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Sample records for controlled trial design

  1. Design, analysis and presentation of factorial randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Little Paul

    2003-11-01

    Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. Discussion Using a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

  2. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  3. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  4. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  5. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

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    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  6. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  7. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

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    Day Richard O

    2010-07-01

    Full Text Available Abstract Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol, PRN paracetamol (plus placebo time-contingent paracetamol or a double placebo study arm. The primary outcome will be time (days to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291.

  8. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

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    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  9. Design of clinical trials involving multiple hypothesis tests with a common control.

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    Schou, I Manjula; Marschner, Ian C

    2017-07-01

    Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. A worksite prevention program for construction workers: Design of a randomized controlled trial

    NARCIS (Netherlands)

    Oude Hengel, K.M.; Joling, C.I.; Proper, K.I.; Blatter, B.M.; Bongers, P.M.

    2010-01-01

    Background. A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program

  11. Evaluation of biases present in the cohort multiple randomised controlled trial design : a simulation study

    NARCIS (Netherlands)

    Candlish, Jane; Pate, Alexander; Sperrin, Matthew; Staa, Tjeerd P van

    2017-01-01

    BACKGROUND: The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key

  12. Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

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    Bradt, Joke

    2012-01-01

    Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

  13. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G

    2012-01-01

    bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design...... characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes....

  14. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

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    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  15. Design of a multi-arm randomized clinical trial with no control arm.

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    Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

    2016-01-01

    Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

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

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    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

  17. (Costeffectiveness of life review for Older Adults: Design of a randomized controlled trial

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    Onrust Simone

    2008-06-01

    Full Text Available Abstract Background Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design This manuscript describes the design of a study evaluating 'Looking for Meaning', a newly developed prevention course for older adults with depressive symptoms, based on life-review. Both clinical and economic effectiveness are evaluated in a pragmatic randomized controlled trial. The control condition of this 12-session preventive intervention is a 20-minute video movie. The primary outcome is symptoms of depression at post-treatment and follow-up (6 months after post-treatment. Secondary outcomes are symptoms of anxiety, satisfaction with life, mastery, reminiscence styles, quality of life, and health care costs. An additional result of this study is the insight into the working elements of the course, provided by the qualitative study. The qualitative data, mainly based on 20 open-ended interviews with participants, are to be analyzed with an emphasis on newly emerging insight. Discussion This study will add to the existing scientific knowledge in several ways, especially by also including an economic evaluation and a qualitative study to gain insight into the working mechanisms of the course, both rather new in the field of life review. Positive results of this study will make an evidence-based intervention to improve public health among older people available. Trial registration Current Controlled Trials Ltd, ISRCTN66645855

  18. Tai Chi for treating knee osteoarthritis: Designing a long-term follow up randomized controlled trial

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    Rones Ramel

    2008-07-01

    Full Text Available Abstract Background Knee Osteoarthritis (KOA is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. Methods/Design Forty eligible patients, age > 55 yr, BMI ≤ 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi or attention control (wellness education and stretching. The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks. Discussion In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence

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

    Science.gov (United States)

    Campbell, M K; Entwistle, V A; Cuthbertson, B H; Skea, Z C; Sutherland, A G; McDonald, A M; Norrie, J D; Carlson, R V; Bridgman, S

    2011-02-21

    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. 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). 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. Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this

  20. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  1. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

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    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  2. Randomized controlled trials and neuro-oncology: should alternative designs be considered?

