2016-08-15

    The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of

  1. Evaluating feasibility and acceptability of a local psycho-educational intervention for pregnant women with common mental problems affected by armed conflict in Swat, Pakistan: A parallel randomized controlled feasibility trial.

    Science.gov (United States)

    Khan, Muhammad Naseem; Dherani, Mukesh; Chiumento, Anna; Atif, Najia; Bristow, Katie; Sikander, Siham; Rahman, Atif

    2017-12-01

    The current research was conducted in the Swat valley, where widespread conflict and militancy had been experienced prior to the field activities. The aim of this trial was to evaluate the feasibility and acceptability of a locally developed psycho-educational intervention. This mixed-methods study incorporated a quantitative and qualitative component. For the quantitative component, trial participants were identified from a cross-sectional study conducted in the earlier phase of the research, with Self-Reporting Questionnaire (SRQ) score of ≥9. Participants with suicidal ideation, severe mental or medical illness, recently given birth or living with another woman with an SRQ score of 9 or above were excluded. Participants fulfilling eligibility were randomized on a 1:1 allocation ratio using simple randomization to the psycho-educational intervention or routine care arm. The intervention arm received two psycho-educational sessions at their homes delivered by local community health worker from the study area. The primary outcome was help-seeking for psychological distress, measured by a semi-structured interview by a researcher blind to the allocation status at 2 months post-intervention. Secondary outcomes include psychological distress and social support measured by SRQ and Multidimensional Scale of Perceived Social Support (MSPSS), respectively, at 2 months post-intervention. Intervention acceptability was explored through in-depth interviews. Local community health workers with no mental health experience successfully delivered the psycho-educational sessions in the community. The uptake of intervention was good and the intervention was taken well by the families and the community health workers. The outcome evaluation was not powered; however, more women sought assistance for their distress from their community health workers in the intervention arm, compared to women in the control arm. This trial showed good acceptance and feasible delivery of a

  2. "FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

    2016-04-16

    Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

  3. Mindfulness-Based Crisis Interventions for patients with psychotic symptoms on acute psychiatric wards (amBITION study): Protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Jacobsen, Pamela; Peters, Emmanuelle; Chadwick, Paul

    2016-12-01

    Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. People often need to go into hospital when they have a mental health crisis due to overwhelming distressing psychotic symptoms, such as hearing voices (hallucinations) or experiencing unusual beliefs (delusions). Brief talking therapies may be helpful for people during an acute inpatient admission as an adjunct to medication in reducing re-admission rates, and despite promising findings from trials in the USA, there have not yet been any clinical trials on this kind of intervention within NHS settings. The amBITION study is a feasibility randomised controlled trial (RCT) of a manualised brief talking therapy (Mindfulness-Based Crisis Intervention; MBCI). Inpatients on acute psychiatric wards are eligible for the study if they report at least one positive psychotic symptom, and are willing and able to engage in a talking therapy. In addition to treatment as usual (TAU), participants will be randomly allocated to receive either MBCI or a control intervention (Social Activity Therapy; SAT) which will be based on doing activities on the ward with the therapist. The primary objective of the study is to find out whether it is possible to carry out this kind of trial successfully within UK inpatient settings and to find out whether patients and staff find it an acceptable intervention. The secondary objective is to collect pilot data on primary and secondary outcome measures, including re-admission rates at 6 month follow-up. This will provide information on the appropriateness of re-admission as the primary outcome measure for future efficacy trials, as well as data on the acceptability and utility of the clinical self-report measures. The results of the feasibility trial will indicate whether a subsequent efficacy pilot trial is warranted, and if so, will provide vital information for the planning

  4. Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA).

    Science.gov (United States)

    Jolly, Kate; Ingram, Jenny; Clarke, Joanne; Johnson, Debbie; Trickey, Heather; Thomson, Gill; Dombrowski, Stephan U; Sitch, Alice; Dykes, Fiona; Feltham, Max G; Darwent, Kirsty; MacArthur, Christine; Roberts, Tracy; Hoddinott, Pat

    2018-01-23

    Breast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman's feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care. A two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper-women interactions to assess intervention fidelity. Study results will

  5. Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

    Science.gov (United States)

    van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

    2016-07-26

    Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

  6. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial.

    Science.gov (United States)

    Beaudreuil, Johann; Lasbleiz, Sandra; Richette, Pascal; Seguin, Gérard; Rastel, Christine; Aout, Mounir; Vicaut, Eric; Cohen-Solal, Martine; Lioté, Frédéric; de Vernejoul, Marie-Christine; Bardin, Thomas; Orcel, Philippe

    2011-09-01

    Treatment for degenerative rotator cuff disease of the shoulder includes physiotherapy. Dynamic humeral centering (DHC) aims at preventing subacromial impingement, which contributes to the disease. The goal of this study was to assess the effectiveness of DHC. 69 patients with shoulder pain and impingement syndrome were prospectively included in a single-centre randomised trial with a 12-month follow-up. Patients and assessor were blinded to the study hypothesis and treatment, respectively. DHC and non-specific mobilisation as control were performed for 6 weeks, in 15 supervised individual outpatient sessions, and patients performed daily home exercises. The planned primary outcome was the Constant score including subscores for pain, activity, mobility and strength at 3 months. Secondary outcomes were the Constant score and subscores at 12 months, and medication use for pain at 3 and 12 months. The DHC group did not differ from the control group in the total Constant score at 3 months. However, the DHC group showed a higher Constant subscore for pain (12.2 (SD 2.8) vs 9.9 (2.9), least square means difference 2.1, 95% CI 0.7 to 3.5, p=0.004). At 3 months, the DHC group also showed a higher rate of no medication use (96.7% vs 71%, proportional difference 25.7, 95% CI 3.7 to 51.9, p=0.012). There was no other intergroup difference. There was no difference in the total Constant score between DHC and controls. However, pain was improved at 3 months after DHC. The differences found in subscores for pain should be explored in future studies. Trial registration clinicaltrials.gov Identifier: NCT 01022775.

  7. Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.

    Science.gov (United States)

    Sereda, Magdalena; Davies, Jeff; Hall, Deborah A

    2017-04-01

    This report considers feasibility of conducting a UK trial of combination devices for tinnitus, using data from the study which evaluated different listener programmes available within the pre-market version of Oticon Alta with Tinnitus Sound Generator. Open and closed questions addressed the following feasibility issues: (1) Participant recruitment; (2) Device acceptability; (3) Programme preferences in different self-nominated listening situations; (4) Usability; (5) Compliance; (6) Adverse events. Eight current combination hearing aid users (all males) aged between 62-72 years (mean age 67.25 years, SD = 3.8). All eight participants reported the physical aspects and noise options on the experimental device to be acceptable. Programmes with amplification and masking features were equally preferred over the basic amplification-only programme. Individual preferences for the different programme options varied widely, both across participants and across listening situations. A set of recommendations for future trials were formulated which calls for more "real world" trial design rather than tightly controlling the fitting procedure.

  8. Standardized ultrasound evaluation of carotid stenosis for clinical trials: University of Washington Ultrasound Reading Center

    Directory of Open Access Journals (Sweden)

    Beach Kirk W

    2010-09-01

    Full Text Available Abstract Introduction Serial monitoring of patients participating in clinical trials of carotid artery therapy requires noninvasive precision methods that are inexpensive, safe and widely available. Noninvasive ultrasonic duplex Doppler velocimetry provides a precision method that can be used for recruitment qualification, pre-treatment classification and post treatment surveillance for remodeling and restenosis. The University of Washington Ultrasound Reading Center (UWURC provides a uniform examination protocol and interpretation of duplex Doppler velocity measurements. Methods Doppler waveforms from 6 locations along the common carotid and internal carotid artery path to the brain plus the external carotid and vertebral arteries on each side using a Doppler examination angle of 60 degrees are evaluated. The UWURC verifies all measurements against the images and waveforms for the database, which includes pre-procedure, post-procedure and annual follow-up examinations. Doppler angle alignment errors greater than 3 degrees and Doppler velocity measurement errors greater than 0.05 m/s are corrected. Results Angle adjusted Doppler velocity measurements produce higher values when higher Doppler examination angles are used. The definition of peak systolic velocity varies between examiners when spectral broadening due to turbulence is present. Examples of measurements are shown. Discussion Although ultrasonic duplex Doppler methods are widely used in carotid artery diagnosis, there is disagreement about how the examinations should be performed and how the results should be validated. In clinical trails, a centralized reading center can unify the methods. Because the goals of research examinations are different from those of clinical examinations, screening and diagnostic clinical examinations may require fewer velocity measurements.

  9. Standardized ultrasound evaluation of carotid stenosis for clinical trials: University of Washington Ultrasound Reading Center.

    Science.gov (United States)

    Beach, Kirk W; Bergelin, Robert O; Leotta, Daniel F; Primozich, Jean F; Sevareid, P Max; Stutzman, Edward T; Zierler, R Eugene

    2010-09-07

    Serial monitoring of patients participating in clinical trials of carotid artery therapy requires noninvasive precision methods that are inexpensive, safe and widely available. Noninvasive ultrasonic duplex Doppler velocimetry provides a precision method that can be used for recruitment qualification, pre-treatment classification and post treatment surveillance for remodeling and restenosis. The University of Washington Ultrasound Reading Center (UWURC) provides a uniform examination protocol and interpretation of duplex Doppler velocity measurements. Doppler waveforms from 6 locations along the common carotid and internal carotid artery path to the brain plus the external carotid and vertebral arteries on each side using a Doppler examination angle of 60 degrees are evaluated. The UWURC verifies all measurements against the images and waveforms for the database, which includes pre-procedure, post-procedure and annual follow-up examinations. Doppler angle alignment errors greater than 3 degrees and Doppler velocity measurement errors greater than 0.05 m/s are corrected. Angle adjusted Doppler velocity measurements produce higher values when higher Doppler examination angles are used. The definition of peak systolic velocity varies between examiners when spectral broadening due to turbulence is present. Examples of measurements are shown. Although ultrasonic duplex Doppler methods are widely used in carotid artery diagnosis, there is disagreement about how the examinations should be performed and how the results should be validated. In clinical trails, a centralized reading center can unify the methods. Because the goals of research examinations are different from those of clinical examinations, screening and diagnostic clinical examinations may require fewer velocity measurements.

  10. A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia

    Science.gov (United States)

    2013-01-01

    Background People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. Methods A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant’s individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Results Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. Conclusions The pilot study was feasible and acceptable to people with mild dementia and their

  11. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

    Energy Technology Data Exchange (ETDEWEB)

    Michel, Patrik [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Centre Hospitalier Universitaire Vaudois and University of Lausanne, Neurology Service, Lausanne (Switzerland); Ntaios, George; Reichhart, Marc [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Schindler, Christian [Center Hospitalier Universitaire Vaudois and University of Lausanne, Pharmacy Department, Lausanne (Switzerland); Bogousslavsky, Julien [Genolier Swiss Medical Network, Glion (Switzerland); Maeder, Philip; Meuli, Reto [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Radiology, Lausanne (Switzerland); Wintermark, Max [University of Virginia, Department of Radiology, Division of Neuroradiology, Charlottesville, VA (United States)

    2012-06-15

    Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm{sup 3} in the treatment arm and 29 (8-105) cm{sup 3} in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

  12. Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Ouellette, Adam Louis; Liston, Matthew B; Chang, Wei-Ju; Walton, David M; Wand, Benedict Martin; Schabrun, Siobhan M

    2017-08-21

    Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. ACTRN12616000624482. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers.

    Science.gov (United States)

    Garcia, Raul I; Tiwari, Tamanna; Ramos-Gomez, Francisco; Heaton, Brenda; Orozco, Mario; Rasmussen, Margaret; Braun, Patricia; Henshaw, Michelle; Borrelli, Belinda; Albino, Judith; Diamond, Courtney; Gebel, Christina; Batliner, Terrence S; Barker, Judith C; Gregorich, Steven; Gansky, Stuart A

    2017-12-01

    To identify successful strategies for retention of participants in multiyear, community-based randomized controlled trials (RCTs) aiming to reduce early childhood caries in health disparities populations from diverse racial/ethnic backgrounds and across diverse geographic settings. Four RCTs conducted by the Early Childhood Caries Collaborating Centers (EC4), an initiative of the National Institute of Dental and Craniofacial Research, systematically collected information on the success of various strategies implemented to promote participant retention in each RCT. The observational findings from this case series of four RCTs were tabulated and the strategies rated by study staff. Participant retention at 12 months of follow-up ranged from 52.8 percent to 91.7 percent, and at 24 months ranged from 53.6 percent to 85.9, across the four RCTs. For the three RCTs that had a 36-month follow-up, retention ranged from 53.6 percent to 85.1 percent. Effectiveness of different participant retention strategies varied widely across the RCTs. Findings from this case series study may help to guide the design of future RCTs to maximize retention of study participants and yield needed data on effective interventions to reduce oral health disparities. © 2016 American Association of Public Health Dentistry.

  14. A Family-Centered Rounds Checklist, Family Engagement, and Patient Safety: A Randomized Trial.

    Science.gov (United States)

    Cox, Elizabeth D; Jacobsohn, Gwen C; Rajamanickam, Victoria P; Carayon, Pascale; Kelly, Michelle M; Wetterneck, Tosha B; Rathouz, Paul J; Brown, Roger L

    2017-05-01

    Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs' benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children's Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff's communication openness and safety of handoffs and transitions. The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. Copyright © 2017 by the American Academy of Pediatrics.

  15. Parents Working Together: development and feasibility trial of a workplace-based program for parents that incorporates general parenting and health behaviour messages

    Directory of Open Access Journals (Sweden)

    L. Wilson

    2016-11-01

    Full Text Available Abstract Background Parenting programs integrating general parenting and health behaviour messaging may be an effective childhood obesity prevention strategy. The current study explored workplaces as an alternate setting to deliver parenting programs. Methods This study involved two phases. The objective of the first phase was to explore interest in and preferred delivery mode of a workplace program that addresses general parenting and health behaviours. The objective of the second phase was to adapt and test the feasibility and acceptability of a pre-existing program that has been successfully run in community settings for parents in their workplace. To achieve the first objective, we conducted 9 individual or small group qualitative interviews with 11 workplace representatives involved in employee wellness/wellness programming from 8 different organizations across Southwestern Ontario. To achieve the second objective, we adapted a pre-existing program incorporating workplace representatives’ suggestions to create Parents Working Together (PWT. We then tested the program using a pre/post uncontrolled feasibility trial with 9 employees of a large manufacturing company located in Guelph, Ontario. Results Results from the qualitative phase showed that a workplace parenting program that addresses general parenting and health behaviour messages is of interest to workplaces. Results from the feasibility trial suggest that PWT is feasible and well received by participants; attendance rates were high with 89 % of the participants attending 5 or more sessions and 44 % attending all 7 sessions offered. All participants stated they would recommend the program to co-workers. Just over half of our parent participants were male (55.6 %, which is a unique finding as the majority of existing parenting programs engage primarily mothers. Impact evaluation results suggest that changes in children’s and parents’ weight-related behaviours, as well as

  16. Parents Working Together: development and feasibility trial of a workplace-based program for parents that incorporates general parenting and health behaviour messages.

    Science.gov (United States)

    Wilson, L; Lero, Donna; Smofsky, Allan; Gross, Deborah; Haines, Jess

    2016-11-10

    Parenting programs integrating general parenting and health behaviour messaging may be an effective childhood obesity prevention strategy. The current study explored workplaces as an alternate setting to deliver parenting programs. This study involved two phases. The objective of the first phase was to explore interest in and preferred delivery mode of a workplace program that addresses general parenting and health behaviours. The objective of the second phase was to adapt and test the feasibility and acceptability of a pre-existing program that has been successfully run in community settings for parents in their workplace. To achieve the first objective, we conducted 9 individual or small group qualitative interviews with 11 workplace representatives involved in employee wellness/wellness programming from 8 different organizations across Southwestern Ontario. To achieve the second objective, we adapted a pre-existing program incorporating workplace representatives' suggestions to create Parents Working Together (PWT). We then tested the program using a pre/post uncontrolled feasibility trial with 9 employees of a large manufacturing company located in Guelph, Ontario. Results from the qualitative phase showed that a workplace parenting program that addresses general parenting and health behaviour messages is of interest to workplaces. Results from the feasibility trial suggest that PWT is feasible and well received by participants; attendance rates were high with 89 % of the participants attending 5 or more sessions and 44 % attending all 7 sessions offered. All participants stated they would recommend the program to co-workers. Just over half of our parent participants were male (55.6 %), which is a unique finding as the majority of existing parenting programs engage primarily mothers. Impact evaluation results suggest that changes in children's and parents' weight-related behaviours, as well as parents' reports of family interfering with work were in the

  17. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

    Science.gov (United States)

    Bowrey, David J; Baker, Melanie; Halliday, Vanessa; Thomas, Anne L; Pulikottil-Jacob, Ruth; Smith, Karen; Morris, Tom; Ring, Arne

    2015-11-21

    Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients. Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences. Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking

  18. A Feasibility and Efficacy Randomized Controlled Trial of an Online Preventative Program for Childhood Obesity: Protocol for the EMPOWER Intervention.

    Science.gov (United States)

    Knowlden, Adam; Sharma, Manoj

    2012-06-21

    The home and family environment is a highly influential psychosocial antecedent of pediatric obesity. Implementation of conventional family- and home-based childhood obesity interventions is challenging for parents, often requiring them to attend multiple educational sessions. Attrition rates for traditional interventions are frequently high due to competing demands for parents' time. Under such constraints, an Internet-based intervention has the potential to modify determinants of childhood obesity while making judicious use of parents' time. Theory-based interventions offer many advantages over atheoretical interventions, including reduced intervention dosage, increased likelihood of behavioral change, and efficient resource allocation. Social cognitive theory (SCT) is a robust theoretical framework for addressing childhood obesity. SCT is a behavior change model rooted in reciprocal determinism, a causal paradigm that states that human functioning is the product of a dynamic interplay of behavioral, personal, and environmental factors. To evaluate the efficacy of the Enabling Mothers to Prevent Childhood Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER) program, an Internet-based, theory-driven intervention for preventing childhood overweight and obesity. The project goal is supported by two specific aims: (1) modification of four obesogenic protective factors related to childhood obesity (minutes engaged in physical activity, servings of fruits and vegetables consumed, servings of sugar-sweetened and sugar-free beverages consumed, and minutes engaged in screen time), and (2) reification of five maternal-mediated constructs of SCT (environment, expectations, emotional coping, self-control, and self-efficacy). We will recruit mothers with children ages 4 to 6 years from childcare centers and randomly assign them to either the theory-based (experimental) or knowledge-based (control) arm of the trial. Data for the intervention will be

  19. Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial

    Directory of Open Access Journals (Sweden)

    Shaun Treweek

    2010-03-01

    Conclusion An automated recruitment tool can support primary care trials in Scotland and has the potential to support recruitment in other jurisdictions. It offers a low-cost supplement to other trial recruitment methods and is likely to have a much lower screen failure rate than blanket approaches such as mailshots and newspaper campaigns.

  20. The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

    Science.gov (United States)

    Shimodera, Shinji; Kato, Tadashi; Sato, Hirotoshi; Miki, Kazuhira; Shinagawa, Yoshihiro; Kondo, Masaki; Fujita, Hirokazu; Morokuma, Ippei; Ikeda, Yoshio; Akechi, Tatsuo; Watanabe, Norio; Yamada, Mitsuhiko; Inagaki, Masatoshi; Yonemoto, Naohiro; Furukawa, Toshi A

    2012-06-08

    Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial's protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^)D] and would like to herein report an examination of the trial's feasibility and adherence among the first 100 participants. We examined the participants' characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^)D trial. Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8%) of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%). Of the 32 patients who had reached Week 25, 29 (90.5%) were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary. Given the satisfactory feasibility and adherence to the study protocol and the minor

  1. New developments in the conduct and management of multi-center trials

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I

    1995-01-01

    There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyzed...

  2. A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia.

    Science.gov (United States)

    Wesson, Jacqueline; Clemson, Lindy; Brodaty, Henry; Lord, Stephen; Taylor, Morag; Gitlin, Laura; Close, Jacqueline

    2013-09-03

    People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant's individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included

  3. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

    Directory of Open Access Journals (Sweden)

    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  4. NIA-funded Alzheimer centers are more efficient than commercial clinical recruitment sites for conducting secondary prevention trials of dementia.

    Science.gov (United States)

    Edland, Steven D; Emond, Jennifer A; Aisen, Paul S; Petersen, Ronald C

    2010-01-01

    Study participant dropout compromises clinical trials by reducing statistical power and potentially biasing findings. We use data from a trial of treatments to delay the progression of mild cognitive impairment to Alzheimer disease (AD) [NEJM 2005;352 (23):79 to 88] to determine predictors of study participant dropout and inform the design and implementation of future trials. Time to study discontinuation was modeled by proportional hazards regression with censoring at incident dementia or trial completion. Of 769 participants, 230 (30%) discontinued prematurely. Risk of dropout was higher among nonwhites [hazard ratio (HR) 2.1, P=0.0007], participants with less than college education (HR=1.6, P=0.02), participants with a Hamilton Depression score of 6 or more (HR=1.3, P=0.04), unmarried males (HR=2.1 relative to married males, P=0.003) and participants recruited by commercial clinical sites (HR=2.2 relative to participants recruited by NIA-funded AD research centers, PNIA-funded AD research center sites. Targeted retention efforts and utilization of academic sites could substantively improve the statistical power and validity of future clinical trials of cognitively impaired elderly.

  5. COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

    Science.gov (United States)

    Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

    2011-05-01

    Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

  6. A multicenter feasibility study of chronic graft-versus-host disease according to the National Institute of Health criteria: efforts to establish a Brazil-Seattle consortium as a platform for future collaboration in clinical trials

    Directory of Open Access Journals (Sweden)

    Afonso Celso Vigorito

    2011-01-01

    Full Text Available BACKGROUND: New criteria for the diagnosis and classification of chronic graft-versus-host disease were developed in 2005 for the purpose of clinical trials with a consensus sponsored by the National Institute of Health. OBJECTIVES: The aim of this study is to present the results of a multicenter pilot study performed by the Brazil-Seattle chronic graft-versus-host disease consortium to determine the feasibility of using these criteria in five Brazilian centers. METHODS: The study was performed after translation of the consensus criteria into Portuguese and training. A total of 34 patients with National Institute of Health chronic graft-versus-host disease were enrolled in the pilot study between June 2006 and May 2009. RESULTS: Of the 34 patients, 26 (76% met the criteria of overlap syndrome and eight (24% the classic subcategory. The overall severity of disease was moderate in 21 (62% and severe in 13 (38% patients. The median time from transplant to onset of chronic graft-versus-host disease was 5.9 months (Range: 3 - 16 months; the median time for the overlap syndrome subcategory was 5.9 months (Range: 3 - 10 months and for the classic subcategory, it was 7.3 months (Range: 3 - 16 months. At a median follow up of 16.5 months (Range: 4 - 39 months, overall survival was 75%. CONCLUSIONS: It was feasible to use the National Institute of Health consensus criteria for the diagnosis and scoring of chronic graft-versus-host disease in a Brazilian prospective multicenter study. More importantly, a collaborative hematopoietic cell transplantation network was established in Brazil offering new opportunities for future clinical trials in chronic graft-versus-host disease and in other areas of research involving hematopoietic stem cell transplantation.

  7. Feasibility of Using a Community-Supported Agriculture Program to Increase Access to and Intake of Vegetables among Federally Qualified Health Center Patients.

    Science.gov (United States)

    Izumi, Betty T; Higgins, Cesar E; Baron, Andrea; Ness, Sylvia J; Allan, Bryan; Barth, Elizabeth T; Smith, Teresa M; Pranian, Katy; Frank, Brian

    2017-11-21

    This study explored the feasibility of using a 23-week subsidized community-supported agriculture program to increase access to and intake of vegetables among Federally Qualified Health Center patients. Outcomes were measured using pre-post intervention surveys (n = 9). Process data were collected in post-intervention surveys and focus groups (n = 15). Most participants (77%) indicated that the program improved their health and all (100%) reported that they were eating a greater variety of vegetables because of their participation in the program. Three themes emerged from the focus groups: increased access to fresh and/or organic vegetables, improved diet quality, and the importance of social support during the program. Linking subsided community-supported agriculture programs with Federally Qualified Health Centers has the potential to increase access to and intake of vegetables among low-income patients. However, further research is needed with a larger sample size and a more robust study design. Copyright © 2017 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  8. Schwartz Center Rounds. A Staff Dialogue on Phase I Trials: Psychosocial Issues Faced by Patients, Their Families, and Caregivers.

    Science.gov (United States)

    Lintz; Penson; Chabner; Mack; Lynch

    1998-01-01

    Shortly before his death in 1995, Kenneth B. Schwartz, a cancer patient at Massachusetts General Hospital, founded The Kenneth B. Schwartz Center to be housed at Massachusetts General Hospital (MGH). He created this center to advance the hopes, goals, and ideas expressed in his article, "A Patient's Story," published in the July 16, 1995 issue of the Boston Globe Magazine. The Schwartz Center is a non-profit organization dedicated to strengthening the relationship between patients and caregivers and to supporting and advancing "compassionate health care delivery in which caregivers, patients and their families relate meaningfully to one another in a way that provides hope to the patient, support to caregivers and sustenance to the healing process." One of the Center's major projects is the sponsoring of the Schwartz Center Rounds, a monthly, multidisciplinary forum in which caregivers discuss a specific cancer patient and the important psychosocial issues faced by the patient, family and caregivers. The forum allows caregivers to reflect on their experiences with patients and to gain support and insight from fellow staff members. The following case discussion was addressed at the January 1998 Schwartz Center Rounds. In this article, the case will be presented, followed by verbatim dialogue from the rounds and a subsequent discussion of the relevant issues with emphasis on staff psychosocial issues. J.T. was a 43-year-old man who developed adenocarcinoma of the lung and was treated at MGH. He died while participating in a phase I trial, resulting in marked frustration and distress among his caregivers. Staff questioned whether cancer patients entering phase I trials and their families receive unbiased information about the possible risks and benefits of the trial. They were also concerned about whether or not patients and their families really understand the physical and emotional risks of a trial. Moreover, they addressed whether patients are presented with

  9. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    Science.gov (United States)

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

  10. The feasibility of clinical endpoint trials in HIV infection in the highly active antiretroviral treatment (HAART) era

    DEFF Research Database (Denmark)

    Mocroft, A; Neaton, J; Bebchuk, J

    2006-01-01

    the assumptions used in designing ESPRIT, a large randomized clinical trial assessing the clinical benefit of interleukin-2 treatment in patients with HIV infection, to use EuroSIDA to mimic the inclusion criterion of ESPRIT in order to compare the observed event rate in ESPRIT with the projected rate in Euro......BACKGROUND: Planning clinical-endpoint trials in patients with HIV remain difficult as long-term follow-up of many patients is required. Cohort studies of patients with HIV can provide key estimates of the likely disease progression, required sample size and follow-up. OBJECTIVES: To verify...... to observational studies or clinical trials cannot always be adjusted for. CONCLUSIONS: Event rates in EuroSIDA were similar in the first two years to those used in the design of ESPRIT, but did not increase over time, leading to an increase in the expected duration of ESPRIT. Clinical endpoint trials in HIV...

  11. The feasibility of using a parenting programme for the prevention of unintentional home injuries in the under-fives: a cluster randomised controlled trial.

    Science.gov (United States)

    Mytton, Julie; Ingram, Jenny; Manns, Sarah; Stevens, Tony; Mulvaney, Caroline; Blair, Peter; Powell, Jane; Potter, Barbara; Towner, Elizabeth; Emond, Alan; Deave, Toity; Thomas, James; Kendrick, Denise; Stewart-Brown, Sarah

    2014-01-01

    Unintentional injury is the leading cause of preventable death of children over the age of 1 year in the UK and a major cause of attendance at emergency departments. Children having one injury are at increased risk of further injuries. Parenting programmes can reduce injuries in preschool children if delivered in the home and on a one-to-one basis. It is not known if group-based programmes delivered outside the home are effective. To develop (1) a parenting programme to prevent recurrent unintentional home injuries in preschool children and (2) a tool for parents to report unintentional home injuries occurring to their preschool children. To assess the feasibility of delivering and evaluating the parenting programme through a cluster randomised controlled trial, specifically to (1) assess methods for the recruitment and retention of parents; (2) determine the training, equipment and facilities needed for the delivery of the programme; (3) establish appropriate primary and secondary outcome measures and methods for their collection; (4) determine how 'normal care' in a comparison arm should be defined; and (5) determine the resource utilisation and costing data that would need to be collected for the cost-effectiveness component of a future trial; and (6) produce estimates of effect sizes to inform sample size estimation for a main trial. Feasibility multicentre, cluster, randomised, unblinded trial. Eight children's centres in Bristol and Nottingham, UK. Ninety-six parents of preschool children who had sustained an unintentional injury requiring medical attention in the previous 12 months. The First-aid Advice and Safety Training (FAST) parent programme, comprising parenting support and skills combined with first aid and home safety advice. Parent-reported medically attended injuries in the index child and any preschool siblings sustained during a 6-month period of observation. An 8-week parenting programme was produced, designed with participant

  12. Examining self-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety and depression: Two feasibility open trials

    Directory of Open Access Journals (Sweden)

    Blake F. Dear

    2015-03-01

    Full Text Available Self-guided internet-delivered cognitive behavior therapy (iCBT has considerable public health potential for treating anxiety and depression. However, no research has examined the use of self-guided iCBT, that is, treatment without contact with a clinician, specifically for older adults. The aim of the present study was to undertake a preliminary examination of the acceptability, efficacy and health economic impact of two entirely self-guided iCBT programs for adults over 60 years of age with anxiety and depression. Two separate single-group feasibility open trials of self-guided iCBT were conducted, the Anxiety Trial (n = 27 and the Depression Trial (n = 20, using the control groups of two randomized controlled trials. The online treatment packages consisted of five online educational lessons, which were delivered over 8 weeks without clinical contact. Participants rated the interventions as acceptable with more than 90% reporting the course was worth their time and more than 70% of participants completing at least 3 of the 5 lessons within the eight weeks. Significant reductions on measures of anxiety (Generalized Anxiety Disorder 7-item; GAD-7 and depression (Patient Health Questionnaire 9-item; PHQ-9 were observed from pre-treatment to post-treatment in both the Anxiety Trial (GAD-7 Cohen's d = 1.17; 95% CI: 0.55 to 1.75 and the Depression Trial (PHQ-9 Cohen's d = 1.06; 95% CI: 0.33 to 1.73. The economic analyses indicated that there was statistically significant improvement in health-related quality of life compared to baseline and marginally higher costs associated with treatment for both the Anxiety Trial ($69.84; 95% CI: $4.24 to $135.45 and the Depression Trial ($54.98; 95% CI: $3.84 to $106.12. The results provide preliminary support for the potential of entirely self-guided iCBT for older adults with anxiety and depression and indicate larger scale and controlled research trials are warranted.

  13. Nurse-led immunotreatment DEcision Coaching In people with Multiple Sclerosis (DECIMS) - Feasibility testing, pilot randomised controlled trial and mixed methods process evaluation.

    Science.gov (United States)

    Rahn, A C; Köpke, S; Backhus, I; Kasper, J; Anger, K; Untiedt, B; Alegiani, A; Kleiter, I; Mühlhauser, I; Heesen, C

    2017-08-26

    Treatment decision-making is complex for people with multiple sclerosis. Profound information on available options is virtually not possible in regular neurologist encounters. The "nurse decision coach model" was developed to redistribute health professionals' tasks in supporting immunotreatment decision-making following the principles of informed shared decision-making. To test the feasibility of a decision coaching programme and recruitment strategies to inform the main trial. Feasibility testing and parallel pilot randomised controlled trial, accompanied by a mixed methods process evaluation. Two German multiple sclerosis university centres. People with suspected or relapsing-remitting multiple sclerosis facing immunotreatment decisions on first line drugs were recruited. Randomisation to the intervention (n = 38) or control group (n = 35) was performed on a daily basis. Quantitative and qualitative process data were collected from people with multiple sclerosis, nurses and physicians. We report on the development and piloting of the decision coaching programme. It comprises a training course for multiple sclerosis nurses and the coaching intervention. The intervention consists of up to three structured nurse-led decision coaching sessions, access to an evidence-based online information platform (DECIMS-Wiki) and a final physician consultation. After feasibility testing, a pilot randomised controlled trial was performed. People with multiple sclerosis were randomised to the intervention or control group. The latter had also access to the DECIMS-Wiki, but received otherwise care as usual. Nurses were not blinded to group assignment, while people with multiple sclerosis and physicians were. The primary outcome was 'informed choice' after six months including the sub-dimensions' risk knowledge (after 14 days), attitude concerning immunotreatment (after physician consultation), and treatment uptake (after six months). Quantitative process evaluation data

  14. [YANG's pricking-cupping therapy for knee osteoarthritis: a multi-center randomized controlled trial].

    Science.gov (United States)

    Wang, Bo; Liu, Xiru; Hu, Zhihai; Sun, Aijun; Ma, Yanwen; Chen Yingying; Zhang, Xuzhi; Liu, Meiling; Wang, Yi; Wang, Shuoshuo; Zhang, Yunjia; Li, Yijing; Shen, Weidong

    2016-02-01

    To evaluate the clinical efficacy of YANG's pricking-cupping therapy for knee osteoar thritis (KOA). Methods This was a multi-center randomized parallel controlled trial. One hundred and seventy one patients with KOA were randomly allocated to a pricking-cupping group (89 cases) and a conventional acu puncture group (82 cases). Neixiyan (EX-LE 4), Dubi (ST 35) and ashi points were selected in the two groups. Patients in the pricking-cupping group were treated with YANG's pricking-cupping therapy; the seven-star needles were used to perform pricking at acupoints, then cupping was used until slight bleeding was observed. Patients in the conventional acupuncture group were treated with semi-standardized filiform needle therapy. The treatment was given for 4 weeks (from a minimum of 5 times to a maximum of 10 times). The follow-up visit was 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analogue scale (VAS) were adopted for the efficacy assessments. The pain score, stiffness score, physical function score and total score of WOMAC were all reduced after 4-week treatment and during follow-up visit in the two groups (all P0. 05), each score and total score of WOMAC in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (Pcupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P cupping and conventional acupuncture therapy can both significantly improve knee joint pain and function in patients with KOA, which are relatively safe. The pricking cupping therapy is superior to conventional acupuncture with the identical selection of acupoints.

  15. Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans.

    Science.gov (United States)

    Skolarus, Lesli E; Cowdery, Joan; Dome, Mackenzie; Bailey, Sarah; Baek, Jonggyu; Byrd, James Brian; Hartley, Sarah E; Valley, Staci C; Saberi, Sima; Wheeler, Natalie C; McDermott, Mollie; Hughes, Rebecca; Shanmugasundaram, Krithika; Morgenstern, Lewis B; Brown, Devin L

    2017-06-01

    Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

  16. The first 100 patients in the SUN(^_^D trial (strategic use of new generation antidepressants for depression: examination of feasibility and adherence during the pilot phase

    Directory of Open Access Journals (Sweden)

    Shimodera Shinji

    2012-06-01

    Full Text Available Abstract Background Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial’s protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^D] and would like to herein report an examination of the trial’s feasibility and adherence among the first 100 participants. Methods We examined the participants’ characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^D trial. Results Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8% of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%. Of the 32 patients who had reached Week 25, 29 (90.5% were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary. Discussion Given the satisfactory

  17. Clinical feasibility of the Nintendo Wii™ for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting.

    Science.gov (United States)

    Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

    2014-09-01

    To investigate the feasibility and potential efficacy of the Nintendo Wii™ for balance rehabilitation after stroke. Phase II, single-blind, randomized controlled trial. Inpatient rehabilitation facility. Thirty adults (mean age 63.6 (14.7) years) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported. Participants were allocated to a Balance Group, using the 'Wii Fit Plus' in standing, or Upper Limb Group, using the 'Wii Sports/Sports Resort' in sitting. Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care. The primary focus was feasibility, addressed by recruitment, retention, adherence, acceptability and safety. Efficacy was evaluated by balance, mobility and upper limb outcomes. Twenty-one percent of individuals screened were recruited and 86% (n = 30) of eligible people agreed to participate. Study retention and session adherence was 90% and > 99%, respectively, at two weeks; dropping to 70% and 87% at four weeks due to early discharge. All participants reported enjoying the sessions and most felt they were beneficial. No major adverse events occurred. Wii use by the Balance Group was associated with trends for improved balance, with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores. The Upper Limb Group had larger, non-significant changes in arm function. A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation. A larger randomized controlled trial is recommended to further investigate efficacy. © The Author(s) 2014.

  18. Storytelling in the Early Bereavement Period to Reduce Emotional Distress Among Surrogates Involved in a Decision to Limit Life Support in the ICU: A Pilot Feasibility Trial.

    Science.gov (United States)

    Barnato, Amber E; Schenker, Yael; Tiver, Greer; Dew, Mary Amanda; Arnold, Robert M; Nunez, Eduardo R; Reynolds, Charles F

    2017-01-01

    Surrogate decision makers involved in decisions to limit life support for an incapacitated patient in the ICU have high rates of adverse emotional health outcomes distinct from normal processes of grief and bereavement. Narrative self-disclosure (storytelling) reduces emotional distress after other traumatic experiences. We sought to assess the feasibility, acceptability, and tolerability of storytelling among bereaved surrogates involved in a decision to limit life support in the ICU. Pilot single-blind trial. Five ICUs across three hospitals within a single health system between June 2013 and November 2014. Bereaved surrogates of ICU patients. Storytelling and control conditions involved printed bereavement materials and follow-up assessments. Storytelling involved a single 1- to 2-hour home or telephone visit by a trained interventionist who elicited the surrogate's story. The primary outcomes were feasibility (rates of enrollment, intervention receipt, 3- and 6-mo follow-up), acceptability (closed and open-ended end-of-study feedback at 6 mo), and tolerability (acute mental health services referral). Of 53 eligible surrogates, 32 (60%) consented to treatment allocation. Surrogates' mean age was 55.5 (SD, 11.8), and they were making decisions for their parent (47%), spouse (28%), sibling (13%), child (3%), or other relation (8%). We allocated 14 to control and 18 to storytelling, 17 of 18 (94%) received storytelling, 14 of 14 (100%) and 13 of 14 (94%) control subjects and 16 of 18 (89%) and 17 of 18 (94%) storytelling subjects completed their 3- and 6-month telephone assessments. At 6 months, nine of 13 control participants (69%) and 16 of 17 storytelling subjects (94%) reported feeling "better" or "much better," and none felt "much worse." One control subject (8%) and one storytelling subject (6%) said that the study was burdensome, and one control subject (8%) wished they had not participated. No subjects required acute mental health services referral. A

  19. Tailored nutritional guidance for home-dwelling AD families: the Feasibility of and Elements Promoting Positive Changes in Diet (NuAD-Trial).

    Science.gov (United States)

    Puranen, T M; Pitkala, K H; Suominen, M H

    2015-04-01

    To describe the process and feasibility of our randomised, controlled intervention study (NuAD trial) that positively affected the nutrition and quality of life, and prevented falls of home-dwelling persons with Alzheimer disease (AD). This qualitative study comprised 40 persons with AD and spousal caregivers of our trial. Our intervention during one year involved tailored nutritional guidance for these couples. The nutritionist's field notes (about 100 pages) and the participant feedback questionnaires (N = 28) served to analyse the feasibility of intervention, factors promoting the application of intervention and challenges hindering it. Thematic content analysis served to analyse our data with the grounded theory approach. We identified several positive elements promoting better nutrition: positive attitudes on nutrition to participants including a participant-centred approach, positive feedback, findings of food diaries and practical suggestions. Home visits by the nutritionist were convenient and participants felt that someone cares. Group meetings which included protein-rich snacks strengthened the nutritional message by enabling discussions and socialising. The oral nutritional supplements (ONS) helped participants to regain their energy and to motivate them to exercise and make changes in their diets. Obstacles to making changes in diets included participants' false ideas about nutrition, especially with regard to weight gain. Health problems and functional limitations hampered food management, and some families had inveterate eating habits. The positive feedback from participants indicated the feasibility of our tailored nutritional guidance. Assessment-based, tailored nutritional guidance implemented with a personal and positive approach may inspire and empower AD families to make positive changes in their diets, leading them to improved nutrition and quality of life.

  20. Care Management by Oncology Nurses To Address Palliative Care Needs: A Pilot Trial To Assess Feasibility, Acceptability, and Perceived Effectiveness of the CONNECT Intervention

    Science.gov (United States)

    White, Douglas; Rosenzweig, Margaret; Chu, Edward; Moore, Charity; Ellis, Peter; Nikolajski, Peggy; Ford, Colleen; Tiver, Greer; McCarthy, Lauren; Arnold, Robert

    2015-01-01

    Abstract Background: Specialty palliative care is not accessible for many patients with advanced cancer. There is a need to find alternative palliative care strategies in oncology clinics. Objective: The objective of the study was to assess the feasibility, acceptability, and perceived effectiveness of an oncology nurse-led care management approach to improve primary palliative care. Methods: The study design was a single-arm pilot trial of the Care Management by Oncology Nurses (CONNECT) intervention, in which registered oncology nurses receive specialized training and work closely with oncologists to (1) address symptom needs; (2) engage patients and caregivers in advance care planning; (3) provide emotional support; and (4) coordinate care. The subjects were 23 patients with advanced cancer, 19 caregivers, and 5 oncologists from a community oncology clinic in western Pennsylvania. Feasibility was assessed through enrollment rates, outcome assessment rates, and visit checklists. Patients, caregivers, and oncologists completed three-month assessments of acceptability and perceived effectiveness. Results: The consent-to-approach rate was 86% and enrolled-to-consent rate, 77%. CONNECT was implemented according to protocol for all participants. No participants withdrew after enrollment. Four patients died during the study; three-month outcome assessments were completed with all remaining participants (83%). Patients and caregivers reported high satisfaction with CONNECT and perceived the intervention as helpful in addressing symptoms (85%), coping (91%), and planning for the future (82%). Oncologists unanimously agreed that CONNECT improved the quality of care provided for patients with advanced cancer. Conclusion: An oncology nurse-led care management intervention is feasible, acceptable, and was perceived to be effective for improving provision of primary palliative care. A randomized trial of CONNECT is warranted. PMID:25517219

  1. Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Schneider, Kristin L; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M; Waring, Molly E; Appelhans, Bradley M; Whited, Matthew C; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L

    2016-03-01

    Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study. Copyright © 2015. Published by Elsevier Ltd.

  2. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial.

    Science.gov (United States)

    Reynolds, Rebecca M; Denison, Fiona C; Juszczak, Ed; Bell, Jennifer L; Penneycard, Jessica; Strachan, Mark W J; Lindsay, Robert S; Alexander, Claire I; Love, Corinne D B; Whyte, Sonia; Mackenzie, Fiona; Stenson, Ben; Norman, Jane E

    2017-09-22

    Metformin is widely used to treat gestational diabetes (GDM), but many women remain hyperglycaemic and require additional therapy. We aimed to determine recruitment rate and participant throughput in a randomised trial of glibenclamide compared with standard therapy insulin (added to maximum tolerated metformin) for treatment of GDM. We conducted an open label feasibility study in 5 UK antenatal clinics among pregnant women 16 to 36 weeks' gestation with metformin-treated GDM. Women failing to achieve adequate glycaemic control on metformin monotherapy were randomised to additional glibenclamide or insulin. The primary outcome was recruitment rate. We explored feasibility with uptake, retention, adherence, safety, glycaemic control, participant satisfaction and clinical outcomes. Records of 197 women were screened and 23 women randomised to metformin and glibenclamide (n = 13) or metformin and insulin (n = 10). Mean (SD) recruitment rate was 0.39 (0.62) women/centre/month. 9/13 (69.2%, 95%CI 38.6-90.9%) women adhered to glibenclamide and all provided outcome data (100% retention). There were no episodes of severe hypoglycaemia, but metformin and insulin gave superior glycaemic control to metformin and glibenclamide, with fewer blood glucose readings woman/week of treatment 0.58 [0.03-1.87]). A large randomised controlled trial comparing glibenclamide or insulin in combination with metformin for women with GDM would be feasible but is unlikely to be worthwhile, given the poorer glycaemic control with glibenclamide and metformin in this pilot study. The combination of metformin and glibenclamide should be reserved for women with GDM with true needle phobia or inability to use insulin therapy. www.clinicaltrials.gov registration number:NCT02080377 February 11th 2014.