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    Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

    2015-09-01

    Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

  3. Manual and Electroacupuncture for Labour Pain: Study Design of a Longitudinal Randomized Controlled Trial

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    Linda Vixner

    2012-01-01

    Full Text Available Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

  4. An investigation of motor learning during side-step cutting, design of a randomised controlled trial

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    Lemmink Koen APM

    2010-10-01

    Full Text Available Abstract Background Of all athletic knee injuries an anterior cruciate ligament (ACL rupture results in the longest time loss from sport. Regardless of the therapy chosen, conservative or reconstructive, athletes are often forced to reduce their level of physical activity and their involvement in sport. Moreover, a recent review reported prevalences of osteoarthritis ranging from 0% to 13% for patients with isolated ACL-deficient (ACL-D knees and respectively 21% to 48% in patients with combined injuries. The need for ACL injury prevention is clear. The identification of risk factors and the development of prevention strategies may therefore have widespread health and economic implications. The focus of this investigation is to assess the role of implicit and explicit motor learning in optimising the performance of a side-step-cutting task. Methods/design A randomized controlled laboratory study will be conducted. Healthy basketball players, females and males, 18 years and older, with no previous lower extremity injuries, playing at the highest recreational level will be included. Subjects will receive a dynamic feedback intervention. Kinematic and kinetic data of the hip, knee and ankle and EMG activity of the quadriceps, hamstrings and gastrocnemius will be recorded. Discussion Female athletes have a significantly higher risk of sustaining an ACL injury than male athletes. Poor biomechanical and neuromuscular control of the lower limb is suggested to be a primary risk factor of an ACL injury mechanism in females. This randomized controlled trial has been designed to investigate whether individual feedback on task performance appears to be an effective intervention method. Results and principles found in this study will be applied to future ACL injury prevention programs, which should maybe more focus on individual injury predisposition. Trial registration Trial registration number NTR2250.

  5. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression.

    Science.gov (United States)

    Viksveen, Petter; Relton, Clare; Nicholl, Jon

    2017-07-06

    Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial-the Depression in South Yorkshire (DEPSY) trial-involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials. This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design. ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.

  6. The randomised controlled trial design: unrecognized opportunities for health sciences librarianship.

    Science.gov (United States)

    Eldredge, Jonathan D

    2003-06-01

    to describe the essential components of the Randomised Controlled Trial (RCT) and its major variations; to describe less conventional applications of the RCT design found in the health sciences literature with potential relevance to health sciences librarianship; to discuss the limited number of RCTs within health sciences librarianship. narrative review supported to a limited extent with PubMed and Library Literature database searches consistent with specific search parameters. In addition, more systematic methods, including handsearching of specific journals, to identify health sciences librarianship RCTs. While many RCTs within the health sciences follow more conventional patterns, some RCTs assume certain unique features. Selected examples illustrate the adaptations of this experimental design to answering questions of possible relevance to health sciences librarians. The author offers several strategies for controlling bias in library and informatics applications of the RCT and acknowledges the potential of the electronic era in providing many opportunities to utilize the blinding aspects of RCTs. RCTs within health sciences librarianship inhabit a limited number of subject domains such as education. This limited scope offers both advantages and disadvantages for making Evidence-Based Librarianship (EBL) a reality. The RCT design offers the potential to answer far more EBL questions than have been addressed by the design to date. Librarians need only extend their horizons through use of the versatile RCT design into new subject domains to facilitate making EBL a reality.

  7. Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

    Science.gov (United States)

    Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

    2007-01-01

    Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

  8. A worksite prevention program for construction workers: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Proper Karin I

    2010-06-01

    Full Text Available Abstract Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1 two individual training sessions of a physical therapist to lower the physical workload, (2 a Rest-Break tool to improve the balance between work and recovery, and (3 two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278

  9. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

    Directory of Open Access Journals (Sweden)

    Kevin Sweet

    2014-01-01

    Full Text Available We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF or hypertension (HTN, managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC. Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®. OSUWMC patient participants with chronic disease (CD receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1 change in risk perception; (2 knowledge retention; (3 perceived personal control; (4 health behavior change; and, for the active arm (5, overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

  10. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  11. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fischer Mary

    2010-03-01

    Full Text Available Abstract Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen, bone formation (osteocalcin, and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry. Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16 to explore the feasibility of modeling skeletal

  12. Elementary science teachers' integration of engineering design into science instruction: results from a randomised controlled trial

    Science.gov (United States)

    Maeng, Jennifer L.; Whitworth, Brooke A.; Gonczi, Amanda L.; Navy, Shannon L.; Wheeler, Lindsay B.

    2017-07-01

    This randomised controlled trial used a mixed-methods approach to investigate the frequency and how elementary teachers integrated engineering design (ED) principles into their science instruction following professional development (PD). The ED components of the PD were aligned with Cunningham and Carlsen's [(2014). Teaching engineering practices. Journal of Science Teacher Education, 25, 197-210] guidelines for ED PD and promoted inclusion of ED within science teaching. The treatment group included 219 teachers from 83 schools. Participants in the control group included 145 teachers from 60 schools in a mid-Atlantic state. Data sources, including lesson overviews and videotaped classroom observations, were analysed quantitatively to determine the frequency of ED integration and qualitatively to describe how teachers incorporated ED into instruction after attending the PD. Results indicated more participants who attended the PD (55%) incorporated ED into instruction compared with the control participants (24%), χ2(1, n = 401) = 33.225, p .05) through ED lessons. In ED lessons, students typically conducted research and created and tested initial designs. The results suggest the PD supported teachers in implementing ED into their science instruction and support the efficacy of using Cunningham and Carlsen's (2014) guidelines to inform ED PD design.

  13. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koolhaas Wendy

    2010-08-01

    Full Text Available Abstract Background To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. Methods/design The study is a cluster-randomized controlled trial design (randomized at the supervisor level, with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1 changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2 improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3 enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. Discussion The intervention 'Staying healthy at work' has the

  14. A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

    Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  15. Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study

    Directory of Open Access Journals (Sweden)

    Jane Candlish

    2017-01-01

    Full Text Available Abstract Background The cohort multiple randomised controlled trial (cmRCT design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key concern of the cmRCT design: refusal to treatment is only present in the intervention arm, and this may lead to bias and reduce statistical power. Methods We used simulation studies to assess the effect of this refusal, both random and related to event risk, on bias of the effect estimator and statistical power. A series of simulations were undertaken that represent a cmRCT trial with time-to-event endpoint. Intention-to-treat (ITT, per protocol (PP, and instrumental variable (IV analysis methods, two stage predictor substitution and two stage residual inclusion, were compared for various refusal scenarios. Results We found the IV methods provide a less biased estimator for the causal effect when refusal is present in the intervention arm, with the two stage residual inclusion method performing best with regards to minimum bias and sufficient power. We demonstrate that sample sizes should be adapted based on expected and actual refusal rates in order to be sufficiently powered for IV analysis. Conclusion We recommend running both an IV and ITT analyses in an individually randomised cmRCT as it is expected that the effect size of interest, or the effect we would observe in clinical practice, would lie somewhere between that estimated with ITT and IV analyses. The optimum (in terms of bias and power instrumental variable method was the two stage residual inclusion method. We recommend using adaptive power calculations, updating them as refusal rates are collected in the trial recruitment phase in order to be sufficiently powered for IV analysis.

  16. Preventing musculoskeletal injuries among recreational adult volleyball players: design of a randomised prospective controlled trial.

    Science.gov (United States)

    Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

    2017-08-02

    Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational volleyball players. This article describes the design of a study evaluating the effectiveness of the developed intervention on the one-season occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational adult volleyball players. A randomized prospective controlled trial with a follow-up period of one volleyball season will be conducted. Participants will be healthy recreational adult volleyball players (18 years of age or older) practicing volleyball (training and/or match) at least twice a week. The intervention ('VolleyVeilig') consists of a warm-up program based on more than 50 distinct exercises (with different variations and levels). The effect of the intervention programme on the occurrence of injuries will be compared to volleyball as usual. Outcome measures will be incidence of acute injury (expressed as number of injuries per 1000 h of play) and prevalence of overuse injuries (expressed as percentage). This study will be one of the first randomized prospective controlled trials evaluating the effectiveness of an intervention on the occurrence of both acute and overuse injuries among recreational adult volleyball players. Outcome of this study could possibly lead to the nationwide implementation of the intervention in all volleyball clubs in The Netherlands, ultimately resulting in less injuries. Dutch Trial Registration NTR6202 , registered February 1st 2017. Version 3, February 2017.