  3. A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol.

    Science.gov (United States)

    O'Neil, Adrienne; Hawkes, Anna L; Chan, Bianca; Sanderson, Kristy; Forbes, Andrew; Hollingsworth, Bruce; Atherton, John; Hare, David L; Jelinek, Michael; Eadie, Kathy; Taylor, C Barr; Oldenburg, Brian

    2011-02-25

    Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare) for depression and CHD secondary prevention, with Usual Care (UC). Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group). The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake), medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1), 6 months (post-intervention) (Time 2), 12 months (Time 3) and 24 months follow-up for longer term effects (Time 4). We are comparing depression (Cardiac Depression Scale [CDS]) and HRQOL (Short Form-12 [SF-12]) scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of the costs and outcomes for

  4. A feasibility dosimetric study on prostate cancer. Are we ready for a multicenter clinical trial on SBRT?

    Energy Technology Data Exchange (ETDEWEB)

    Marino, Carmelo; Bonanno, Elisa [Humanitas C.C.O., Catania (Italy); Villaggi, Elena [AUSL, Piacenza (Italy); Maggi, Giulia; Mancosu, Pietro [IRCCS Humanitas Clinical Research Center, Milan (Italy); Esposito, Marco [Azienda Sanitaria Firenze (Italy); Strigari, Lidia [Regina Elena National Cancer Institute, Rome (Italy). Lab. of Medical Physics and Expert Systems; Borzi, Giusi R. [REM Radioterapia, Catania (Italy); Carbonini, Claudia [A.O. Ospedale Niguarda Ca' Granda, Milan (Italy); Consorti, Rita [ACO S. Filippo Neri, Rome (Italy); Fedele, David [Casa di Cura Privata San Rossore s.r.l., Pisa (Italy); Fiandra, Christian [Torino Univ. (Italy). Radiation Oncology Unit; Ielo, Isidora [A.O.U. Policlinico G. Martino, Messina (Italy); Malatesta, Tiziana [' ' S. Giovanni Calibita' ' Fatebenefratelli, Rome (Italy); Malisan, Maria Rosa [Azienda Ospedaliero-Universitaria di Udine (Italy); Martinotti, Anna [Centro Diagnostico Italiano, Milan (Italy); Moretti, Renzo [Az. Ospedaliera Spedali Civili di Brescia (Italy); Nardiello, Barbara [UPMC San Pietro FBF, Rome (Italy); Oliviero, Caterina; Clemente, Stefania [IRCCS CROB Rieonero in Vulture, Potenza (Italy)

    2015-07-15

    The Italian Association of Medical Physics (AIFM) started a working group dedicated to stereotactic body radiotherapy (SBRT) treatment. In this work, we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals. Fourteen centers were provided the contours of 5 patients. Plans were performed following the dose prescription and constraints for organs at risk (OARs) of a reference paper. The dose prescription was 35 Gy in five fractions for the planning target volume (PTV). Different techniques were used (3D-CRT, fixed-Field IMRT, VMAT, CyberKnife). Plans were compared in terms of dose-volume histogram (DVH) parameters. Furthermore, the median DVH was calculated and one patient was re-planned. A total of 70 plans were compared. The maximum dose to the body was 107.9 ± 4.5 % (range 101.5-116.3 %). Dose at 98 % (D{sub 98} {sub %}) and mean dose to the clinical target volume (CTV) were 102.0 ± 0.9 % (global range 101.1-102.9 %) and 105.1 ± 0.6 % (range 98.6-124.6 %). Similar trends were found for D{sub 95} {sub %} and mean dose to the PTV. Important differences were found in terms of the homogeneity index. Doses to OARs were heterogeneous. The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group. In the re-optimized plans, DVH differences among institutes were reduced and OAR sparing improved. Important dosimetric differences with possible clinical implications, in particular related to OARs, were found. Replanning allowed a reduction in the OAR dose and decreased standard deviations. Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure. (orig.) [German] Der italienische Verband der Medizinphysiker (AIFM) hat eine Arbeitsgruppe gegruendet, die sich mit der Koerperstammstereotaxie (SBRT) befasst. Im Rahmen

  5. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  6. Use of an interactive video gaming program compared with conventional physiotherapy for hospitalised older adults: a feasibility trial.

    Science.gov (United States)

    Laver, Kate; George, Stacey; Ratcliffe, Julie; Quinn, Steve; Whitehead, Craig; Davies, Owen; Crotty, Maria

    2012-01-01

    To assess the feasibility of a physiotherapy intervention using an interactive gaming program compared with conventional physiotherapy for hospitalised older people. Randomised controlled pilot study in a geriatric rehabilitation unit within an acute public hospital. Participants were randomly allocated to physiotherapy using an interactive gaming program (n = 22) or conventional physiotherapy in a ward-based gym (n = 22). Feasibility was assessed by comparing the effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by the Timed Up and Go test, secondary outcomes: safety, adherence levels, eligibility and consent rates). Participants (n = 44) had a mean age of 85 years (SD 4.5) and the majority (80%) were women. Univariable analyses showed no significant difference between groups following intervention. However, multivariable analyses suggested that participants using the interactive gaming program improved more on the Timed Up and Go test (p = 0.048) than participants receiving conventional physiotherapy. There were no serious adverse events and high levels of adherence to therapy were evident in both groups. Only a small proportion of patients screened were recruited to the study. In this feasibility study, the use of a commercially available interactive gaming program by physiotherapists with older people in a hospital setting was safe and adherence levels were comparable with conventional therapy. Preliminary results suggest that further exploration of approaches using games as therapy for older people could include commonly used measures of balance and function.

  7. The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

    Science.gov (United States)

    Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

    2015-01-01

    Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

  8. DOT-C: A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy.

    Science.gov (United States)

    Radley, Andrew; Tait, Jan; Dillon, John F

    2017-09-01

    Direct-acting antiviral therapy (DAAs) for hepatitis C infection (HCV) have a much smaller burden of treatment than interferon-based regimes, require less monitoring and are very effective. New pathways are required to increase access to treatment amongst people prescribed opioid substitution therapy (OST). An exploratory cluster randomised controlled trial with mixed methods evaluation was undertaken to compare the uptake of dried blood spot testing (DBST) and treatment of people with genotype 1 HCV infection in a conventional service pathway versus a pharmacist-led pathway in a population receiving OST. Pharmacies randomised to the conventional pathway obtained 58 DBST from 244 patients (24%):15 new reactive tests and 33 new negative tests were identified. Within the pharmacist-led pathway, 94 DBST were obtained from 262 patients (36%): 26 new reactive tests and 54 new negative tests were identified. Participants in the pharmacist-led pathway were more likely to take a DBST (ptreatment through the conventional pathway, 4 patients from 15 with new reactive tests (27%) attended clinic for assessment. In the pharmacist-led treatment pathway, 20 patients from 26 with new reactive tests (77%) attended for assessment blood tests. Participants in the pharmacist-led pathway were more likely to proceed through the assessment for treatment (ptreatment through the conventional pathway and three patients completed treatment through the pharmacist-led pathway. The process evaluation identified key themes important to service user completers and staff participants. The study provides evidence that testing and treatment for HCV in a pharmacist led-pathway is a feasible treatment pathway for people who receive supervised OST consumption through community pharmacies. This feasibility trial therefore provides sufficient confirmation to justify proceeding to a full trial. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Effects and feasibility of a standardised orientation and mobility training in using an identification cane for older adults with low vision: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van der Velde J

    2009-08-01

    Full Text Available Abstract Background Orientation and mobility training (O&M-training in using an identification cane, also called symbol cane, is provided to people with low vision to facilitate independent participation in the community. In The Netherlands this training is mainly practice-based because a standardised and validly evaluated O&M-training in using the identification cane is lacking. Recently a standardised O&M-training in using the identification cane was developed. This training consists of two face-to-face sessions and one telephone session during which, in addition to usual care, the client's needs regarding mobility are prioritised, and cognitive restructuring techniques, action planning and contracting are applied to facilitate the use of the cane. This paper presents the design of a randomised controlled trial aimed to evaluate this standardised O&M-training in using the identification cane in older adults with low vision. Methods/design A parallel group randomised controlled trial was designed to compare the standardised O&M-training with usual care, i.e. the O&M-training commonly provided by the mobility trainer. Community-dwelling older people who ask for support at a rehabilitation centre for people with visual impairment and who are likely to receive an O&M-training in using the identification cane are included in the trial (N = 190. The primary outcomes of the effect evaluation are ADL self care and visual functioning with respect to distance activities and mobility. Secondary outcomes include quality of life, feelings of anxiety, symptoms of depression, fear of falling, and falls history. Data for the effect evaluation are collected by means of telephone interviews at baseline, and at 5 and 17 weeks after the start of the O&M-training. In addition to an effect evaluation, a process evaluation to study the feasibility of the O&M-training is carried out. Discussion The screening procedure for eligible participants started in November

  10. Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis: The First Results From the Randomized Controlled Trial DILALA.

    Science.gov (United States)

    Angenete, Eva; Thornell, Anders; Burcharth, Jakob; Pommergaard, Hans-Christian; Skullman, Stefan; Bisgaard, Thue; Jess, Per; Läckberg, Zoltan; Matthiessen, Peter; Heath, Jane; Rosenberg, Jacob; Haglind, Eva

    2016-01-01

    To evaluate short-term outcomes of a new treatment for perforated diverticulitis with purulent peritonitis in a randomized controlled trial. Perforated diverticulitis with purulent peritonitis (Hinchey III) has traditionally been treated with surgery including colon resection and stoma (Hartmann procedure) with considerable postoperative morbidity and mortality. Laparoscopic lavage has been suggested as a less invasive surgical treatment. Laparoscopic lavage was compared with colon resection and stoma in a randomized controlled multicenter trial, DILALA (ISRCTN82208287). Initial diagnostic laparoscopy showing Hinchey III was followed by randomization. Clinical data was collected up to 12 weeks postoperatively. Eighty-three patients were randomized, out of whom 39 patients in laparoscopic lavage and 36 patients in the Hartmann procedure groups were available for analysis. Morbidity and mortality after laparoscopic lavage did not differ when compared with the Hartmann procedure. Laparoscopic lavage resulted in shorter operating time, shorter time in the recovery unit, and shorter hospital stay. In this trial, laparoscopic lavage as treatment for patients with perforated diverticulitis Hinchey III was feasible and safe in the short-term.

  11. Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.

    Science.gov (United States)

    Steers, William; Richter, Holly; Nyberg, Leroy; Kusek, John; Kraus, Stephen; Dandreo, Kimberly; Chai, Toby; Brubaker, Linda

    2009-01-01

    The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence.

  12. Person-Centered Integrated Care for Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Valentijn, Pim P; Pereira, Fernando Abdalla; Ruospo, Marinella; Palmer, Suetonia C; Hegbrant, Jörgen; Sterner, Christina W; Vrijhoef, Hubertus J M; Ruwaard, Dirk; Strippoli, Giovanni F M

    2018-02-09

    The effectiveness of person-centered integrated care strategies for CKD is uncertain. We conducted a systematic review and meta-analysis of randomized, controlled trials to assess the effect of person-centered integrated care for CKD. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to April of 2016), and selected randomized, controlled trials of person-centered integrated care interventions with a minimum follow-up of 3 months. Random-effects meta-analysis was used to assess the effect of person-centered integrated care. We included 14 eligible studies covering 4693 participants with a mean follow-up of 12 months. In moderate quality evidence, person-centered integrated care probably had no effect on all-cause mortality (relative risk [RR], 0.86; 95% confidence interval [95% CI], 0.68 to 1.08) or health-related quality of life (standardized mean difference, 0.02; 95% CI, -0.05 to 0.10). The effects on renal replacement therapy (RRT) (RR, 1.00; 95% CI, 0.65 to 1.55), serum creatinine levels (mean difference, 0.59 mg/dl; 95% CI, -0.38 to 0.36), and eGFR (mean difference, 1.51 ml/min per 1.73 m 2 ; 95% CI, -3.25 to 6.27) were very uncertain. Quantitative analysis suggested that person-centered integrated care interventions may reduce all-cause hospitalization (RR, 0.38; 95% CI, 0.15 to 0.95) and improve BP control (RR, 1.20; 95% CI, 1.00 to 1.44), although the certainty of the evidence was very low. Person-centered integrated care may have little effect on mortality or quality of life. The effects on serum creatinine, eGFR, and RRT are uncertain, although person-centered integrated care may lead to fewer hospitalizations and improved BP control. Copyright © 2018 by the American Society of Nephrology.

  13. A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial.

    Science.gov (United States)

    Skafjeld, Anita; Iversen, Marjolein M; Holme, Ingar; Ribu, Lis; Hvaal, Kjetil; Kilhovd, Bente K

    2015-10-09

    Although monitoring foot skin temperatures has been associated with diabetic foot ulcer recurrence, no studies have been carried out to test the feasibility among European Caucasians. Moreover, the educational and/or motivational models that promote cognitive or psychosocial processes in these studies are lacking. Thus, we conducted a pilot randomized controlled trial to test the feasibility of monitoring foot skin temperatures in combination with theory-based counselling to standard foot care to reduce diabetic foot ulcer recurrence. In a single-blinded nurse-led 1-year controlled trial, conducted at a hospital setting in Norway, 41 patients with diabetic neuropathy and previous foot ulcer were randomized to the intervention (n = 21) or control groups (n = 20). All participants were instructed in foot care and recording observations daily. Additionally, the intervention group was taught how to monitor and record skin temperature at baseline, and received counselling every third month supporting them to use the new treatment. Subjects observing temperature differences > 2.0 °C between corresponding sites on the left and right foot on two consecutive days were asked to contact the study nurse and reduce physical activity. Fisher exact test was used to evaluate the effect of the intervention on the proportion of subjects with a foot ulcer. Kaplan-Meier survival analysis was performed to compare the two groups in regard to the time to development of a foot ulcer. In the intervention group, 67 % (n = 14/21) monitored and recorded skin temperatures ≥ 80 % of the time while 70 % (n = 14/20) of the controls recorded foot inspections. Foot ulcer incidence was 39 % (7/21) vs. 50 % (10/20) in the intervention and control groups, respectively (ns). This feasibility study showed that the addition of counselling to promote self-monitoring of skin temperature to standard care to prevent recurrence of foot ulcer is feasible in patients with diabetes in Norway. Home skin

  14. Center-size as a predictor of weight-loss outcome in multicenter trials including a low-calorie diet

    DEFF Research Database (Denmark)

    Gasteyger, Christoph Rolf; Christensen, Robin; Larsen, Thomas Meinert

    2010-01-01

    It has not been studied yet whether factors such as the number of subjects recruited by specialized centers for multicenter trials may influence weight loss during a low-calorie diet (LCD). This study aimed at determining whether the number of recruited subjects per center might predict relative...... weight loss. This is a post hoc analysis of an existing database: 701 obese subjects (77% women, 23% men, mean BMI: 38.9 kg/m(2)) were enrolled at 22 sites (4-85 subjects/site) in five countries to follow a LCD providing 800-1,000 kcal/day during 8 weeks. The main outcome measure was the percentage...... weight loss after the 8-week LCD. Mean weight loss differed significantly between participating centers (5.8-11.8% of the initial weight; P

  15. Computer modeling with randomized-controlled trial data informs the development of person-centered aged care homes.

    Science.gov (United States)

    Chenoweth, Lynn; Vickland, Victor; Stein-Parbury, Jane; Jeon, Yun-Hee; Kenny, Patricia; Brodaty, Henry

    2015-10-01

    To answer questions on the essential components (services, operations and resources) of a person-centered aged care home (iHome) using computer simulation. iHome was developed with AnyLogic software using extant study data obtained from 60 Australian aged care homes, 900+ clients and 700+ aged care staff. Bayesian analysis of simulated trial data will determine the influence of different iHome characteristics on care service quality and client outcomes. Interim results: A person-centered aged care home (socio-cultural context) and care/lifestyle services (interactional environment) can produce positive outcomes for aged care clients (subjective experiences) in the simulated environment. Further testing will define essential characteristics of a person-centered care home.

  16. A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

    Science.gov (United States)

    Huberty, Jennifer; Matthews, Jeni; Leiferman, Jenn; Cacciatore, Joanne; Gold, Katherine J

    2018-01-01

    In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted within this population, novel approaches targeting physical and mental health, specific to the needs of this population, are critical. Evidence suggests that yoga is efficacious, safe, acceptable, and cost-effective for improving mental health in a variety of populations, including pregnant and postpartum women. To date, there are no known studies examining online-streaming yoga as a strategy to help mothers cope with PTSD symptoms after stillbirth. The present study is a two-phase randomized controlled trial. Phase 1 will involve (1) an iterative design process to develop the online yoga prescription for phase 2 and (2) qualitative interviews to identify cultural barriers to recruitment in non-Caucasian women (i.e., predominately Hispanic and/or African American) who have experienced stillbirth (N = 5). Phase 2 is a three-group randomized feasibility trial with assessments at baseline, and at 12 and 20 weeks post-intervention. Ninety women who have experienced a stillbirth within 6 weeks to 24 months will be randomized into one of the following three arms for 12 weeks: (1) intervention low dose (LD) = 60 min/week online-streaming yoga (n = 30), (2) intervention moderate dose (MD) = 150 min/week online-streaming yoga (n = 30), or (3) stretch and tone control (STC) group = 60 min/week of stretching/toning exercises (n = 30). This study will explore the feasibility and acceptability of a 12-week, home-based, online-streamed yoga intervention, with varying doses among

  17. Counselling versus low-intensity cognitive behavioural therapy for persistent sub-threshold and mild depression (CLICD): a pilot/feasibility randomised controlled trial.

    Science.gov (United States)

    Freire, Elizabeth; Williams, Christopher; Messow, Claudia-Martina; Cooper, Mick; Elliott, Robert; McConnachie, Alex; Walker, Andrew; Heard, Deborah; Morrison, Jill

    2015-08-15

    Persistent depressive symptoms below the threshold criteria for major depression represent a chronic condition with high risk of progression to a diagnosis of major depression. The evidence base for psychological treatments such as Person-Centred Counselling and Low-Intensity Cognitive Behavioural Therapy for sub-threshold depressive symptoms and mild depression is limited, particularly for longer-term outcomes. This study aimed to test the feasibility of delivering a randomised controlled trial into the clinical and cost effectiveness of Low-Intensity Cognitive Behavioural Therapy versus Person-Centred Counselling for patients with persistent sub-threshold depressive symptoms and mild depression. The primary outcome measures for this pilot/feasibility trial were recruitment, adherence and retention rates at six months from baseline. An important secondary outcome measure was recovery from, or prevention of, depression at six months assessed via a structured clinical interview by an independent assessor blind to the participant's treatment condition. Thirty-six patients were recruited in five general practices and were randomised to either eight weekly sessions of person-centred counselling each lasting up to an hour, or up to eight weeks of cognitive-behavioural self-help resources with guided telephone support sessions lasting 20-30 minutes each. Recruitment rate in relation to the number of patients approached at the general practices was 1.8 %. Patients attended an average of 5.5 sessions in both interventions. Retention rate for the 6-month follow-up assessments was 72.2 %. Of participants assessed at six months, 71.4 % of participants with a diagnosis of mild depression at baseline had recovered, while 66.7 % with a diagnosis of persistent subthreshold depression at baseline had not developed major depression. There were no significant differences between treatment groups for both recovery and prevention of depression at six months or on any of the outcome

  18. A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design

    Directory of Open Access Journals (Sweden)

    Lambert Sylvie D

    2012-09-01

    Full Text Available Abstract Background Although it is known both patients’ and partners’ reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients’ partners’ reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples’ illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD. Methods/design In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1 Coping-Together or 2 a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping will be assessed at baseline (before receiving study material and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted. Discussion As partners’ distress rates exceed not only population

  19. The acceptability and feasibility of a brief psychosocial intervention to reduce blood-borne virus risk behaviours among people who inject drugs: a randomised control feasibility trial of a psychosocial intervention (the PROTECT study) versus treatment as usual.

    Science.gov (United States)

    Gilchrist, Gail; Swan, Davina; Shaw, April; Keding, Ada; Towers, Sarah; Craine, Noel; Munro, Alison; Hughes, Elizabeth; Parrott, Steve; Strang, John; Taylor, Avril; Watson, Judith

    2017-03-21

    questionnaire categories that could be excluded from the assessment battery in a full-randomised controlled trial. Findings should be interpreted with caution due to small sample sizes. A future definitive RCT of the psychosocial intervention is not feasible. The complex needs of some PWID may have limited their engagement in the intervention. More flexible delivery methods may have greater reach. ISRCTN66453696.

  20. How legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementia.

    Science.gov (United States)

    Galeotti, Francesca; Vanacore, Nicola; Gainotti, Sabina; Izzicupo, Fabio; Menniti-Ippolito, Francesca; Petrini, Carlo; Chiarotti, Flavia; Chattat, Rabih; Raschetti, Roberto

    2012-08-01

    Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the trial. Fifty-six patients (68%) were included with consent given by a legal representative, while 27 patients (32%) were considered to provide personal informed consent on the basis of the results from a specifically built procedure. Patients and caregivers were offered the opportunity to participate in the trial before the occurrence of behavioural disturbances, in order to provide them with enough time to consider their participation in the study. Twenty-three patients experienced behavioural, clinically relevant symptoms and were randomized to the study drug; all randomized patients except one had consent for inclusion in the study given by legal representatives. After trial interruption, all patients taking an active drug continued

  1. Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

    Directory of Open Access Journals (Sweden)

    Julia V Bailey

    2015-10-01

    The best way to assess the impact of the MenSS website was by recording STI diagnoses from clinical records. Response rates for the online questionnaire were poor despite offers of incentives. There were many challenges to conducting an online trial of a sexual health website including ethical committee concerns about email content, poor reliability of trial-related software, balancing data protection and security protocols against ease of access for participants, barriers to patient access to IT in NHS clinics, and trying to ensure that participants engage with a digital intervention for long enough. Whilst digital interventions have great potential for health promotion, we encountered significant obstacles to online research, and to implementation of an IDI in an NHS clinical setting.

  2. Do soft skills predict surgical performance?: a single-center randomized controlled trial evaluating predictors of skill acquisition in virtual reality laparoscopy.

    Science.gov (United States)

    Maschuw, K; Schlosser, K; Kupietz, E; Slater, E P; Weyers, P; Hassan, I

    2011-03-01

    Virtual reality (VR) training in minimal invasive surgery (MIS) is feasible in surgical residency and beneficial for the performance of MIS by surgical trainees. Research on stress-coping of surgical trainees indicates the additional impact of soft skills on VR performance in the surgical curriculum. The aim of this study was to evaluate the impact of structured VR training and soft skills on VR performance of trainees. The study was designed as a single-center randomized controlled trial. Fifty first-year surgical residents with limited experience in MIS ("camera navigation" in laparoscopic cholecystectomy only) were randomized for either 3 months of VR training or no training. Basic VR performance and defined soft skills (self-efficacy, stress-coping, and motivation) were assessed prior to randomization using basic modules of the VR simulator LapSim(®) and standardized psychological questionnaires. Three months after randomization VR performance was reassessed. Outcome measurement was based on the results derived from the most complex of the basic VR modules ("diathermy cutting") as the primary end point. A correlation analysis of the VR end-point performance and the psychological scores was done in both groups. Structured VR training enhanced VR performance of surgical trainees. An additional correlation to high motivational states (P 0.05). Low self-efficacy and negative stress-coping strategies seem to predict poor VR performance. However, structured training along with high motivational states is likely to balance out this impairment.

  3. Effects and feasibility of a standardised orientation and mobility training in using an identification cane for older adults with low vision: design of a randomised controlled trial.

    Science.gov (United States)

    Zijlstra, G A R; van Rens, G H M B; Scherder, E J A; Brouwer, D M; van der Velde, J; Verstraten, P F J; Kempen, G I J M

    2009-08-27

    Orientation and mobility training (O&M-training) in using an identification cane, also called symbol cane, is provided to people with low vision to facilitate independent participation in the community. In The Netherlands this training is mainly practice-based because a standardised and validly evaluated O&M-training in using the identification cane is lacking. Recently a standardised O&M-training in using the identification cane was developed. This training consists of two face-to-face sessions and one telephone session during which, in addition to usual care, the client's needs regarding mobility are prioritised, and cognitive restructuring techniques, action planning and contracting are applied to facilitate the use of the cane. This paper presents the design of a randomised controlled trial aimed to evaluate this standardised O&M-training in using the identification cane in older adults with low vision. A parallel group randomised controlled trial was designed to compare the standardised O&M-training with usual care, i.e. the O&M-training commonly provided by the mobility trainer. Community-dwelling older people who ask for support at a rehabilitation centre for people with visual impairment and who are likely to receive an O&M-training in using the identification cane are included in the trial (N = 190). The primary outcomes of the effect evaluation are ADL self care and visual functioning with respect to distance activities and mobility. Secondary outcomes include quality of life, feelings of anxiety, symptoms of depression, fear of falling, and falls history. Data for the effect evaluation are collected by means of telephone interviews at baseline, and at 5 and 17 weeks after the start of the O&M-training. In addition to an effect evaluation, a process evaluation to study the feasibility of the O&M-training is carried out. The screening procedure for eligible participants started in November 2007 and will continue until October 2009. Preliminary findings

  4. Cancer Clinical Trials at the National Institutes of Health Clinical Center

    Science.gov (United States)

    ... doctors, nurses and care specialists who specialize in carrying out clinical trials that are testing new treatments. ... as an outpatient . However, you are responsible for costs related to your initial screening. Even though most ...

  5. Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Ledderer, Loni; la Cour, Karen; Mogensen, Ole

    2013-01-01

    Background Cancer often affects the quality of life and well-being of patients as well as their relatives. Previous studies have suggested that relatives should be involved in psychosocial rehabilitation to address the needs for an interpersonal relationship with others in the disease trajectory....... We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair. Objective The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life. Methods...... The study was designed as an RCT comparing the new multimodal psychosocial rehabilitation with the usual services. The intervention comprised three ‘supportive talks’ and a residential rehabilitation course. From March 2010 to March 2011, participation was offered at the time of diagnosis to patients...

  6. Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730.

    Directory of Open Access Journals (Sweden)

    Nikola Sprigg

    Full Text Available Granulocyte-colony stimulating factor (G-CSF mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke.A pilot 2 x 2 factorial randomised (1:1 placebo-controlled trial of G-CSF (double-blind, and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1, at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment.Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12 and serious adverse events (SAE (9 vs 3, p = 0.10. On average, patients received 14 (out of 18 planned therapy sessions, interquartile range [12, 17]. Only a minority (23% of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21% were cancelled due to patient (94, 17% and therapist factors (20, 4%. No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365.Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design is not supported. Future work

  7. Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730).

    Science.gov (United States)

    Sprigg, Nikola; O'Connor, Rebecca; Woodhouse, Lisa; Krishnan, Kailash; England, Timothy J; Connell, Louise A; Walker, Marion F; Bath, Philip M

    2016-01-01

    Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke. A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment. Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12) and serious adverse events (SAE) (9 vs 3, p = 0.10). On average, patients received 14 (out of 18 planned) therapy sessions, interquartile range [12, 17]. Only a minority (23%) of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21%) were cancelled due to patient (94, 17%) and therapist factors (20, 4%). No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365. Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design is not supported. Future work should

  8. Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)

    OpenAIRE

    Russell, Ailsa; Cooper, Kate; Barton, Stephen; Ensum, Ian; Gaunt, Daisy; Horwood, Jeremy; Ingham, Barry; Kessler, David; Metcalfe, Chris; Parr, Jeremy; Rai, Dheeraj; Wiles, Nicola

    2017-01-01

    IntroductionHigh rates of co-occurring depression are reported in Autism Spectrum Disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group CBT for co-occurring depression, but no randomised trials investigating low intensity psychological interventions as recommended in clinical guidelines f...

  9. Screening for type 2 diabetes is feasible, acceptable, but associated with increased short-term anxiety: A randomised controlled trial in British general practice

    Directory of Open Access Journals (Sweden)

    Prevost A Toby

    2008-10-01

    Full Text Available Abstract Background To assess the feasibility and uptake of a diabetes screening programme; to examine the effects of invitation to diabetes screening on anxiety, self-rated health and illness perceptions. Methods Randomised controlled trial in two general practices in Cambridgeshire. Individuals aged 40–69 without known diabetes were identified as being at high risk of having undiagnosed type 2 diabetes using patient records and a validated risk score (n = 1,280. 355 individuals were randomised in a 2 to 1 ratio into non-invited (n = 238 and invited (n = 116 groups. A stepwise screening programme confirmed the presence or absence of diabetes. Six weeks after the last contact (either test or invitation, a questionnaire was sent to all participants, including non-attenders and those who were not originally invited. Outcome measures included attendance, anxiety (short-form Spielberger State Anxiety Inventory-STAI, self-rated health and diabetes illness perceptions. Results 95 people (82% of those invited attended for the initial capillary blood test. Six individuals were diagnosed with diabetes. Invited participants were more anxious than those not invited (37.6 vs. 34.1 STAI, p-value = 0.015, and those diagnosed with diabetes were considerably more anxious than those classified free of diabetes (46.7 vs. 37.0 STAI, p-value = 0.031. Non-attenders had a higher mean treatment control sub-scale (3.87 vs. 3.56, p-value = 0.016 and a lower mean emotional representation sub-scale (1.81 vs. 2.68, p-value = 0.001 than attenders. No differences in the other five illness perception sub-scales or self-rated health were found. Conclusion Screening for type 2 diabetes in primary care is feasible but may be associated with higher levels of short-term anxiety among invited compared with non-invited participants. Trial registration ISRCTN99175498

  10. Adapting the Trials of Improved Practices (TIPs) approach to explore the acceptability and feasibility of nutrition and parenting recommendations: what works for low-income families?

    Science.gov (United States)

    Dickin, Katherine L; Seim, Gretchen

    2015-10-01

    Interventions to prevent childhood obesity must consider not only how child feeding behaviours are related to child weight status but also which behaviours parents are willing and able to change. This study adapted Trials of Improved Practices (TIPs) to assess acceptability and feasibility of nutrition and parenting recommendations, using in-depth interviews and household trials to explore families' experiences over time. A diverse sample of 23 low-income parents of 3-11-year-olds was recruited following participation in nutrition and parenting education. Parents chose nutrition and parenting practices to try at home and were interviewed 2 weeks and 4-6 months later about behaviour change efforts. Qualitative analysis identified emergent themes, and acceptability and feasibility were rated based on parents' willingness and ability to try new practices. The nutrition goal parents chose most frequently was increasing children's vegetable intake, followed by replacing sweetened beverages with water or milk, and limiting energy-dense foods. Parents were less inclined to reduce serving sizes. The parenting practices most often selected as applicable to nutrition goals were role-modelling; shaping home environments, often with other adults; involving children in decisions; and providing positive feedback. Most recommendations were viewed as acceptable by meaningful numbers of parents, many of whom tried and sustained new behaviours. Food preferences, habits and time were common barriers; family resistance or food costs also constrained some parents. Despite challenges, TIPs was successfully adapted to evaluate complex nutrition and parenting practices. Information on parents' willingness and ability to try practices provides valuable guidance for childhood obesity prevention programmes. © 2013 John Wiley & Sons Ltd.

  11. Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial.

    Science.gov (United States)

    Willcox, Jane Catherine; Campbell, Karen Jane; McCarthy, Elizabeth Anne; Wilkinson, Shelley Ann; Lappas, Martha; Ball, Kylie; Fjeldsoe, Brianna; Griffiths, Anne; Whittaker, Robyn; Maddison, Ralph; Shub, Alexis; Pidd, Deborah; Fraser, Elise; Moshonas, Nelly; Crawford, David Andrew

    2015-05-07

    Overweight, obesity and excess gestational weight gain (GWG) are associated with negative health outcomes for mother and child in pregnancy and across the life course. Interventions promoting GWG within guidelines report mixed results. Most are time and cost intensive, which limits scalability. Mobile technologies (mHealth) offer low cost, ready access and individually-tailored support. We aim to test the feasibility of an mHealth intervention promoting healthy nutrition, physical activity and GWG in women who begin pregnancy overweight or obese. txt4two is a parallel randomised control trial pilot recruiting women with a singleton, live gestation between 10(+0) and 17(+6) weeks at the first hospital antenatal clinic visit. Inclusion criteria are pre-pregnancy BMI > 25 kg/m(2) and mobile phone ownership. One hundred consenting women will be randomised to intervention or control groups at a 1:1 ratio. All participants will receive standard antenatal care. In addition, the txt4two intervention will be delivered from baseline to 36 weeks gestation and consists of a tailored suite of theoretically-grounded, evidence-based intervention strategies focusing on healthy nutrition, physical activity and GWG. This includes: mobile phone interactive text messages promoting positive health behaviours, goal setting and self-monitoring; video messages; an information website; and a private moderated Facebook® chat forum. The primary outcome is the feasibility of the intervention. Secondary outcomes include GWG and participants' knowledge and behaviour regarding diet and physical activity during pregnancy. Findings will inform the development of larger-scale mHealth programmes to improve the delivery of healthy pregnancy nutrition, physical activity and GWG, that could be widely translated and disseminated. Australian New Zealand Clinical Trials Registry: ACTRNU111111544397 . Date of registration: 19 March 2014.

  12. Effects of two physical therapy interventions in patients with chronic non-specific low back pain: feasibility of a randomized controlled trial.

    Science.gov (United States)

    Garcia, Alessandra N; Gondo, Francine L B; Costa, Renata A; Cyrillo, Fábio N; Costa, Leonardo O P

    2011-01-01

    Chronic non-specific low back pain is both a health and a socio-economic problem which is associated with disability as well as with emotional distress. The Mckenzie and Back School's techniques have been shown to be effective in the treatment of this condition. to perform a preliminary analysis of the effects of these treatments in patients with chronic non specific low back pain for the following outcomes: pain, disability and trunk flexion range of motion and to test the feasibility of randomized controlled trial testing these interventions on this population. the participants were assessed by a blinded assessor and randomly assigned into one of the treatment groups. The data analysis was performed in only 18 patients and the study is still ongoing, so the results are restricted to these patients, as a single group. the patients improved for the outcomes pain intensity (mean difference of 2.4 points and 95% CI 0.84 to 3.93) and disability (5.2 points and 95% CI 2.55 to 7.78), but no improvement in range of motion in flexion was observed (7.2 degrees 95% CI -1.82 to 16.29). the Mckenzie and Back School's approaches may be beneficial for the treatment of patients with chronic non specific low back pain for the outcomes pain intensity and disability. We also concluded that the study is feasible and we will continue performing the current study without any adjustments of the original research protocol. This study was prospectively registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12610000435088.

  13. Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial.

    Science.gov (United States)

    Givon, Noa; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

    2016-04-01

    To investigate the feasibility of using video-games in a group setting and to compare the effectiveness of video-games as a group intervention to a traditional group intervention for improving physical activity in individuals with chronic stroke. A single-blind randomized controlled trial with evaluations pre and post a 3-month intervention, and at 3-month follow-up. Compliance (session attendance), satisfaction and adverse effects were feasibility measures. Grip strength and gait speed were measures of physical activity. Hip accelerometers quantified steps/day and the Action Research Arm Test assessed the functional ability of the upper extremity. Forty-seven community-dwelling individuals with chronic stroke (29-78 years) were randomly allocated to receive video-game (N=24) or traditional therapy (N=23) in a group setting. There was high treatment compliance for both interventions (video-games-78%, traditional therapy-66%), but satisfaction was rated higher for the video-game (93%) than the traditional therapy (71%) (χ(2)=4.98, P=0.026). Adverse effects were not reported in either group. Significant improvements were demonstrated in both groups for gait speed (F=3.9, P=0.02), grip strength of the weaker (F=6.67, P=0.002) and stronger hands (F=7.5, P=0.001). Daily steps and functional ability of the weaker hand did not increase in either group. Using video-games in a small group setting is feasible, safe and satisfying. Video-games improve indicators of physical activity of individuals with chronic stroke. © The Author(s) 2015.

  14. A randomized controlled trial of two simple mind-body programs, Kirtan Kriya meditation and music listening, for adults with subjective cognitive decline: Feasibility and acceptability.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2016-06-01

    In this randomized controlled trial (RCT), we assessed the feasibility and acceptability of two simple home-based relaxation programs in adults experiencing subjective cognitive decline, a strong predictor of Alzheimer's disease. Sixty participants were randomized to a beginner Kirtan Kriya meditation (KK) program or a music listening (ML) program. Participants were asked to practice 12min daily for the first 12 weeks, then as often as they liked for the following 3 months. Participants underwent assessments at baseline, 12 weeks, and 6 months to evaluate changes in key outcomes. Feasibility and acceptability were evaluated by measuring recruitment and retention rates, assessment visit attendance, practice adherence, and treatment expectancy; exit questionnaires completed at 12 weeks and 6 months provided additional data regarding participant experience with the study, perceived barriers to and facilitators of practice, reasons for drop-out, and views regarding the assigned intervention. Fifty-three participants (88%) completed the 6 month study. Adherence in both groups was excellent, with participants completing 93% (91% KK, 94% ML) of sessions on average in the first 12 weeks, and 71% (68% KK, 74% ML) during the 3 month, practice-optional, follow-up period. At week 12, over 80% of participants indicated they were likely to continue practicing following study completion. Responses to both structured and open-ended exit questionnaire items also suggested high satisfaction with both programs. Findings of this RCT of a beginner meditation practice and a simple ML program suggest that both programs were well accepted and the practices are feasible in adults with early memory loss. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. The feasibility of whole body vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013

    Directory of Open Access Journals (Sweden)

    Van Hees Ellen

    2005-12-01

    Full Text Available Abstract Background Fatigue or lack of interest can reduce the feasibility of intensive physical exercise in nursing home residents. Low-volume exercise interventions with similar training effects might be an alternative. The aim of this randomised controlled trial was to investigate the feasibility of Whole Body Vibration (WBV in institutionalised elderly, and its impact on functional capacity and muscle performance. Methods Twenty-four nursing home residents (15 female, 9 male; mean age 77.5 ± 11.0 years were randomised (stratification for age, gender and ADL-category to 6 weeks static WBV exercise (WBV+, N = 13 or control (only static exercise; N = 11. Outcome measures were exercise compliance, timed up-and-go, Tinetti-test, back scratch, chair sit-and-reach, handgrip strength and linear isokinetic leg extension. Results At baseline, WBV+ and control groups were similar for all outcome variables. Twenty-one participants completed the program and attended respectively 96% and 86% of the exercise sessions for the WBV+ and control groups. Training-induced changes in timed up-and-go and Tinetti-test were better for WBV+ compared to control (p = 0.029 for timed up-and-go, p = 0.001 and p = 0.002 for Tinetti body balance and total score respectively. In an alternative analysis (Worst Rank Score & Last Observation Carried Forward the differences in change remained significant on the Tinetti body balance and total score. No other significant differences in change between both groups were observed. Conclusion In nursing home residents with limited functional dependency, six weeks static WBV exercise is feasible, and is beneficial for balance and mobility. The supplementary benefit of WBV on muscle performance compared to classic exercise remains to be explored further.

  16. Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial.

    Science.gov (United States)

    Jensen, Bente Thoft; Laustsen, Sussie; Jensen, Jørgen Bjerggaard; Borre, Michael; Petersen, Annemette Krintel

    2016-08-01

    Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC). A parent prospective randomized controlled clinical trial investigated efficacy of a multidisciplinary rehabilitation program on length of stay following RC. A total of 107 patients were included in the intension-to-treat population revealing 50 patients in the intervention group and 57 patients in the standard group. Pre-operatively, the intervention group was instructed to a standardized exercise program consisting of both muscle strength exercises and endurance training. The number of training sessions and exercise repetitions was patient-reported. Feasibility was expressed as adherence to the program and efficacy as the differences in muscle power within and between treatment groups at time for surgery. A total of 66 % (95 % confidence interval (CI) 51; 78) adhered more than 75 % of the recommended progressive standardized exercise program. In the intervention group, a significant improvement in muscle power of 18 % (p group with 0.3 W/kg (95 % CI 0.08; 0.5 %) (p age. In patients awaiting RC, a short-term exercise-based pre-habilitation intervention is feasible and effective and should be considered in future survivorship strategies.

  17. Feasibility of Conducting a Palliative Care Randomized Controlled Trial in Children With Advanced Cancer: Assessment of the PediQUEST Study.

    Science.gov (United States)

    Dussel, Veronica; Orellana, Liliana; Soto, Natalie; Chen, Kun; Ullrich, Christina; Kang, Tammy I; Geyer, Jeffrey R; Feudtner, Chris; Wolfe, Joanne

    2015-06-01

    Pediatric palliative care randomized controlled trials (PPC-RCTs) are uncommon. To evaluate the feasibility of conducting a PPC-RCT in pediatric cancer patients. This was a cohort study embedded in the Pediatric Quality of Life and Evaluation of Symptoms Technology Study (NCT01838564). This multicenter PPC-RCT evaluated an electronic patient-reported outcomes system. Children aged two years and older, with advanced cancer, and potentially eligible for the study were included. Outcomes included: pre-inclusion attrition (patients not approached, refusals); post-inclusion attrition (drop-out, elimination, death, and intermittent attrition (IA; missing surveys) over nine months of follow-up); child/teenager self-report rates; and, reasons to enroll/participate. Over five years, of the 339 identified patients, 231 were eligible (in 22, we could not verify eligibility); 84 eligible patients were not approached and 43 declined participation. Patients not approached were more likely to die or have brain tumors. We enrolled 104 patients. Average enrollment rate was one patient per site per month; shortening follow-up from nine to three months (with optional re-enrollment) increased recruitment by 20%. A total of 87 patients completed the study (24 died) and 17 dropped out. Median IA was 41% in the first 20 weeks of follow-up and more than 60% in the eight weeks preceding death. Child/teenager self-report was 94%. Helping others, low burden procedures, incentives, and staff attitude were frequent reasons to enroll/participate. A PPC-RCT in children with advanced cancer was feasible, post-inclusion retention adequate; many families participated for altruistic reasons. Strategies that may further PPC-RCT feasibility include: increasing target population through large multicenter studies, approaching sicker patients, preventing exclusion of certain patient groups, and improving data collection at end of life. Copyright © 2015 American Academy of Hospice and Palliative Medicine

  18. Feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: a phase II randomized controlled trial of a brief palliative care psychotherapy.

    Science.gov (United States)

    Hall, Sue; Goddard, Cassie; Opio, Diana; Speck, Peter; Higginson, Irene J

    2012-07-01

    A pilot study of Dignity Therapy conducted with hospice patients reported high levels of self-reported benefits of the psychotherapy. To assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce distress in older people in care homes. A randomized controlled open-label trial (ISRCTN37589515). 60 residents aged 65+ with no major cognitive impairment living in care homes in London, UK. Dignity Therapy, a brief palliative care psychotherapy. Potential effectiveness (dignity-related distress, depression, hopefulness, quality of life at baseline and 1 and 8-week follow-up); acceptability (residents' views on self-reported benefits of Dignity Therapy/the Dignity Therapy study); and feasibility (time taken to deliver the intervention). We randomized 60/755 (8%) residents: 29 - control, 31 - intervention. We found no significant differences between groups on measures of potential effectiveness at any time. There was a reduction in dignity-related distress across both groups (p = 0.026). The intervention group outperformed the control group on all the acceptability items at both follow-ups. Effect sizes (Cohen's d) ranged from small (0.25) to large (0.85). These were significant for feeling that Dignity Therapy/the Dignity Therapy study had made their life more meaningful at 2-week follow-up (p = 0.04), and that it would help their families at both follow-ups (p = 0.02 and p = 0.01, respectively). Although it was feasible to deliver the intervention in this setting, it took longer to complete than anticipated. Although Dignity Therapy took longer to deliver than expected, this intervention may be a way of enhancing the end-of-life experiences of residents.

  19. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    Directory of Open Access Journals (Sweden)

    Villanueva Elmer V

    2007-10-01

    Full Text Available Abstract Background Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT. The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU. The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial. Methods/design The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a training and delivery of IPT, or (b TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra

  20. Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index.

    Science.gov (United States)

    Alkon, Abbey; Crowley, Angela A; Neelon, Sara E Benjamin; Hill, Sherika; Pan, Yi; Nguyen, Viet; Rose, Roberta; Savage, Eric; Forestieri, Nina; Shipman, Linda; Kotch, Jonathan B

    2014-03-01

    To address the public health crisis of overweight and obese preschool-age children, the Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge, center-level nutrition and physical activity policies and practices, and children's body mass index (BMI). A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California, Connecticut, and North Carolina, including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old. The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants. Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents. Blinded research assistants reviewed each center's written health and safety policies, observed nutrition and physical activity practices, and measured randomly selected children's nutritional intake, physical activity, and height and weight pre- and post-intervention. Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge, policies, practices and age- and sex-specific standardized body mass index (zBMI), controlling for state, parent education, and poverty level. Results showed significant increases in providers' and parents' knowledge of nutrition and physical activity, center-level improvements in policies, and child-level changes in children's zBMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points. The NAP SACC intervention, as delivered by trained child health professionals such as child care

  1. A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: rationale and design.

    Science.gov (United States)

    Lambert, Sylvie D; Girgis, Afaf; Turner, Jane; McElduff, Patrick; Kayser, Karen; Vallentine, Paula

    2012-09-26

    Although it is known both patients' and partners' reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients' partners' reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples' illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD. In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1) Coping-Together or 2) a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety) and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping) will be assessed at baseline (before receiving study material) and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted. As partners' distress rates exceed not only population norms, but also those reported by patients themselves, it is imperative

  2. The feasibility of clinical endpoint trials in HIV infection in the highly active antiretroviral treatment (HAART) era

    DEFF Research Database (Denmark)

    Mocroft, A; Neaton, J; Bebchuk, J

    2006-01-01

    the assumptions used in designing ESPRIT, a large randomized clinical trial assessing the clinical benefit of interleukin-2 treatment in patients with HIV infection, to use EuroSIDA to mimic the inclusion criterion of ESPRIT in order to compare the observed event rate in ESPRIT with the projected rate in Euro......SIDA, and to project the required length of ESPRIT. METHODS: Patients in EuroSIDA who satisfied the ESPRIT recruitment criteria were selected. Patients were followed from baseline to new AIDS or death. RESULTS: The incidence of clinical progression in the selected EuroSIDA patients (N = 4482) was 1.5 per 100 PYFU (95......% CI 1.3-1.7), and did not increase with increasing time from baseline, contrary to what was assumed in the design of the ESPRIT trial. In ESPRIT (N = 4150), for which the comparative data remain blinded, the incidence was 1.1 per 100 PYFU (95% CI 0.9-1.3), with no increase over time. The average...

  3. A single center analysis of factors influencing study start-up timeline in clinical trials.

    Science.gov (United States)

    Krafcik, Brianna M; Doros, Gheorghe; Malikova, Marina A

    2017-11-01

    Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. The start-up milestones were assessed for 38 studies and analyzed. Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

  4. Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial.

    Science.gov (United States)

    Gilchrist, Gail; Swan, Davina; Shaw, April; Keding, Ada; Towers, Sarah; Craine, Noel; Munro, Alison; Hughes, Elizabeth; Parrott, Steve; Mdege, Noreen; Strang, John; Taylor, Avril; Watson, Judith

    2017-11-01

    Opioid substitution therapy and needle exchanges have reduced blood-borne viruses (BBVs) among people who inject drugs (PWID). Some PWID continue to share injecting equipment. To develop an evidence-based psychosocial intervention to reduce BBV risk behaviours and increase transmission knowledge among PWID, and conduct a feasibility trial among PWID comparing the intervention with a control. A pragmatic, two-armed randomised controlled, open feasibility trial. Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London. NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York, recruiting January and February 2016. Current PWID, aged ≥ 18 years. A remote, web-based computer randomisation system allocated participants to a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU) (intervention), or information booklet plus TAU (control). Recruitment, retention and follow-up rates measured feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention's acceptability. A systematic review of what works to reduce BBV risk behaviours among PWID; in-depth interviews with PWID; and stakeholder and expert consultation informed the intervention. Sessions covered improving injecting technique and good vein care; planning for risky situations; and understanding BBV transmission. Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 24% (8/34) of male and 11% (2/18) of female participants attended all three intervention sessions. Overall, 50% (17/34) of men and 33% (6/18) of women randomised to the intervention group and 47% (14/30) of men and 53% (9/17) of women randomised to the

  5. Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers

    Directory of Open Access Journals (Sweden)

    Porchia Rich

    2017-07-01

    Full Text Available Abstract Background As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. Methods/design The Peer Empowerment Program 4 Physical Activity’ (PEP4PA is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit, adoption & penetration (reach, fidelity (quantity & quality of intervention delivered, acceptability (satisfaction, costs, and sustainability. Discussion Using a peer led implementation strategy to deliver a multi-level community based PA

  6. Testing the Feasibility of Remote Patient Monitoring in Prenatal Care Using a Mobile App and Connected Devices: A Prospective Observational Trial.

    Science.gov (United States)

    Marko, Kathryn I; Krapf, Jill M; Meltzer, Andrew C; Oh, Julia; Ganju, Nihar; Martinez, Anjali G; Sheth, Sheetal G; Gaba, Nancy D

    2016-11-18

    Excessive weight gain and elevated blood pressure are significant risk factors for adverse pregnancy outcomes such as gestational diabetes, premature birth, and preeclampsia. More effective strategies to facilitate adherence to gestational weight gain goals and monitor blood pressure may have a positive health benefit for pregnant women and their babies. The impact of utilizing a remote patient monitoring system to monitor blood pressure and weight gain as a component of prenatal care has not been previously assessed. The objective of this study is to determine the feasibility of monitoring patients remotely in prenatal care using a mobile phone app and connected digital devices. In this prospective observational study, 8 women with low risk pregnancy in the first trimester were recruited at an urban academic medical center. Participants received a mobile phone app with a connected digital weight scale and blood pressure cuff for at-home data collection for the duration of pregnancy. At-home data was assessed for abnormal values of blood pressure or weight to generate clinical alerts to the patient and provider. As measures of the feasibility of the system, participants were studied for engagement with the app, accuracy of remote data, efficacy of alert system, and patient satisfaction. Patient engagement with the mobile app averaged 5.5 times per week over the 6-month study period. Weight data collection and blood pressure data collection averaged 1.5 times and 1.1 times per week, respectively. At-home measurements of weight and blood pressure were highly accurate compared to in-office measurements. Automatic clinical alerts identified two episodes of abnormal weight gain with no false triggers. Patients demonstrated high satisfaction with the system. In this pilot study, we demonstrated that a system using a mobile phone app coupled to remote monitoring devices is feasible for prenatal care.

  7. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial.

    Science.gov (United States)

    Koniak-Griffin, Deborah; Brecht, Mary-Lynn; Takayanagi, Sumiko; Villegas, Juan; Melendrez, Marylee; Balcázar, Héctor

    2015-01-01

    Low-income Latinas (Hispanics) face risk for cardiovascular disease due to high rates of overweight/obesity, sedentary lifestyle, and other factors. Limited access to health care and language barriers may prevent delivery of health promotion messages. Targeted approaches, including the integration of community health workers, may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups. The term commonly used to refer to female community health workers in Latino communities is "promotora(s)." This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight, immigrant Latinas. A community prevention model was employed in planning and implementing this study. A randomized controlled trial design was used. A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance. The sample was comprised of 223 women aged 35-64 years, predominantly with low income and ≤8th grade education. The culturally tailored Lifestyle Behavior Intervention included group education (8 classes based upon Su Corazon, Su Vida), followed by 4 months of individual teaching and coaching (home visits and telephone calls). The control group received a comparable length educational program and follow-up contacts. Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire, accelerometer readings of physical activity, and clinical measures (body mass index, weight, waist circumference, blood pressure, lipids, blood glucose). Data were collected between January 2010 and August 2012. Women in the intervention group improved significantly in dietary habits, waist circumference, and physical activity in comparison to those in the control group. A treatment dosage effect was observed for weight and waist circumference. Knowledge about heart disease increased. High attendance at classes and

  8. The Feasibility of Real-Time Intraoperative Performance Assessment With SIMPL (System for Improving and Measuring Procedural Learning): Early Experience From a Multi-institutional Trial.

    Science.gov (United States)

    Bohnen, Jordan D; George, Brian C; Williams, Reed G; Schuller, Mary C; DaRosa, Debra A; Torbeck, Laura; Mullen, John T; Meyerson, Shari L; Auyang, Edward D; Chipman, Jeffrey G; Choi, Jennifer N; Choti, Michael A; Endean, Eric D; Foley, Eugene F; Mandell, Samuel P; Meier, Andreas H; Smink, Douglas S; Terhune, Kyla P; Wise, Paul E; Soper, Nathaniel J; Zwischenberger, Joseph B; Lillemoe, Keith D; Dunnington, Gary L; Fryer, Jonathan P

    Intraoperative performance assessment of residents is of growing interest to trainees, faculty, and accreditors. Current approaches to collect such assessments are limited by low participation rates and long delays between procedure and evaluation. We deployed an innovative, smartphone-based tool, SIMPL (System for Improving and Measuring Procedural Learning), to make real-time intraoperative performance assessment feasible for every case in which surgical trainees participate, and hypothesized that SIMPL could be feasibly integrated into surgical training programs. Between September 1, 2015 and February 29, 2016, 15 U.S. general surgery residency programs were enrolled in an institutional review board-approved trial. SIMPL was made available after 70% of faculty and residents completed a 1-hour training session. Descriptive and univariate statistics analyzed multiple dimensions of feasibility, including training rates, volume of assessments, response rates/times, and dictation rates. The 20 most active residents and attendings were evaluated in greater detail. A total of 90% of eligible users (1267/1412) completed training. Further, 13/15 programs began using SIMPL. Totally, 6024 assessments were completed by 254 categorical general surgery residents (n = 3555 assessments) and 259 attendings (n = 2469 assessments), and 3762 unique operations were assessed. There was significant heterogeneity in participation within and between programs. Mean percentage (range) of users who completed ≥1, 5, and 20 assessments were 62% (21%-96%), 34% (5%-75%), and 10% (0%-32%) across all programs, and 96%, 75%, and 32% in the most active program. Overall, response rate was 70%, dictation rate was 24%, and mean response time was 12 hours. Assessments increased from 357 (September 2015) to 1146 (February 2016). The 20 most active residents each received mean 46 assessments by 10 attendings for 20 different procedures. SIMPL can be feasibly integrated into surgical training programs

  9. Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial.

    Science.gov (United States)

    Kingston, Dawn; Austin, Marie-Paule; Veldhuyzen van Zanten, Sander; Harvalik, Paula; Giallo, Rebecca; McDonald, Sarah D; MacQueen, Glenda; Vermeyden, Lydia; Lasiuk, Gerri; Sword, Wendy; Biringer, Anne

    2017-04-07

    Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges. The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns. Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at Ppaper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e

  10. A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: Study protocol

    Directory of Open Access Journals (Sweden)

    Richardson Alison

    2009-03-01

    Full Text Available Abstract Background Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. Methods/design A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i Intervention (Dignity Therapy offered in addition to any standard care, and (ii Control group (standard care. Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group. The primary outcome is residents' sense of dignity (potential effectiveness assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if

  11. Breast cancer risk reduction--is it feasible to initiate a randomised controlled trial of a lifestyle intervention programme (ActWell) within a national breast screening programme?

    Science.gov (United States)

    Anderson, Annie S; Macleod, Maureen; Mutrie, Nanette; Sugden, Jacqueline; Dobson, Hilary; Treweek, Shaun; O'Carroll, Ronan E; Thompson, Alistair; Kirk, Alison; Brennan, Graham; Wyke, Sally

    2014-12-17

    Breast cancer is the most commonly diagnosed cancer and the second cause of cancer deaths amongst women in the UK. The incidence of the disease is increasing and is highest in women from least deprived areas. It is estimated that around 42% of the disease in post-menopausal women could be prevented by increased physical activity and reductions in alcohol intake and body fatness. Breast cancer control endeavours focus on national screening programmes but these do not include communications or interventions for risk reduction. This study aimed to assess the feasibility of delivery, indicative effects and acceptability of a lifestyle intervention programme initiated within the NHS Scottish Breast Screening Programme (NHSSBSP). A 1:1 randomised controlled trial (RCT) of the 3 month ActWell programme (focussing on body weight, physical activity and alcohol) versus usual care conducted in two NHSSBSP sites between June 2013 and January 2014. Feasibility assessments included recruitment, retention, and fidelity to protocol. Indicative outcomes were measured at baseline and 3 month follow-up (body weight, waist circumference, eating and alcohol habits and physical activity). At study end, a questionnaire assessed participant satisfaction and qualitative interviews elicited women's, coaches, and radiographers' experiences. Statistical analysis used Chi squared tests for comparisons in proportions and paired t tests for comparisons of means. Linear regression analyses were performed, adjusted for baseline values, with group allocation as a fixed effect. A pre-set recruitment target of 80 women was achieved within 12 weeks and 65 (81%) participants (29 intervention, 36 control) completed 3 month assessments. Mean age was 58 ± 5.6 years, mean BMI was 29.2 ± 7.0 kg/m(2) and many (44%) reported a family history of breast cancer. The primary analysis (baseline body weight adjusted) showed a significant between group difference favouring the intervention group of 2.04 kg

  12. Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

    Directory of Open Access Journals (Sweden)

    Laurier Claudine

    2011-01-01

    Full Text Available Abstract Background The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care. Methods A pilot clustered randomised trial was conducted. Family medicine groups (FMGs were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program. Results Among 21 FMGs contacted, 5 (24% agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group, and the overall mean level of satisfaction regarding the workshops was 94%. Conclusions This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians

  13. [Semi-structured interviews on suicidality in the Hamburg pre-trial detention center].

    Science.gov (United States)

    Djerkovic, Dijana; Jasker, Janine; Kunze-Klempert, Sabrina; Morick, Yvonne; Thiel, Andreas; Briken, Peer; Klaus Püschell

    2014-01-01

    A detailed study regarding inmates' suicides was conducted in the detention center of Holstenglacis Hamburg (UHA). This study was triggered by an above-average number of attempted and committed suicides in detention centers in Germany and in particular, two committed suicides in the above-mentioned prison in early 2012. In this qualitative empirical study, 20 semi-structured interviews were conducted with inmates and staff of the UHA Hamburg. The focus was placed on aspects encountered in the daily life within the detention center and stressful situations that could encourage suicides. This article presents the most striking results of the study which are used as a basis for proposing several preventative measures. The aim of this article is to present new ideas and methods conducive to a decrease in the number of suicides in detention centers at minimal costs and personnel expenses.

  14. Systematic review of clinical trials assessing the therapeutic efficacy of visceral leishmaniasis treatments: A first step to assess the feasibility of establishing an individual patient data sharing platform.

    Directory of Open Access Journals (Sweden)

    Jacob T Bush

    2017-09-01

    Full Text Available There are an estimated 200,000 to 400,000 cases of visceral leishmaniasis (VL annually. A variety of factors are taken into account when considering the best therapeutic options to cure a patient and reduce the risk of resistance, including geographical area, malnourishment and HIV coinfection. Pooled analyses combine data from many studies to answer specific scientific questions that cannot be answered with individual studies alone. However, the heterogeneity of study design, data collection, and analysis often makes direct comparison difficult. Individual Participant Data (IPD files can be standardised and analysed, allowing detailed analysis of this merged larger pool, but only a small fraction of systematic reviews and meta-analyses currently employ pooled analysis of IPD. We conducted a systematic literature review to identify published studies and studies reported in clinical trial registries to assess the feasibility of developing a VL data sharing platform to facilitate an IPD-based analysis of clinical trial data. Studies conducted between 1983 to 2015 that reported treatment outcome were eligible.From the 2,271 documents screened, 145 published VL clinical trials were identified, with data from 26,986 patients. Methodologies varied for diagnosis and treatment outcomes, but overall the volume of data potentially available on different drugs and dose regimens identified hundreds or possibly thousands of patients per arm suitable for IPD pooled meta-analyses.A VL data sharing platform would provide an opportunity to maximise scientific use of available data to enable assessment of treatment efficacy, contribute to evidence-based clinical management and guide optimal prospective data collection.

  15. A feasibility trial to examine the social norms approach for the prevention and reduction of licit and illicit drug use in European University and college students

    Directory of Open Access Journals (Sweden)

    Pischke Claudia R

    2012-10-01

    Full Text Available Abstract Background Incorrect perceptions of high rates of peer alcohol and tobacco use are predictive of increased personal use in student populations. Correcting misperceptions by providing feedback has been shown to be an effective intervention for reducing licit drug use. It is currently unknown if social norms interventions are effective in preventing and reducing illicit drug use in European students. The purpose of this paper is to describe the design of a multi-site cluster controlled trial of a web-based social norms intervention aimed at reducing licit and preventing illicit drug use in European university students. Methods/Design An online questionnaire to assess rates of drug use will be developed and translated based on existing social norms surveys. Students from sixteen universities in seven participating European countries will be invited to complete the questionnaire. Both intervention and control sites will be chosen by convenience. In each country, the intervention site will be the university that the local principal investigator is affiliated with. We aim to recruit 1000 students per site (baseline assessment. All participants will complete the online questionnaire at baseline. Baseline data will be used to develop social norms messages that will be included in a web-based intervention. The intervention group will receive individualized social norms feedback. The website will remain online during the following 5 months. After five months, a second survey will be conducted and effects of the intervention on social norms and drug use will be measured in comparison to the control site. Discussion This project is the first cross-national European collaboration to investigate the feasibility of a social norms intervention to reduce licit and prevent illicit drug use among European university students. Final trial registration number DRKS00004375 on the ‘German Clinical Trials Register’.

  16. Camino Verde (The Green Way: evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract Background Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate, in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. Methods/Design The Camino Verde (Green Way is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137–140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3–9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples and entomological indices between intervention and control sites. Discussion Our hypothesis is that

  17. Systematic review of clinical trials assessing the therapeutic efficacy of visceral leishmaniasis treatments: A first step to assess the feasibility of establishing an individual patient data sharing platform.

    Science.gov (United States)

    Bush, Jacob T; Wasunna, Monique; Alves, Fabiana; Alvar, Jorge; Olliaro, Piero L; Otieno, Michael; Sibley, Carol Hopkins; Strub Wourgaft, Nathalie; Guerin, Philippe J

    2017-09-01

    There are an estimated 200,000 to 400,000 cases of visceral leishmaniasis (VL) annually. A variety of factors are taken into account when considering the best therapeutic options to cure a patient and reduce the risk of resistance, including geographical area, malnourishment and HIV coinfection. Pooled analyses combine data from many studies to answer specific scientific questions that cannot be answered with individual studies alone. However, the heterogeneity of study design, data collection, and analysis often makes direct comparison difficult. Individual Participant Data (IPD) files can be standardised and analysed, allowing detailed analysis of this merged larger pool, but only a small fraction of systematic reviews and meta-analyses currently employ pooled analysis of IPD. We conducted a systematic literature review to identify published studies and studies reported in clinical trial registries to assess the feasibility of developing a VL data sharing platform to facilitate an IPD-based analysis of clinical trial data. Studies conducted between 1983 to 2015 that reported treatment outcome were eligible. From the 2,271 documents screened, 145 published VL clinical trials were identified, with data from 26,986 patients. Methodologies varied for diagnosis and treatment outcomes, but overall the volume of data potentially available on different drugs and dose regimens identified hundreds or possibly thousands of patients per arm suitable for IPD pooled meta-analyses. A VL data sharing platform would provide an opportunity to maximise scientific use of available data to enable assessment of treatment efficacy, contribute to evidence-based clinical management and guide optimal prospective data collection.

  18. Dynamic contrast-enhanced breast MRI at 7 Tesla utilizing a single-loop coil: a feasibility trial.

    Science.gov (United States)

    Umutlu, Lale; Maderwald, Stefan; Kraff, Oliver; Theysohn, Jens M; Kuemmel, Sherko; Hauth, Elke A; Forsting, Michael; Antoch, Gerald; Ladd, Mark E; Quick, Harald H; Lauenstein, Thomas C

    2010-08-01

    The aim of this study was to assess the feasibility of dynamic contrast-enhanced ultra-high-field breast imaging at 7 Tesla. A total of 15 subjects, including 5 patients with histologically proven breast cancer, were examined on a 7 Tesla whole-body magnetic resonance imaging system using a unilateral linearly polarized single-loop coil. Subjects were placed in prone position on a biopsy support system, with the coil placed directly below the region of interest. The examination protocol included the following sequences: 1) T2-weighted turbo spin echo sequence; 2) six dynamic T1-weighted spoiled gradient-echo sequences; and 3) subtraction imaging. Contrast-enhanced T1-weighted imaging at 7 Tesla could be obtained at high spatial resolution with short acquisition times, providing good image accuracy and a conclusively good delineation of small anatomical and pathological structures. T2-weighted imaging could be obtained with high spatial resolution at adequate acquisition times. Because of coil limitations, four high-field magnetic resonance examinations showed decreased diagnostic value. This first scientific approach of dynamic contrast-enhanced breast magnetic resonance imaging at 7 Tesla demonstrates the complexity of ultra-high-field breast magnetic resonance imaging and countenances the implementation of further advanced bilateral coil concepts to circumvent current limitations from the coil and ultra-high-field magnetic strength. 2010 AUR. Published by Elsevier Inc. All rights reserved.

  19. Examining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial.

    Science.gov (United States)

    Chan, Ramony; Dear, Blake F; Titov, Nick; Chow, Josephine; Suranyi, Michael

    2016-10-01

    Treating depression among patients with chronic kidney disease (CKD) is imperative because of its high prevalence and health-related costs. However, many patients with CKD experience significant barriers to effective face-to-face psychological treatments. Internet-delivered cognitive behaviour therapy (iCBT) may help overcome the treatment barriers. The aim of the present study was to explore the acceptability and preliminary efficacy of iCBT for depression and anxiety among patients with CKD on haemodialysis. A single-group open trial design involving 22 patients on dialysis and an established iCBT treatment for anxiety and depression was employed. The primary outcomes were symptoms of depression, anxiety and general psychological distress. The secondary and tertiary outcomes were disability, quality of life, kidney disease-related loss and kidney disease burden. A generalised estimation equation modelling technique was employed. Clinically significant improvements (avg. % of improvement) were observed in the primary outcomes of depression (34%), anxiety (31%) and general distress (26%), which were maintained or further improved to 3-month follow-up. Improvements were also observed for quality of life (12%) and kidney disease-related loss (30%). However, no improvements in disability and kidney disease burden were found. High levels of acceptability were reported and relatively little clinician time (99.45min; SD=14.61) was needed to provide the treatment. The present results provide encouraging support for the potential of iCBT as an innovative way of increasing access to effective psychological treatment for CKD patients. These results provide much needed support for further research in this area. Australian and New Zealand Clinical Trials Registry: ACTRN12613000103763. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

    2017-03-29

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be

  1. Simultaneous recording of MEG, EEG and intracerebral EEG during visual stimulation: from feasibility to single-trial analysis.

    Science.gov (United States)

    Dubarry, Anne-Sophie; Badier, Jean-Michel; Trébuchon-Da Fonseca, Agnès; Gavaret, Martine; Carron, Romain; Bartolomei, Fabrice; Liégeois-Chauvel, Catherine; Régis, Jean; Chauvel, Patrick; Alario, F-Xavier; Bénar, Christian-G

    2014-10-01

    Electroencephalography (EEG), magnetoencephalography (MEG), and intracerebral stereotaxic EEG (SEEG) are the three neurophysiological recording techniques, which are thought to capture the same type of brain activity. Still, the relationships between non-invasive (EEG, MEG) and invasive (SEEG) signals remain to be further investigated. In early attempts at comparing SEEG with either EEG or MEG, the recordings were performed separately for each modality. However such an approach presents substantial limitations in terms of signal analysis. The goal of this technical note is to investigate the feasibility of simultaneously recording these three signal modalities (EEG, MEG and SEEG), and to provide strategies for analyzing this new kind of data. Intracerebral electrodes were implanted in a patient with intractable epilepsy for presurgical evaluation purposes. This patient was presented with a visual stimulation paradigm while the three types of signals were simultaneously recorded. The analysis started with a characterization of the MEG artifact caused by the SEEG equipment. Next, the average evoked activities were computed at the sensor level, and cortical source activations were estimated for both the EEG and MEG recordings; these were shown to be compatible with the spatiotemporal dynamics of the SEEG signals. In the average time-frequency domain, concordant patterns between the MEG/EEG and SEEG recordings were found below the 40 Hz level. Finally, a fine-grained coupling between the amplitudes of the three recording modalities was detected in the time domain, at the level of single evoked responses. Importantly, these correlations have shown a high level of spatial and temporal specificity. These findings provide a case for the ability of trimodal recordings (EEG, MEG, and SEEG) to reach a greater level of specificity in the investigation of brain signals and functions. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants.

    Science.gov (United States)

    Ruggeri, Mirella; Bonetto, Chiara; Lasalvia, Antonio; Fioritti, Angelo; de Girolamo, Giovanni; Santonastaso, Paolo; Pileggi, Francesca; Neri, Giovanni; Ghigi, Daniela; Giubilini, Franco; Miceli, Maurizio; Scarone, Silvio; Cocchi, Angelo; Torresani, Stefano; Faravelli, Carlo; Cremonese, Carla; Scocco, Paolo; Leuci, Emanuela; Mazzi, Fausto; Pratelli, Michela; Bellini, Francesca; Tosato, Sarah; De Santi, Katia; Bissoli, Sarah; Poli, Sara; Ira, Elisa; Zoppei, Silvia; Rucci, Paola; Bislenghi, Laura; Patelli, Giovanni; Cristofalo, Doriana; Meneghelli, Anna

    2015-09-01

    Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research

  3. Validation of a novel behavior prediction scale: A two-center trial

    Directory of Open Access Journals (Sweden)

    Sharath Asokan

    2014-01-01

    Aim: This study was planned to evaluate and validate a specially prepared questionnaire as a child behavior prediction scale. Design: A two-center cross-sectional study was done to validate the new scale. Materials and Methods: Children aged 3-12 years (n = 296, from two different centers participated in this study. The questionnaire used was a 10-point observational scale. Observations involved perceiving overt and subtle behavioral characteristics of a child, to assess the child′s behavior in the dental office before treatment. An independent observer approached the children and their parents in the waiting room. The child′s behavior was then evaluated by the dentist using Frankl behavior rating scale during and after treatment. The prediction of behavior compared to the Frankl scale was assessed and validated. Statistical Analysis: Sensitivity, specificity tests, and receiver operating curve analysis were used to validate the new scale and calculate the cut-off score for positive and negative behavior. All data were processed by SPSS software (16.0, SPSS Inc., Chicago, Ill, USA. Results: The best cut-off score to predict a positive Frankl rating was ≥ 8.0 in both the centers. The sensitivity and specificity scores were 93.4% and 62.5% in center 1; 83.1% and 59.6% in center 2 respectively. Conclusion: This novel prediction scale can be of great importance in predicting children′s behavior in the dental environment.

  4. The feasibility of randomized controlled trials for early arthritis therapies (Earth) involving acute anterior cruciate ligament tear cohorts.

    Science.gov (United States)

    Chu, Constance R; Beynnon, Bruce D; Dragoo, Jason L; Fleisig, Glenn S; Hart, Joseph M; Khazzam, Michael; Marberry, Kevin M; Nelson, Bradley J

    2012-11-01

    Osteoarthritis (OA) is a leading cause of disability for which disease-modifying treatments are lacking. Anterior cruciate ligament (ACL) tear provides opportunities to study potential interventions from the initiation of heightened OA risk at the time of injury. This institutional review board (IRB)-approved prospective cross-sectional study (level of evidence: 2) was performed to test the hypothesis that adequate sample sizes of ACL-injured subjects to support randomized controlled trials (RCT) of early intervention strategies can be achieved. A total of 307 ACL-injured patients were entered into the database from 3-month collection periods at 7 clinical sites, with 65 subjects aged 18 to 30 years passing the inclusion/exclusion criteria. From sites that were IRB approved to ask, 89 of 96 (93%) subjects were willing to participate in an RCT. Extrapolating the 3-month data to a 1-year recruitment period would potentially yield 242 subjects aged 18 to 30 years willing to undergo randomization. This study shows that adequate sample sizes to perform RCT of early intervention strategies in ACL-injured cohorts comprising healthy young adults ages 18 to and 30 without prior joint injuries can be achieved within 1 to 2 years through recruitment at 5 to 7 orthopaedic sports medicine practices. Continued development of ACL-tear cohorts will provide the clinical base to critically evaluate new diagnostic and therapeutic strategies that can help transform clinical care of OA from palliation to prevention.

  5. Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial.

    Science.gov (United States)

    Berman, Margit I; Buckey, Jay C; Hull, Jay G; Linardatos, Eftihia; Song, Sueyoung L; McLellan, Robert K; Hegel, Mark T

    2014-05-01

    Computer-based depression interventions lacking live therapist support have difficulty engaging users. This study evaluated the usability, acceptability, credibility, therapeutic alliance and efficacy of a stand-alone multimedia, interactive, computer-based Problem Solving Treatment program (ePST™) for depression. The program simulated live treatment from an expert PST therapist, and delivered 6 ePST™ sessions over 9weeks. Twenty-nine participants with moderate-severe symptoms received the intervention; 23 completed a minimally adequate dose of ePST™ (at least 4 sessions). Program usability, acceptability, credibility, and therapeutic alliance were assessed at treatment midpoint and endpoint. Depressive symptoms and health-related functioning were assessed at baseline, treatment midpoint (4weeks), and study endpoint (10weeks). Depression outcomes and therapeutic alliance ratings were also compared to previously published research on live PST and computer-based depression therapy. Participants rated the program as highly usable, acceptable, and credible, and reported a therapeutic alliance with the program comparable to that observed in live therapy. Depressive symptoms improved significantly over time. These findings also provide preliminary evidence that ePST™ may be effective as a depression treatment. Larger clinical trials with diverse samples are indicated. Copyright © 2014. Published by Elsevier Ltd.

  6. Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial.

    Science.gov (United States)

    Prescher, Sandra; Deckwart, Oliver; Winkler, Sebastian; Koehler, Kerstin; Honold, Marcus; Koehler, Friedrich

    2013-06-01

    The randomized Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial (NCT00543881) was performed during 2008 and 2010 to determine whether physician-led remote patient management (RPM) compared with usual care would result in reduced mortality and morbidity in stable out-patient heart failure (HF) patients. However, besides results of clinical benefit, the acceptance by patients and primary physicians is necessary for the implementation of RPM as part of the upcoming out-patient HF-care programs. Two months after finishing of the trial, a survey based analysis of the perception of telemedical care with patients (n=288) and primary physicians (n=102) was carried out. The survey included questions regarding self-management, usability and physician-patient communication. The concept of RPM was perceived positively by patients and physicians. The devices were assessed as easy to use (98.6%, n=224) and robust (88.8%, n=202). Through trial participation and daily measurements most of the patients (85.5%, n=195) felt more confident in dealing with their disease than before. The perception of the nurses and physicians of the telemedical centers was professional (92.1%, n=210 and 89.9%, n=205) and committed (94.3%, n=215 and 91.7%, n=209). Also more than half of the patients noticed an improvement in the contact with their primary physician (52.6%, n=120); and for 46.1% (n=105) the contact has not been changed. RPM will be a medical care concept for recently hospitalized HF- patients in the near future but the optimal telemedical setting of RPM and the duration of this intervention have to be defined in further clinical trials.

  7. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': a feasibility study PEACH trial: prescribed exercise after chemotherapy.

    LENUS (Irish Health Repository)

    Walsh, Julie M

    2010-01-01

    BACKGROUND: Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. METHODS\\/DESIGN: The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks), at the end of the intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. DISCUSSION: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy.

  8. Tuning the light in senior care: Evaluating a trial LED lighting system at the ACC Care Center in Sacramento, CA

    Energy Technology Data Exchange (ETDEWEB)

    Davis, Robert G.; Wilkerson, Andrea M.; Samla, Connie; Bisbee, Dave

    2016-08-31

    This report summarizes the results from a trial installation of light-emitting diode (LED) lighting systems in several spaces within the ACC Care Center in Sacramento, CA. The Sacramento Municipal Utility District (SMUD) coordinated the project and invited the U.S. Department of Energy (DOE) to document the performance of the LED lighting systems as part of a GATEWAY evaluation. DOE tasked the Pacific Northwest National Laboratory (PNNL) to conduct the investigation. SMUD and ACC staff coordinated and completed the design and installation of the LED systems, while PNNL and SMUD staff evaluated the photometric performance of the systems. ACC staff also track behavioral and health measures of the residents; some of those results are reported here, although PNNL staff were not directly involved in collecting or interpreting those data. The trial installation took place in a double resident room and a single resident room, and the corridor that connects those (and other) rooms to the central nurse station. Other spaces in the trial included the nurse station, a common room called the family room located near the nurse station, and the ACC administrator’s private office.

  9. Feasibility of a real-time self-monitoring device for sitting less and moving more: a randomised controlled trial.

    Science.gov (United States)

    Martin, Anne; Adams, Jacob M; Bunn, Christopher; Gill, Jason M R; Gray, Cindy M; Hunt, Kate; Maxwell, Douglas J; van der Ploeg, Hidde P; Wyke, Sally; Mutrie, Nanette

    2017-01-01

    Time spent inactive and sedentary are both associated with poor health. Self-monitoring of walking, using pedometers for real-time feedback, is effective at increasing physical activity. This study evaluated the feasibility of a new pocket-worn sedentary time and physical activity real-time self-monitoring device (SitFIT). Forty sedentary men were equally randomised into two intervention groups. For 4 weeks, one group received a SitFIT providing feedback on steps and time spent sedentary (lying/sitting); the other group received a SitFIT providing feedback on steps and time spent upright (standing/stepping). Change in sedentary time, standing time, stepping time and step count was assessed using activPAL monitors at baseline, 4-week follow-up (T1) and 12-week (T2) follow-up. Semistructured interviews were conducted after 4 and 12 weeks. The SitFIT was reported as acceptable and usable and seen as a motivating tool to reduce sedentary time by both groups. On average, participants reduced their sedentary time by 7.8 minutes/day (95% CI -55.4 to 39.7) (T1) and by 8.2 minutes/day (95% CI -60.1 to 44.3) (T2). They increased standing time by 23.2 minutes/day (95% CI 4.0 to 42.5) (T1) and 16.2 minutes/day (95% CI -13.9 to 46.2) (T2). Stepping time was increased by 8.5 minutes/day (95% CI 0.9 to 16.0) (T1) and 9.0 minutes/day (95% CI 0.5 to 17.5) (T2). There were no between-group differences at either follow-up time points. The SitFIT was perceived as a useful tool for self-monitoring of sedentary time. It has potential as a real-time self-monitoring device to reduce sedentary and increase upright time.

  10. Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT³VIN): a multicentre, open-label, randomised, phase 2 trial.

    Science.gov (United States)

    Tristram, Amanda; Hurt, Christopher N; Madden, Tracie; Powell, Ned; Man, Stephen; Hibbitts, Sam; Dutton, Peter; Jones, Sadie; Nordin, Andrew J; Naik, Raj; Fiander, Alison; Griffiths, Gareth

    2014-11-01

    Vulval intraepithelial neoplasia is a skin disorder affecting the vulva that, if left untreated, can become cancerous. Currently, the standard treatment for patients with vulval intraepithelial neoplasia is surgery, but this approach does not guarantee cure and can be disfiguring, causing physical and psychological problems, particularly in women of reproductive age. We aimed to assess the activity, safety, and feasibility of two topical treatments--cidofovir and imiquimod--as an alternative to surgery in female patients with vulval intraepithelial neoplasia. We recruited female patients (age 16 years or older) from 32 centres to an open-label, randomised, phase 2 trial. Eligibility criteria were biopsy-proven vulval intraepithelial neoplasia grade 3 and at least one lesion that could be measured accurately. We randomly allocated patients to topical treatment with either 1% cidofovir (supplied as a gel in a 10 g tube, to last 6 weeks) or 5% imiquimod (one 250 mg sachet for every application), to be self-applied three times a week for a maximum of 24 weeks. Randomisation (1:1) was done by stratified minimisation via a central computerised system, with stratification by hospital, disease focality, and presentation stage. The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit 6 weeks after the end of treatment (a maximum of 30 weeks after treatment started). Analysis of the primary endpoint was by intention to treat. Secondary outcomes were toxic effects (to assess safety) and adherence to treatment (to assess feasibility). We present results after all patients had reached the primary endpoint assessment point at 6 weeks; 2-year follow-up of complete responders continues. This trial is registered with Current Controlled Trials, ISRCTN 34420460. Between Oct 21, 2009, and Jan 11, 2013, 180 participants were enrolled to the study; 89 patients were randomly allocated cidofovir and 91 were assigned imiquimod. At the

  11. The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

    Science.gov (United States)

    Berry, Donna L; Halpenny, Barbara; Hong, Fangxin; Wolpin, Seth; Lober, William B; Russell, Kenneth J; Ellis, William J; Govindarajulu, Usha; Bosco, Jaclyn; Davison, B Joyce; Bennett, Gerald; Terris, Martha K; Barsevick, Andrea; Lin, Daniel W; Yang, Claire C; Swanson, Greg

    2013-10-01

    The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of

  12. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

    Directory of Open Access Journals (Sweden)

    Kristen L Hollands

    Full Text Available Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke.This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services.Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments.Over-ground visual cue training (O-VCT, Treadmill based visual cue training (T-VCT, and Usual care (UC delivered by physiotherapists twice weekly for 8 weeks.Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up.Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC. Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms.Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention.Clinicaltrials.gov NCT01600391.

  13. A pilot randomised controlled trial to evaluate the feasibility and acceptability of the Baby Triple P Positive Parenting Programme in mothers with postnatal depression.

    Science.gov (United States)

    Tsivos, Zoe-Lydia; Calam, Rachel; Sanders, Matthew R; Wittkowski, Anja

    2015-10-01

    Few interventions for Postnatal Depression (PND) have focused on parenting difficulties; the aim of this research was to investigate the feasibility and evaluate a parenting intervention (Baby Triple P) in women with PND. This was a pilot randomised controlled trial (RCT) to evaluate and determine the feasibility of the newly developed Baby Triple P compared with treatment as usual (TAU) in women with PND. In all, 27 female participants aged from 18 to 45 years (mean age = 28.4 years, standard deviation (SD) = 6.1), with a primary diagnosis of major depression and an infant under 12 months (mean age = 6.2 months, SD = 3.2 months), were recruited from primary care trusts in Greater Manchester, United Kingdom. Participants were randomly allocated to receive either eight Baby Triple P sessions in addition to TAU or TAU only. Outcomes were assessed at post-treatment (Time 2) and 3 months post-treatment (Time 3). Self-report outcomes were as follows: Beck Depression Inventory, Oxford Happiness Inventory, What Being the Parent of a New Baby is Like, Postpartum Bonding Questionnaire and the Brief Parenting Beliefs Scale-baby version. An assessor-rated observational measure of mother-infant interaction, the CARE Index and measure of intervention acceptability were also completed. Significant improvements from Time 1 to Time 2 and Time 1 to Time 3 were observed across both groups. Although women allocated to Baby Triple P showed more favourable improvements, the between-group differences were not significant. However, the intervention was highly acceptable to women with PND. A large-scale RCT is indicated. © The Author(s) 2014.

  14. A feasibility open trial of internet-delivered cognitive-behavioural therapy (iCBT among consumers of a non-governmental mental health organisation with anxiety

    Directory of Open Access Journals (Sweden)

    Terry Kirkpatrick

    2013-11-01

    Full Text Available Background. To date the efficacy and acceptability of internet-delivered cognitive behavioural treatments (iCBT has been examined in clinical trials and specialist facilities. The present study reports the acceptability, feasibility and preliminary efficacy of an established iCBT treatment course (the Wellbeing Course administered by a not-for-profit non-governmental organisation, the Mental Health Association (MHA of New South Wales, to consumers with symptoms of anxiety.Methods. Ten individuals who contacted the MHA’s telephone support line or visited the MHA’s website and reported at least mild symptoms of anxiety (GAD-7 total scores ≥5 were admitted to the study. Participants were provided access to the Wellbeing Course, which comprises five online lessons and homework assignments, and brief weekly support from an MHA staff member via telephone and email. The MHA staff member was an experienced mental health professional and received minimal training in administering the intervention.Results. All 10 participants completed the course within the 8 weeks. Post-treatment and two month follow-up questionnaires were completed by all participants. Mean within-group effect sizes (Cohen’s d for the Generalized Anxiety Disorder 7 Item (GAD-7 and Patient Health Questionnaire 9 Item (PHQ-9 were large (i.e., > .80 and consistent with previous controlled research. The Course was also rated as highly acceptable with all 10 participants reporting it was worth their time and they would recommend it to a friend.Conclusions. These results provide support for the potential clinical utility of iCBT interventions and the acceptability and feasibility of employing non-governmental mental health organisations to deliver these treatments. However, further research is needed to examine the clinical efficacy and cost-effectiveness of delivering iCBT via such organisations.

  15. Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

    Science.gov (United States)

    Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

    2016-01-01

    To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

  16. A feasibility open trial of internet-delivered cognitive-behavioural therapy (iCBT) among consumers of a non-governmental mental health organisation with anxiety.

    Science.gov (United States)

    Kirkpatrick, Terry; Manoukian, Linda; Dear, Blake F; Johnston, Luke; Titov, Nickolai

    2013-01-01

    Background. To date the efficacy and acceptability of internet-delivered cognitive behavioural treatments (iCBT) has been examined in clinical trials and specialist facilities. The present study reports the acceptability, feasibility and preliminary efficacy of an established iCBT treatment course (the Wellbeing Course) administered by a not-for-profit non-governmental organisation, the Mental Health Association (MHA) of New South Wales, to consumers with symptoms of anxiety. Methods. Ten individuals who contacted the MHA's telephone support line or visited the MHA's website and reported at least mild symptoms of anxiety (GAD-7 total scores ≥5) were admitted to the study. Participants were provided access to the Wellbeing Course, which comprises five online lessons and homework assignments, and brief weekly support from an MHA staff member via telephone and email. The MHA staff member was an experienced mental health professional and received minimal training in administering the intervention. Results. All 10 participants completed the course within the 8 weeks. Post-treatment and two month follow-up questionnaires were completed by all participants. Mean within-group effect sizes (Cohen's d) for the Generalized Anxiety Disorder 7 Item (GAD-7) and Patient Health Questionnaire 9 Item (PHQ-9) were large (i.e., > .80) and consistent with previous controlled research. The Course was also rated as highly acceptable with all 10 participants reporting it was worth their time and they would recommend it to a friend. Conclusions. These results provide support for the potential clinical utility of iCBT interventions and the acceptability and feasibility of employing non-governmental mental health organisations to deliver these treatments. However, further research is needed to examine the clinical efficacy and cost-effectiveness of delivering iCBT via such organisations.

  17. 'Thinking that somebody's going to delay [a tonsillectomy] for one to two years is quite horrifying really': a qualitative feasibility study for the NAtional Trial of Tonsillectomy IN Adults (NATTINA Part 2).

    Science.gov (United States)

    McSweeney, L A; O'Hara, J T; Rousseau, N S; Stocken, D D; Sullivan, F; Vale, L; Wilkes, S; Wilson, J A; Haighton, C A

    2017-06-01

    Level one evidence on the value of adult tonsillectomy versus non-surgical management remains scarce. Before embarking on a costly national randomised controlled trial, it is essential to establish its feasibility. Feasibility study with in-depth qualitative and cognitive interviews. ENT staff and patients were recruited from nine hospital centres across England and Scotland. Patients who were referred for tonsillectomy (n = 15), a convenience sample of general practitioners (n = 11) and ear, nose and throat staff (n = 22). To ascertain whether ear, nose and throat staff would be willing to randomise patients to the treatment arms. To assess general practitioners' willingness to refer patients to the NAtional Trial of Tonsillectomy IN Adults (NATTINA) centres. To assess patients' willingness to be randomised and the acceptability of the deferred surgery treatment arm. To ascertain whether the study could progress to the pilot trial stage. Ear, nose and throat staff and general practitioners were willing to randomise patients to the proposed NATTINA. Not all ENT staff were in equipoise concerning the treatment pathways. Patients were reluctant to be randomised into the deferred surgery group if they had already waited a substantial time before being referred. Findings suggest that the NATTINA may not be feasible. Proposed methods could not be realistically assessed without a pilot trial. Due to the importance of the question, as evidenced by NATTINA clinicians, and strong support from ENT staff, the pilot trial proceeded, with modifications. © 2016 John Wiley & Sons Ltd.

  18. A feasibility open trial of guided Internet-delivered cognitive behavioural therapy for anxiety and depression amongst Arab Australians

    Directory of Open Access Journals (Sweden)

    Rony Kayrouz

    2015-03-01

    Full Text Available The present study examined the preliminary efficacy and acceptability of a culturally modified therapist-guided cognitive behaviour therapy (CBT treatment for Arab Australians, aged 18 years and over with symptoms of depression and anxiety. To facilitate ease of use, the treatment was delivered via the Internet (Internet CBT; iCBT. Eleven participants with at least mild symptoms of depression (Patient Health Questionnaire 9-item (PHQ-9 total scores  > 4  or anxiety (Generalised Anxiety Disorder 7-item (GAD-7 total scores > 4  accessed the online Arab Wellbeing Course, which consisted of five online lessons delivered over 8 weeks. Measures of depression, anxiety, distress and disability were gathered at pre-treatment, post-treatment and 3-month follow-up. Data were analysed using mixed-linear model analyses. Ninety-one percent (10/11 of participants completed the five lessons over 8 weeks, with 10/11 providing post-treatment and 3-month follow-up data. Participants improved significantly across all outcome measures, with large within-group effect sizes based on estimated marginal means (Cohen's d at post-treatment (d = 1.08 to 1.74 and 3-month follow-up (d = 1.53 to 2.00. The therapist spent an average of 90.72 min (SD = 28.98 in contact, in total, with participants during the trial. Participants rated the Arab Wellbeing Course as acceptable. Caution is needed in interpreting the results of the current study given the small sample size employed, raising questions about the impact of levels of acculturation and the absence of a control group. However, the results are encouraging and indicate that, with minor modifications, western psychological interventions have the potential to be of benefit to English speaking Arab immigrants.

  19. Potential of Snoezelen room multisensory stimulation to improve balance in individuals with dementia: a feasibility randomized controlled trial.

    Science.gov (United States)

    Klages, Kelsey; Zecevic, Aleksandra; Orange, Joseph B; Hobson, Sandra

    2011-07-01

    To investigate the influence of multisensory stimulations in a Snoezelen room on the balance of individuals with dementia. Randomized controlled trial. Canadian long-term care home. Twenty-four residents (average age 86 years), in a long-term care home diagnosed with dementia, were assigned randomly to intervention and control groups. Nineteen participants completed the study. Nine intervention group participants completed 30-minute Snoezelen room sessions twice a week for six weeks. Sessions were guided by participants' preferences for stimulation. Interactions with tactile, visual and proprioceptive sensations were encouraged. Ten control group participants received an equal amount of volunteer visits. The Functional Reach Test, the eyes-open Sharpened Romberg and the Timed Up and Go Test with and without dual task, assessed static and dynamic balance at baseline and after the intervention. Falls frequencies were recorded six weeks before, during and after intervention. A journal was kept of observations in Snoezelen room. Split-plot MANOVA analyses revealed no significant effects of unstructured Snoezelen room sessions on participants' balance. There were no multivariate effects of time (F(4,14) = 1.13, P = 0.38) or group (F(4,14) = 0.63, P = 0.65). Group membership did not alter falls frequency. However, observations of participants' interactions with elements of the Snoezelen room, such as imagery-induced head and eye movements, vibrating sensations and kicking activities, captured events that can be used to create specific multisensory balance-enhancing stimulations. Although the null hypothesis was not rejected, further investigation of a potential to influence balance in individuals with dementia through Snoezelen room intervention in long-term care homes is warranted.

  20. Efficacy of meaning-centered group psychotherapy for cancer survivors : a randomized controlled trial

    NARCIS (Netherlands)

    van der Spek, N; Vos, J; van Uden-Kraan, C F; Breitbart, W.; Cuijpers, P; Holtmaat, K; Witte, B I; Tollenaar, R.A.E.M.; Verdonck-de Leeuw, I M

    BACKGROUND: The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). METHOD: A total of 170 cancer survivors were randomly assigned

  1. Comparing counselling alone versus counselling supplemented with guided use of a well-being app for university students experiencing anxiety or depression (CASELOAD): protocol for a feasibility trial.

    Science.gov (United States)

    Broglia, Emma; Millings, Abigail; Barkham, Michael

    2017-01-01

    University counselling services face a unique challenge to offer short-term therapeutic support to students presenting with complex mental health needs and in a setting which suits the academic timetable. The recent availability of mobile phone applications (apps) offers an opportunity to supplement face-to-face therapy and has the potential to reach a wider audience, maintain engagement between therapy sessions, and enhance therapeutic outcomes. The present study, entitled Counselling plus Apps for Students Experiencing Levels of Anxiety or Depression (CASELOAD), aims to explore the feasibility of supplementing counselling with guided use of a well-being app. Forty help-seeking university students (aged 18 years and over) with symptoms of moderate anxiety or depression will be recruited from a University Counselling Service (UCS) in the United Kingdom (UK). Participants will be recruited via counsellors who provide the initial clinical assessment and who determine treatment allocation to one of two treatments on the basis of client-treatment fit. The two conditions comprise (1) counselling alone (treatment as usual/TAU) or (2) counselling supplemented with guided use of a well-being app (enhanced intervention). Trained counsellors will deliver up to six counselling sessions in each treatment arm across a 6-month period, and the session frequency will be decided by client-counsellor discussion. Assessments will occur at baseline, every counselling session, post-intervention (3 months after consent) and follow-up (6 months after consent). Assessments will include clinical measures of anxiety, depression, psychological functioning, specific mental health concerns (e.g. academic distress and substance misuse), resilience and therapeutic alliance. The usage, acceptability, feasibility and potential implications of combining counselling with guided use of the well-being app will be assessed through audio recordings of counselling sessions, telephone interviews with

  2. The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas

    Science.gov (United States)

    Craig, Leone; Maclennan, Graeme; Boyers, Dwayne; Vale, Luke

    2012-01-01

    Objective To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge. Design Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation. Setting A postnatal ward in Scotland. Sample Women living in disadvantaged areas initiating breast feeding. Methods Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up. Main outcome measures Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding. Results There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation. Conclusions Proactive telephone care delivered by a dedicated feeding team shows

  3. Feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons in the Vascular Physician Offer and Report (VAPOR) Trial.

    Science.gov (United States)

    Goodney, Philip P; Spangler, Emily L; Newhall, Karina; Brooke, Benjamin S; Schanzer, Andres; Tan, Tze-Woei; Beck, Adam W; Hallett, John H; MacKenzie, Todd A; Edelen, Maria O; Hoel, Andrew W; Rigotti, Nancy A; Farber, Alik

    2017-04-01

    This study determined the feasibility and potential efficacy of an evidence-based standardized smoking cessation intervention delivered by vascular surgeons to smokers with peripheral arterial disease. We performed a cluster-randomized trial of current adult smokers referred to eight vascular surgery practices from September 1, 2014, to July 31, 2015. A three-component smoking cessation intervention (physician advice, nicotine replacement therapy, and telephone-based quitline referral) was compared with usual care. The primary outcome was smoking cessation for 7 days, assessed 3 months after the intervention. Secondary outcomes were patients' nicotine dependence and health expectancies of smoking assessed using Patient Reported Outcomes Measurement Information System (PROMIS; RAND Corporation, Santa Monica, Calif). We enrolled 156 patients (65 in four intervention practices, 91 in four control practices), and 141 (90.3%) completed follow-up. Patients in the intervention and control practices were similar in age (mean, 61 years), sex (68% male), cigarettes per day (mean, 14), and prior quit attempts (77%). All three components of the intervention were delivered to 75% of patients in intervention practices vs to 7% of patients at control practices (P intervention group quit smoking (23 of 56 patients quit who completed follow-up, plus 1 death included in the analysis in the denominator as a smoker), and 26 of 84 patients (30.9%) In the control group quit smoking (26 patients of 84 who completed follow-up, including 2 deaths included in the denominator as smokers). This difference (40.3% quit rate in intervention, 31% quit rate in control; P = .250) was not statistically significant in crude analyses (P = .250) or analyses adjusted for clustering (P = .470). Multivariable analysis showed factors associated with smoking cessation were receipt of physician advice (odds ratio for cessation, 1.96; 95% confidence interval, 1.28-3.02; P smoking cessation

  4. Accuracy, reliability, feasibility and nurse acceptance of a subcutaneous continuous glucose management system in critically ill patients: a prospective clinical trial.

    Science.gov (United States)

    Wollersheim, Tobias; Engelhardt, Lilian Jo; Pachulla, Jeanne; Moergeli, Rudolf; Koch, Susanne; Spies, Claudia; Hiesmayr, Michael; Weber-Carstens, Steffen

    2016-12-01

    subcutaneous CGM system did not perform with satisfactory accuracy, feasibility, or nursing acceptance when evaluated in 20 medical-surgical ICU patients. Low point accuracy and prolonged data gaps significantly limited the potential clinical usefulness of the CGM trend data. Accurate continuous data display, with a MARD < 14 %, showed potential benefits in a subgroup of our patients. Trial registration NCT02296372; Ethic vote Charité EA2/095/14.

  5. A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors.

    Science.gov (United States)

    Donnelly, C M; Blaney, J M; Lowe-Strong, A; Rankin, J P; Campbell, A; McCrum-Gardner, E; Gracey, J H

    2011-09-01

    To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments. A two arm, single blind, randomised controlled trial was conducted within the Northern Ireland regional Cancer Centre. Thirty three sedentary gynaecological cancer survivors (stage I-III; ≤3 years post diagnosis), experiencing cancer-related fatigue (mild-severe) took part. Participants were randomly assigned to a behavioural change, moderate intensity physical activity intervention (n=16) or a Contact Control group (n=17). The primary outcome was fatigue (Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale). Secondary outcomes included quality of life, physical functioning, positive and negative affect, depression, body composition, sleep dysfunction and self-reported physical activity. Feasibility was assessed based on the recruitment rate, programme and physical activity adherence and participants' programme evaluation, including optional focus groups (n=16). Twenty five percent of eligible women took part (33/134). Participants were 8.7 (SD=9.1) months post diagnosis, with a mean age of 53 (SD=10.3) years. The majority of the sample had a diagnosis of ovarian (n=12) or endometrial cancer (n=11). Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up (12 week: mean difference=-11.06; 95% confidence interval (CI)=-21.89 to -0.23; effect size (d)=0.13; p=0.046; 6 month: mean difference=-19.48; 95% CI=-19.67 to -19.15; effect size (d)=0.20; p=0.01). A mean of 10 calls (SD=1.2 calls) were delivered to the Physical Activity Group, and 10 (SD=1.6 calls) to the CC group. The intervention was positively perceived based on exit questionnaire and focus group findings. A physical activity behavioural change intervention for

  6. CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer.

    Science.gov (United States)

    Tsianakas, Vicki; Harris, Jenny; Ream, Emma; Van Hemelrijck, Mieke; Purushotham, Arnie; Mucci, Lorelei; Green, James S A; Fewster, Jacquetta; Armes, Jo

    2017-02-15

    Walking is an adaptable, inexpensive and accessible form of physical activity. However, its impact on quality of life (QoL) and symptom severity in people with advanced cancer is unknown. This study aimed to assess the feasibility and acceptability of a randomised controlled trial (RCT) of a community-based walking intervention to enhance QoL in people with recurrent/metastatic cancer. We used a mixed-methods design comprising a 2-centre RCT and nested qualitative interviews. Patients with advanced breast, prostate, gynaecological or haematological cancers randomised 1:1 between intervention and usual care. The intervention comprised Macmillan's 'Move More' information, a short motivational interview with a recommendation to walk for at least 30 min on alternate days and attend a volunteer-led group walk weekly. We assessed feasibility and acceptability of the intervention and RCT by evaluating study processes (rates of recruitment, consent, retention, adherence and adverse events), and using end-of-study questionnaires and qualitative interviews. Patient-reported outcome measures (PROMs) assessing QoL, activity, fatigue, mood and self-efficacy were completed at baseline and 6, 12 and 24 weeks. We recruited 42 (38%) eligible participants. Recruitment was lower than anticipated (goal n=60), the most commonly reported reason being unable to commit to walking groups (n=19). Randomisation procedures worked well with groups evenly matched for age, sex and activity. By week 24, there was a 45% attrition rate. Most PROMs while acceptable were not sensitive to change and did not capture key benefits. The intervention was acceptable, well tolerated and the study design was judged acceptable and feasible. Results are encouraging and demonstrate that exercise was popular and conveyed benefit to participants. Consequently, an effectiveness RCT is warranted, with some modifications to the intervention to include greater tailoring and more appropriate PROMs selected. ISRCTN

  7. Update to a protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Kadir, Bryar; Garfield, Kirsty; Lyons, Ronan A; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence, and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. In addition, this paper describes an update that has been made to the protocol for the PLAN-A feasibility cluster randomised controlled trial. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer supporters. Approximately 15% of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be

  8. The Effect of Family-Centered Empowerment Program on Self-Efficacy of Adolescents with Thalassemia Major: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Leili Borimnejad

    2018-01-01

    Full Text Available Background: Chronic nature of thalassemia causes changes in different aspects of life in patients, including their self-efficacy. The aim of this study was to determine the effect of family-centered empowerment program on the self-efficacy of adolescents with Thalassemia major. Methods: A quasi-experimental study was performed on adolescents with thalassemia major in 2013 in Bandar Abbas, Iran. The participants were divided into intervention and control groups, respectively. Research instruments included demographic data questionnaire, need assessment self-made questionnaire, general self-efficacy scale, and sickle cell self-efficacy scale. After collecting the data from the pre-intervention step, family-centered empowerment program was implemented for the intervention group and secondary test was conducted six weeks after the intervention and the results were analyzed by statistical SPSS-21 software, using independent t-test, paired t-test, Chi-square and Fisher’s exact test, and descriptive statistics. A significance level of P<0.05 was considered as significant. Results: The mean and standard deviation of the adolescents’ age were 16±1.9 in the intervention group and 15.2±2 in the control group. Independent t-test showed a significant difference between the two groups after the intervention for both self-efficacies (P<0.01 and P=0.02. In the control group, the results of general self-efficacy scores after six weeks’ time were reduced compared to the previous one while disease-related self-efficacy scores in the same group after six weeks’ time increased and paired t-test indicated a significant difference in the mean scores for both self-efficacies in both groups. Conclusion: Implementation of family-centered empowerment program for patients with thalassemia major is practically feasible and it can increase self-efficacy in these patients. It is suggested that the program should be used in comprehensive care protocols of children

  9. Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design.

    Science.gov (United States)

    Atkinson, Nancy L; Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi

    2011-01-01

    Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations. Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order. The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better. Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions. By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.

  10. A feasible method to improve adherence of Hawley retainer in adolescent orthodontic patients: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lin FO

    2015-10-01

    Full Text Available Feiou Lin,1 Hao Sun,1 Zhenyu Ni,1 Minling Zheng,1 Linjie Yao2 1Orthodontic Department, 2Pedodontic Department, School of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China Background: Retention is an important component of orthodontic treatment; however, poor compliance with retainer use is often encountered, especially in adolescents. The purpose of this study was to prove the hypothesis that verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Methods: This study was a randomized controlled trial. The sample was recruited from Wenzhou, People’s Republic of China, between February 2013 and May 2014, and 326 participants were randomized into three groups. Patients and parents in Group A (n=106 were given routine retainer wear instructions only; in Group B (n=111, images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients, combined with routine instructions; and in Group C (n=109, images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients and parents, combined with routine instructions. Three months after debonding, questionnaires were used to investigate daily wear time and the reasons for poor compliance. Differences in means between the groups were tested by one-way analysis of variance. Results: The mean daily wear time in Group C (15.09±4.13 hours was significantly greater than in Group A (12.37±4.58 hours, P<0.01 or Group B (13.50±4.22 hours, P<0.05; the mean daily wear time in Group B was greater than in Group A, but was not significant (P=0.67. Reasons for nonusage were forgetting to wear the retainer (51% and finding the retainer bothersome to frequently insert and remove (42%. Conclusion: Verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Parents play an

  11. Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zhang

    Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

  12. Electronic data capture and DICOM data management in multi-center clinical trials

    Science.gov (United States)

    Haak, Daniel; Page, Charles-E.; Deserno, Thomas M.

    2016-03-01

    Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging has become increasingly important in clinical trials. Here, subject's data is today captured in electronic case reports forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject's medical image data into eCRFs is insufficiently supported. Neither integration of subject's digital imaging and communications in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible. This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel, where subject's image data is stored and retrieved. Background communication with the PACS is completely hidden for the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are reduced, while, a research database is implicitly built up in the background.

  13. Acceptability and proof of concept of internet-delivered treatment for depression, anxiety, and stress in university students: protocol for an open feasibility trial.

    Science.gov (United States)

    Frazier, Patricia; Richards, Derek; Mooney, Jacqueline; Hofmann, Stefan G; Beidel, Deborah; Palmieri, Patrick A; Bonner, Christopher

    2016-01-01

    In recent years, university counseling and mental health services have reported an increase in the number of clients seeking services and in yearly visits. This trend has been observed at many universities, indicating that behavioral and mental health issues pose significant problems for many college students. The aim of this study is to assess the acceptability and proof of concept of internet-delivered treatment for depression, anxiety, and stress for university students. The study is an open feasibility trial of the SilverCloud programs for depression (Space from Depression), anxiety (Space from Anxiety), and stress (Space from Stress). All three are 8-module internet-delivered CBT (iCBT) intervention programs. Participants are assigned a supporter who provides weekly feedback on progress and exercises. Participants will complete the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and stress subscale of the Depression, Anxiety, Stress Scale-21 (DASS-21) as the outcome measures for the depression, anxiety, and stress interventions, respectively. Other outcomes include measures of acceptability of, and satisfaction, with the intervention. Data will be collected at baseline, 8 weeks and 3-month follow-up. It is anticipated that the study will inform the researchers and service personnel of the programs' potential to reduce depression, anxiety, and stress in a student population as well as the protocols to be employed in a future trial. In addition, it will provide insight into students' engagement with the programs, their user experience, and their satisfaction with the online delivery format.

  14. Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil; Arostegui, Jorge; Nava-Aguilera, Elizabeth; Harris, Eva; Ledogar, Robert J

    2017-05-30

    Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate), in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. The Camino Verde (Green Way) is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137-140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3-9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples) and entomological indices between intervention and control sites. Our hypothesis is that informed community mobilisation adds effectiveness in controlling

  15. Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study.

    Science.gov (United States)

    Touillaud, M; Foucaut, A-M; Berthouze, S E; Reynes, E; Kempf-Lépine, A-S; Carretier, J; Pérol, D; Guillemaut, S; Chabaud, S; Bourne-Branchu, V; Perrier, L; Trédan, O; Fervers, B; Bachmann, P

    2013-10-28

    After a diagnosis of localised breast cancer, overweight, obesity and weight gain are negatively associated with prognosis. In contrast, maintaining an optimal weight through a balanced diet combined with regular physical activity appears to be effective protective behaviour against comorbidity or mortality after a breast cancer diagnosis. The primary aim of the Programme pour une Alimentation Saine et une Activité Physique Adaptée pour les patientes atteintes d'un cancer du Sein (PASAPAS) randomised controlled trial is to evaluate the feasibility of implementing an intervention of adapted physical activity (APA) for 6 months concomitant with the prescription of a first line of adjuvant chemotherapy. Secondary aims include assessing the acceptability of the intervention, compliance to the programme, process implementation, patients' satisfaction, evolution of biological parameters and the medicoeconomic impact of the intervention. The study population consists of 60 women eligible for adjuvant chemotherapy after a diagnosis of localised invasive breast cancer. They will be recruited during a 2-year inclusion period and randomly allocated between an APA intervention arm and a control arm following a 2:1 ratio. All participants should benefit from personalised dietetic counselling and patients allocated to the intervention arm will be offered an APA programme of two to three weekly sessions of Nordic walking and aerobic fitness. During the 6-month intervention and 6-month follow-up, four assessments will be performed including blood draw, anthropometrics and body composition measurements, and questionnaires about physical activity level, diet, lifestyle factors, psychological criteria, satisfaction with the intervention and medical data. The study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud-Est IV) and the national agencies for biomedical studies and for privacy. All participants will give written informed consent. The study

  16. Biomarker-driven trial in metastatic pancreas cancer: feasibility in a multicenter study of saracatinib, an oral Src inhibitor, in previously treated pancreatic cancer.

    Science.gov (United States)

    Arcaroli, John; Quackenbush, Kevin; Dasari, Arvind; Powell, Rebecca; McManus, Martine; Tan, Aik-Choon; Foster, Nathan R; Picus, Joel; Wright, John; Nallapareddy, Sujatha; Erlichman, Charles; Hidalgo, Manuel; Messersmith, Wells A

    2012-10-01

    Src tyrosine kinases are overexpressed in pancreatic cancers, and the oral Src inhibitor saracatinib has shown antitumor activity in preclinical models of pancreas cancer. We performed a CTEP-sponsored Phase II clinical trial of saracatinib in previously treated pancreas cancer patients, with a primary endpoint of 6-month survival. A Simon MinMax two-stage phase II design was used. Saracatinib (175 mg/day) was administered orally continuously in 28-day cycles. In the unselected portion of the study, 18 patients were evaluable. Only two (11%) patients survived for at least 6 months, and three 6-month survivors were required to move to second stage of study as originally designed. The study was amended as a biomarker-driven trial (leucine rich repeat containing protein 19 [LRRC19] > insulin-like growth factor-binding protein 2 [IGFBP2] "top scoring pairs" polymerase chain reaction [PCR] assay, and PIK3CA mutant) based on preclinical data in a human pancreas tumor explant model. In the biomarker study, archival tumor tissue or fresh tumor biopsies were tested. Biomarker-positive patients were eligible for the study. Only one patient was PIK3CA mutant in a 3' untranslated region (UTR) portion of the gene. This patient was enrolled in the study and failed to meet the 6-month survival endpoint. As the frequency of biomarker-positive patients was very low (pancreatic cancer patients treated with a Src inhibitor based on a biomarker would improve 6-month survival, we demonstrate that testing pancreatic tumor samples for a biomarker-driven, multicenter study in metastatic pancreas cancer is feasible.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  18. Using data from the Microsoft Kinect 2 to determine postural stability in healthy subjects: A feasibility trial.

    Directory of Open Access Journals (Sweden)

    Behdad Dehbandi

    Full Text Available The objective of this study was to determine whether kinematic data collected by the Microsoft Kinect 2 (MK2 could be used to quantify postural stability in healthy subjects. Twelve subjects were recruited for the project, and were instructed to perform a sequence of simple postural stability tasks. The movement sequence was performed as subjects were seated on top of a force platform, and the MK2 was positioned in front of them. This sequence of tasks was performed by each subject under three different postural conditions: "both feet on the ground" (1, "One foot off the ground" (2, and "both feet off the ground" (3. We compared force platform and MK2 data to quantify the degree to which the MK2 was returning reliable data across subjects. We then applied a novel machine-learning paradigm to the MK2 data in order to determine the extent to which data from the MK2 could be used to reliably classify different postural conditions. Our initial comparison of force plate and MK2 data showed a strong agreement between the two devices, with strong Pearson correlations between the trunk centroids "Spine_Mid" (0.85 ± 0.06, "Neck" (0.86 ± 0.07 and "Head" (0.87 ± 0.07, and the center of pressure centroid inferred by the force platform. Mean accuracy for the machine learning classifier from MK2 was 97.0%, with a specific classification accuracy breakdown of 90.9%, 100%, and 100% for conditions 1 through 3, respectively. Mean accuracy for the machine learning classifier derived from the force platform data was lower at 84.4%. We conclude that data from the MK2 has sufficient information content to allow us to classify sequences of tasks being performed under different levels of postural stability. Future studies will focus on validating this protocol on large populations of individuals with actual balance impairments in order to create a toolkit that is clinically validated and available to the medical community.

  19. Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Parekh, Niyati; Jiang, Jieying; Buchan, Marissa; Meyers, Marleen; Gibbs, Heather; Krebs, Paul

    2017-06-17

    Knowledge of nutrition among breast cancer patients is insufficient, despite their motivation to seek valid information about healthy food choices. This study examines the feasibility of nutrition education workshops for cancer survivors, to inform the design of a multi-center intervention. Fifty-nine female English-speaking breast cancer patients, who had completed treatment, were enrolled. Participants were randomized to the intervention or control group. The intervention group attended six nutrition education sessions, and the control group received brochures. Measurements were done at baseline and 3-month follow-up and included the Assessment Instrument for Breast Cancer (NLit-BCa), fruit/vegetable and general health literacy screeners. Height and weight were measured. Changes in nutrition literacy, health literacy, and food intake from baseline to follow-up (within-group change) were calculated for both groups (effect sizes were reported as Cohen's d). Participants were mostly white, with a mean age of 58 years, BMI of 31.6 kg/m2, and had college degrees. Follow-up rates were high (89% = control and 77% = intervention group). At baseline, participants scored high for most NLit-BCa assessment components except food portions in both groups. At the 3-month follow-up, effect sizes (d) on the NLit-BCa ranged from -0.5 to 0.16. The study met its recruitment goals within 6 months. Focus groups indicated that (a) attending six sessions was acceptable, (b) patients found social/emotional support, (c) improvements should include information for special diets and booster sessions. This pilot study suggests that the intervention was acceptable and that scaling up of this intervention is feasible and could provide benefit to breast cancer survivors.

  20. ClinicalTrials.gov reporting: strategies for success at an academic health center.

    Science.gov (United States)

    O'Reilly, Erin K; Hassell, Nancy J; Snyder, Denise C; Natoli, Susan; Liu, Irwin; Rimmler, Jackie; Amspacher, Valerie; Burnett, Bruce K; Parrish, Amanda B; Berglund, Jelena P; Stacy, Mark

    2015-02-01

    The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training, and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.

  1. A prospective feasibility trial of a novel intravascular catheter system with retractable coiled tip guidewire placed in difficult intravascular access (DIVA) patients in the Emergency Department.

    Science.gov (United States)

    Raio, Christopher; Elspermann, Robert; Kittisarapong, Natwalee; Stankard, Brendon; Bajaj, Tanya; Modayil, Veena; Nelson, Mathew; Chiricolo, Gerardo; Wie, Benjamin; Snock, Alexandra; Mackay, Michael; Ash, Adam

    2017-09-14

    The primary study objective was to evaluate insertion success rates. Secondary objectives included patient satisfaction, procedure time, complication rates, completion of therapy and dwell time of the novel AccuCath(®) 2.25″ Blood Control (BC) Catheter System (FDA approved) placed in difficult-access patients. This was a single-arm feasibility trial evaluating the AccuCath(®) 2.25″ BC Catheter System in a convenience sample of DIVA patients defined as at least two failed initial attempts or a history of difficult access plus the inability to directly visualize or palpate a target vein. All enrolled patients were 18 years of age or older. A total of 120 patients were enrolled. These patients had an average of 3.7 and median of 3 prior attempts at vascular access prior to AccuCath placement. Successful access was gained in 100% of the patients, 77% on the first attempt and all within three attempts; 88.5% of patients completed therapy, with the remaining 12.5% experiencing minor complications that required discontinuation of the catheter. The average patient satisfaction score on a 5-point Likert scale was highly positive at 4.6. Preliminary results show that the AccuCath(®) 2.25″ BC Catheter System has excellent success rates in gaining vascular access in an extremely difficult patient population. The device did not lead to any significant complications. Patients were also very satisfied with the procedure.

  2. The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania

    Directory of Open Access Journals (Sweden)

    Lees Shelley

    2007-07-01

    Full Text Available Abstract Background During a microbicide trial feasibility study among women at high-risk of HIV and sexually transmitted infections in Mwanza, northern Tanzania we used participatory research tools to facilitate open dialogue and partnership between researchers and study participants. Methods A community-based sexual and reproductive health service was established in ten city wards. Wards were divided into seventy-eight geographical clusters, representatives at cluster and ward level elected and a city-level Community Advisory Committee (CAC with representatives from each ward established. Workshops and community meetings at ward and city-level were conducted to explore project-related concerns using tools adapted from participatory learning and action techniques such as listing, scoring, ranking, chapatti diagrams and pair-wise matrices. Results Key issues identified included beliefs that blood specimens were being sold for witchcraft purposes; worries about specula not being clean; inadequacy of transport allowances; and delays in reporting laboratory test results to participants. To date, the project has responded by inviting members of the CAC to visit the laboratory to observe how blood and genital specimens are prepared; demonstrated the use of the autoclave to community representatives; raised reimbursement levels; introduced HIV rapid testing in the clinic; and streamlined laboratory reporting procedures. Conclusion Participatory techniques were instrumental in promoting meaningful dialogue between the research team, study participants and community representatives in Mwanza, allowing researchers and community representatives to gain a shared understanding of project-related priority areas for intervention.

  3. Feasibility and efficacy of the Great Leaders Active StudentS (GLASS) program on children's physical activity and object control skill competency: A non-randomised trial.

    Science.gov (United States)

    Nathan, Nicole; Sutherland, Rachel; Beauchamp, Mark R; Cohen, Kristen; Hulteen, Ryan M; Babic, Mark; Wolfenden, Luke; Lubans, David R

    2017-04-21

    This study aimed to assess the feasibility and efficacy of the Great Leaders Active StudentS (GLASS) program, a school-based peer-led physical activity and object control skill intervention. The study employed a quasi-experimental design. The study was conducted in two elementary schools, one intervention and one comparison, in Newcastle, New South Wales (NSW), Australia from April to June 2015 (N=224 students). Peer leaders (n=20) in the intervention school received training to deliver two 30-min object control skill sessions per week to students in Kindergarten, Grades 1 and 2 (5-8 years, n=83) over one school term (10 weeks). The primary outcome was pedometer assessed physical activity during school hours. Secondary outcomes included students' object control skill competency and peers' leadership self-efficacy and teacher ratings of peers' leadership skills. Almost all (19/20) GLASS sessions were delivered by peer leaders who reported high acceptability of the program. The treatment-by-time interaction for students' physical activity during school hours was not significant (p=0.313). The intervention effect on students' overall object control skills was statistically significant (mean difference 5.8 (95% CI 4.1, 7.4; pskills as well as teacher-rated peers' leadership behaviours. Future fully powered trials using peer leaders to deliver fundamental movement skill (FMS) programs are warranted. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  4. Which Factors Are Important for Successful Sentinel Node Navigation Surgery in Gastric Cancer Patients? Analysis from the SENORITA Prospective Multicenter Feasibility Quality Control Trial

    Directory of Open Access Journals (Sweden)

    Ji Yeong An

    2017-01-01

    Full Text Available Background. We investigated the results of quality control study prior to phase III trial of sentinel lymph node navigation surgery (SNNS. Methods. Data were reviewed from 108 patients enrolled in the feasibility study of laparoscopic sentinel basin dissection (SBD in gastric cancer. Seven steps contain tracer injection at submucosa (step 1 and at four sites (step 2 by intraoperative esophagogastroduodenoscopy (EGD, leakage of tracer (step 3, injection within 3 minutes (step 4, identification of at least one sentinel basin (SB (step 5, evaluation of sentinel basin nodes (SBNs by frozen biopsy (step 6, and identification of at least five SBNs at back table and frozen sections (step 7. Results. Failure in step 7 (n=23 was the most common followed by step 3 (n=15 and step 6 (n=13. We did not find any differences of clinicopathological factors between success and failure group in steps 1~6. In step 7, body mass index (BMI was only the significant factor. The success rate was 97.1% in patients with BMI  <  23 kg/m2 and 80.3% in those with BMI ≥ 23 kg/m2 (P=0.028. Conclusions. Lower BMI group showed higher success rate in step 7. Surgeons doing SNNS should be cautious when evaluating sufficient number of SBN in obese patients.

  5. Modafinil in the treatment of crack-cocaine dependence in the Netherlands: Results of an open-label randomised controlled feasibility trial.

    Science.gov (United States)

    Nuijten, Mascha; Blanken, Peter; van den Brink, Wim; Hendriks, Vincent

    2015-06-01

    Crack-cocaine dependence is a serious disorder with no approved pharmacological treatment. Modafinil is a promising medication with increased cocaine abstinence and reduced craving in some previous studies. In the present study, we examined the acceptance, safety and potential benefits of modafinil as an add-on treatment to cognitive behavioural therapy (CBT) in crack-cocaine dependent patients. Sixty-five crack-cocaine dependent outpatients participated in an open-label, randomised feasibility trial. Patients were randomised to receive either 12-week individual CBT plus 400 mg/day modafinil or 12-week individual CBT only. The primary outcome measure was CBT treatment retention. Secondary outcomes included modafinil adherence, tolerability and safety, use of cocaine and other substances, cocaine craving, health, social functioning and patient satisfaction. Modafinil adherence was low, with only 10% treatment completers. Intent-to-treat analyses showed that modafinil did not improve CBT treatment retention or any of the secondary cocaine-related outcomes. Both groups showed similar, large reductions in cocaine use during the study treatment. Post hoc exploratory analyses within the CBT plus modafinil group showed significantly larger baseline to week 12 reductions in cocaine use days in high (⩾ 8 weeks) modafinil adherent patients. Acceptance and benefits of modafinil were not demonstrated in the present study. Since reduction in cocaine use was observed in high modafinil adherent patients, further research in the treatment of cocaine dependence, in which modafinil adherence is optimised, is warranted. © The Author(s) 2015.

  6. TIGA-CUB - manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5-11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Edginton, Elizabeth; Walwyn, Rebecca; Burton, Kayleigh; Cicero, Robert; Graham, Liz; Reed, Sadie; Tubeuf, Sandy; Twiddy, Maureen; Wright-Hughes, Alex; Ellis, Lynda; Evans, Dot; Hughes, Tom; Midgley, Nick; Wallis, Paul; Cottrell, David

    2017-09-15

    The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial. TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3

  7. Increasing children's physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial.

    Science.gov (United States)

    Jago, Russell; Sebire, Simon J; Davies, Ben; Wood, Lesley; Banfield, Kathryn; Edwards, Mark J; Powell, Jane E; Montgomery, Alan A; Thompson, Janice L; Fox, Kenneth R

    2015-02-18

    Many children do not engage in recommended levels of physical activity (PA), highlighting the need to find ways to increase children's PA. Process evaluations play an important role in improving the science of randomised controlled trials. We recently reported the results of the Action 3:30 cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls. The aim of this paper is to report the process evaluation results including intervention fidelity, implementation, context and how intervention components and trial design could be improved before proceeding to a definitive RCT. Children's session enjoyment was assessed every two weeks. Reasons for non-attendance were provided by questionnaire at the end of the intervention. Post intervention interviews were held with participating teaching assistants (TAs) and school key contacts (KCs), and focus groups were conducted with children in all 10 intervention schools. Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received. Data indicated good intervention fidelity with TA's adopting enjoyment-focussed teaching styles and the sessions improving children's skills and self-esteem. Several positive aspects of implementation were identified, including high session variety, the opportunity to work in teams, the child-led sessions and the engaging leader style. In terms of context there was evidence that TA's faced difficulties managing challenging behaviour and that further training in this area was needed. TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment. The programme could be improved to enhance interest for girls, by including training for managing disruptive behaviour and making some activities more age

  8. Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Blackshaw, Helen; Carding, Paul; Jepson, Marcus; Mat Baki, Marina; Ambler, Gareth; Schilder, Anne; Morris, Stephen; Degun, Aneeka; Yu, Rosamund; Husbands, Samantha; Knowles, Helen; Walton, Chloe; Karagama, Yakubu; Heathcote, Kate; Birchall, Martin

    2017-09-29

    A functioning voice is essential for normal human communication. A good voice requires two moving vocal folds; if one fold is paralysed (unilateral vocal fold paralysis (UVFP)) people suffer from a breathy, weak voice that tires easily and is unable to function normally. UVFP can also result in choking and breathlessness. Current treatment for adults with UVFP is speech therapy to stimulate recovery of vocal fold (VF) motion or function and/or injection of the paralysed VF with a material to move it into a more favourable position for the functioning VF to close against. When these therapies are unsuccessful, or only provide temporary relief, surgery is offered. Two available surgical techniques are: (1) surgical medialisation; placing an implant near the paralysed VF to move it to the middle (thyroplasty) and/or repositioning the cartilage (arytenoid adduction) or (2) restoring the nerve supply to the VF (laryngeal reinnervation). Currently there is limited evidence to determine which surgery should be offered to adults with UVFP. A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life. Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial. ISRCTN90201732; 16 December 2015. © Article

  9. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  10. A Protocol for a Feasibility and Acceptability Study of a Participatory, Multi-Level, Dynamic Intervention in Urban Outreach Centers to Improve the Oral Health of Low-Income Chinese Americans

    Directory of Open Access Journals (Sweden)

    Mary E. Northridge

    2018-02-01

    Full Text Available IntroductionWhile the US health care system has the capability to provide amazing treatment of a wide array of conditions, this care is not uniformly available to all population groups. Oral health care is one of the dimensions of the US health care delivery system in which striking disparities exist. More than half of the population does not visit a dentist each year. Improving access to oral health care is a critical and necessary first step to improving oral health outcomes and reducing disparities. Fluoride has contributed profoundly to the improved dental health of populations worldwide and is needed regularly throughout the life course to protect teeth against dental caries. To ensure additional gains in oral health, fluoride toothpaste should be used routinely at all ages. Evidence-based guidelines for annual dental visits and brushing teeth with fluoride toothpaste form the basis of this implementation science project that is intended to bridge the care gap for underserved Asian American populations by improving access to quality oral health care and enhancing effective oral health promotion strategies. The ultimate goal of this study is to provide information for the design and implementation of a randomized controlled trial of a participatory, multi-level, partnered (i.e., with community stakeholders intervention to improve the oral and general health of low-income Chinese American adults.MethodsThis study will evaluate the feasibility and acceptability of implementing a partnered intervention using remote data entry into an electronic health record (EHR to improve access to oral health care and promote oral health. The research staff will survey a sample of Chinese American patients (planned n = 90 screened at three outreach centers about their satisfaction with the partnered intervention. Providers (dentists and community health workers, research staff, administrators, site directors, and community advisory board members will

  11. A prospective, multi-center clinical trial of the Taylor intragastric balloon for the treatment of morbid obesity.

    Science.gov (United States)

    Marshall, J B; Schreiber, H; Kolozsi, W; Vasudeva, R; Bacon, B R; McCullough, A J; Holt, S

    1990-07-01

    This report describes the result of a prospective, multicenter clinical trial of the Taylor intragastric balloon for the treatment of morbid obesity. Sixty patients, who had failed sustained weight loss on prior dietary restriction and behavior modification programs, were enrolled in four clinical centers. The Taylor intragastric balloon, a 550-ml, pear-shaped, liquid-filled, silicone device, was inserted in all patients for a period of 16 wk, and patients were maintained on a dietary restriction and behavior modification program. During the study period, patients experienced a 11.6% decrease in mean weight and an 11.4% decrease in body mass index. Seven balloons deflated spontaneously. Examination of these balloons revealed a manufacturing defect that was subsequently corrected. No further deflations occurred. Effects of the balloons on gastric mucosa were minimal with no gastric erosions or ulcerations noted.

  12. A multi-center, double blind clinical trial comparing benefit from three commonly used hearing aid circuits.

    Science.gov (United States)

    Larson, Vernon D; Williams, David W; Henderson, William G; Luethke, Lynn E; Beck, Lucille B; Noffsinger, Douglas; Bratt, Gene W; Dobie, Robert A; Fausti, Stephen A; Haskell, George B; Rappaport, Bruce Z; Shanks, Janet E; Wilson, Richard H

    2002-08-01

    Although numerous studies have demonstrated that hearing aids provide significant benefit, carefully controlled, multi-center clinical trials have not been conducted. A multi-center clinical trial was conducted to compare the efficacy of three commonly used hearing aid circuits: peak clipping, compression limiting, and wide dynamic range compression. Patients (N = 360) with bilateral, sensorineural hearing loss were studied using a double blind, three-period, three-treatment crossover design. The patients were fit with each of three programmable hearing aid circuits. Outcome tests were administered in the unaided condition at baseline and then after 3 mo usage of each circuit, the tests were administered in both aided and unaided conditions. The outcome test battery included tests of speech recognition, sound quality and subjective scales of hearing aid benefit, including patients' overall rank-order rating of the three circuits. Each hearing aid circuit improved speech recognition markedly, with greater improvement observed for soft and conversationally loud speech in both quiet and noisy listening conditions. In addition, a significant reduction in the problems encountered in communication was observed. Some tests suggested that the two compression hearing aids provided a better listening experience than the peak clipping hearing aid. In the rank-order ratings, patients preferred the compression limiting hearing aid more frequently than the other two hearing aids. The three hearing aid circuits studied provide significant benefit both in quiet and in noisy listening situations. The two compression hearing aids appear to provide superior benefits compared to the linear circuit, although the differences between the hearing aids were smaller than the differences between unaided and aided conditions.

  13. Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

    Science.gov (United States)

    Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

    2010-10-01

    Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

  14. Alcohol screening and brief intervention in a college student health center: a randomized controlled trial.

    Science.gov (United States)

    Schaus, James F; Sole, Mary Lou; McCoy, Thomas P; Mullett, Natalie; O'Brien, Mary Claire

    2009-07-01

    This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students who screened positive for high-risk drinking. Between November 2005 and August 2006, 8,753 students who presented as new patients to the health service at a large public university were screened for high-risk drinking, and 2,484 students (28%) screened positive on the 5/4 gender-specific high-risk drinking question (i.e., five or more drinks per occasion for men and four or more for women). Students who screened positive for high-risk drinking and consented to participate (N= 363; 52% female) were randomly assigned either to a control group (n = 182) or to an experimental group (n = 181). Participants in the experimental group received two brief intervention sessions that were founded in motivational interviewing techniques and delivered by four specially trained providers within the student health center. Data on alcohol use and related harms were obtained from a Web-based Healthy Lifestyle Questionnaire, 30-day Timeline Followback alcohol-use diaries, the Rutgers Alcohol Problem Index (RAPI), and eight items from the Drinker Inventory of Consequences-2L. Repeated measures analysis showed that, compared with the control group (C), the intervention group (I) had significant reductions in typical estimated blood alcohol concentration (BAC) (C = .071 vs I = .057 at 3 months; C = .073 vs I = .057 at 6 months), peak BAC (C = . 142 vs I = .112 at 3 months; C = .145 vs I = .108 at 6 months), peak number of drinks per sitting (C = 8.03 vs I = 6.87 at 3 months; C = 7.98 vs I = 6.52 at 6 months), average number of drinks per week (C = 9.47 vs I = 7.33 at 3 months; C = 8.90 vs I = 6.16 at 6 months), number of drunk episodes in a typical week (C = 1.24 vs I = 0.85 at 3 months; C = 1.10 vs I = 0.71 at 6 months), number of times taken foolish risks (C = 2.24 vs I = 1.12 at 3 months), and RAPI sum scores (C = 6.55 vs I = 4

  15. Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: an NCI Treatment Referral Center Trial TRC-0301.

    Science.gov (United States)

    Chen, Helen X; Mooney, Margaret; Boron, Matthew; Vena, Don; Mosby, Kimberly; Grochow, Louise; Jaffe, Carl; Rubinstein, Lawrence; Zwiebel, James; Kaplan, Richard S

    2006-07-20

    To provide bevacizumab (BV) -based therapy to patients with advanced colorectal cancers (CRC) who had exhausted standard chemotherapy options, and to evaluate the response to BV combined with fluorouracil (FU) and leucovorin (LV) in this patient population. This was a multicenter, single-arm treatment trial conducted under the National Cancer Institute Treatment Referral Center network nationwide. Patients were treated with BV 5 mg/kg every 2 weeks combined with FU/LV; FU was administered by bolus or continuous infusion. Eligibility criteria included advanced CRC that had progressed after irinotecan- and oxaliplatin-based chemotherapy, Eastern Cooperative Oncology Group performance status 0 to 2, and absence of thromboembolism. The primary end point was objective response rate (RR) in the first 100 assessable patients. All patients received follow-up for toxicity and survival. Due to rapid accrual, a total of 350 patients were enrolled at 32 participating sites nationwide by October 2003. In the initially planned cohort of 100 assessable patients, the objective RR was 4% (95% CI, 1.1% to 9.9%) by investigators' assessment and 1% (95% CI, 0% to 5.5%) based on independent review; median progression-free survival was 3.5 months and median overall survival was 9.0 months. The safety profile was similar to prior BV trials in CRC. Grade 3 to 4 hemorrhage occurred in 5% of patients, including 3.8% with bleeding in the GI tract. Other adverse events such as hypertension, thrombosis, and bowel perforation were also observed at rates consistent with other studies. For patients with advanced CRC that had progressed after both irinotecan-based and oxaliplatin-based chemotherapy regimens, the combination of BV and FU/LV was associated with rare objective responses.

  16. A randomized control trial feasibility evaluation of an mHealth intervention for wheelchair skill training among middle-aged and older adults

    Science.gov (United States)

    Miller, William C.

    2017-01-01

    Background Providing mobility skills training to manual wheelchair (MWC) users can have a positive impact on community participation, confidence and quality of life. Often such training is restricted or not provided at all because of the expense of, and limited access to, occupational and physical therapists before and after discharge. This is particularly true among middle-aged and older adults, who often have limited access to rehabilitation services and require more time to learn motor skills. A monitored MWC skills training home program, delivered using a computer tablet (mHealth), was developed as an alternative approach to service delivery. The purpose of this study was to evaluate the feasibility of implementing this mHealth MWC skills training program among middle-aged and older adults. Methods A 2 × 2 factorial design randomized controlled trial (RCT) was used to compare the mHealth intervention and control groups, with additional wheeling time as a second factor. Community-dwelling MWC users aged 55 and older, who had used their MWC for less than two years and propelled with two hands, were recruited. Feasibility outcomes related to process, resources, management and treatment criteria were collected. Results Eighteen participants were recruited, with a retention rate of 94%. Mean (±SD) duration for the first and second in-person training sessions were 90.1 ± 20.5 and 62.1 ± 5.5 min, respectively. In the treatment group, 78% achieved the minimum amount of home training (i.e., 300 min) over four weeks and 56% achieved the preferred training threshold (i.e., 600 min). Trainers reported only seven minor protocol deviations. No tablets were lost or damaged and there was one incident of tablet malfunction. No injuries or adverse incidents were reported during data collection or training activities. Participants indicated 98% agreement on the post-treatment benefit questionnaire. Discussion Overall, the study protocol enabled implementation of the

  17. A randomized control trial feasibility evaluation of an mHealth intervention for wheelchair skill training among middle-aged and older adults

    Directory of Open Access Journals (Sweden)

    Edward M. Giesbrecht

    2017-10-01

    Full Text Available Background Providing mobility skills training to manual wheelchair (MWC users can have a positive impact on community participation, confidence and quality of life. Often such training is restricted or not provided at all because of the expense of, and limited access to, occupational and physical therapists before and after discharge. This is particularly true among middle-aged and older adults, who often have limited access to rehabilitation services and require more time to learn motor skills. A monitored MWC skills training home program, delivered using a computer tablet (mHealth, was developed as an alternative approach to service delivery. The purpose of this study was to evaluate the feasibility of implementing this mHealth MWC skills training program among middle-aged and older adults. Methods A 2 × 2 factorial design randomized controlled trial (RCT was used to compare the mHealth intervention and control groups, with additional wheeling time as a second factor. Community-dwelling MWC users aged 55 and older, who had used their MWC for less than two years and propelled with two hands, were recruited. Feasibility outcomes related to process, resources, management and treatment criteria were collected. Results Eighteen participants were recruited, with a retention rate of 94%. Mean (±SD duration for the first and second in-person training sessions were 90.1 ± 20.5 and 62.1 ± 5.5 min, respectively. In the treatment group, 78% achieved the minimum amount of home training (i.e., 300 min over four weeks and 56% achieved the preferred training threshold (i.e., 600 min. Trainers reported only seven minor protocol deviations. No tablets were lost or damaged and there was one incident of tablet malfunction. No injuries or adverse incidents were reported during data collection or training activities. Participants indicated 98% agreement on the post-treatment benefit questionnaire. Discussion Overall, the study protocol enabled implementation of