  17. Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hees Hiske L

    2010-09-01

    Full Text Available Abstract Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a randomized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression. This occupational intervention is based on an earlier intervention, which was designed and proven effective by our research group, and is the only intervention to date that specifically targets work outcome in depressed employees. Methods/Design In a two-arm randomized controlled trial, a total of 117 participants are randomized to either 'care as usual' or ' care as usual' with the addition of occupational therapy. Patients included in the study are employees who are absent from work due to depression for at least 25% of their contract hours, and who have a possibility of returning to their own or a new job. The occupational intervention consists of six individual sessions, eight group sessions and a work-place visit over a 16-week period. By increasing exposure to the working environment, and by stimulating communication between employer and employee, the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies. Assessments take place at baseline, and at 6, 12, and 18-month follow-ups. Primary outcome measure is work participation (hours of absenteeism and time until work resumption. Secondary outcome measures are work functioning, symptomatology, health-related quality of life, and neurocognitive functioning. In addition, cost-effectiveness is evaluated from a societal perspective. Finally, mechanisms of change (intermediate outcomes and potential patient-treatment matching variables are investigated. Discussion This study hopes to provide valuable knowledge

  18. A worksite prevention program for construction workers: design of a randomized controlled trial.

    Science.gov (United States)

    Oude Hengel, Karen M; Joling, Catelijne I; Proper, Karin I; Blatter, Birgitte M; Bongers, Paulien M

    2010-06-14

    A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. NTR1278.

  19. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pellegrini Christine A

    2012-11-01

    Full Text Available Abstract Background Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Methods/design Ninety-six obese adults (BMI 30–39.9 kg/m2 will be randomized to one of three treatment conditions: (1 standard behavioral weight loss (STND, (2 technology-supported behavioral weight loss (TECH; or (3 self-guided behavioral weight loss (SELF. All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD’s and will not receive coaching calls. During months 1–6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer. STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. Discussion ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. Trial registration NCT01051713

  20. Empowerment of personal injury victims through the internet: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Elbers Nieke A

    2011-02-01

    Full Text Available Abstract Background Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. Methods/design The study is a two armed, randomized controlled trial (RCT, in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1 an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2 an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old. The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization, at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention

  1. Green tea polyphenols and Tai Chi for bone health: Designing a placebo-controlled randomized trial

    Directory of Open Access Journals (Sweden)

    Chyu Ming-Chien

    2009-09-01

    model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons. Discussion We present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women. Trial registration ClinicalTrials.gov identifier: NCT00625391

  2. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

    Science.gov (United States)

    Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Empowerment of disability benefit claimants through an interactive website: design of a randomized controlled trial

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    Bruinvels David J

    2009-05-01

    Full Text Available Abstract Background Individuals claiming a disability benefit after long-term sickness absence, have to undergo medical disability assessments. These assessments, often carried out by specialized physicians, can be complicated by wrong expectations or defensive attitudes of disability benefit claimants. It is hypothesized that empowerment of these claimants will enhance the physician-patient relationship by shifting claimants from a passive role to a more active and constructive role during disability assessments. Furthermore, empowerment of claimants may lead to a more realistic expectation and acceptance of the assessment outcome among claimants and may lead to a more accurate assessment by the physician. Methods/Design In a two-armed randomized controlled trial (RCT, 230 claimants will be randomized to either the intervention or control group. For the intervention group, an interactive website was designed http://www.wiagesprek.nl using an Intervention Mapping procedure. This website was tested during a pilot study among 51 claimants. The final version of the website consists of five interactive modules, in which claimants will be prepared and empowered step-by-step, prior to their upcoming disability assessment. Other website components are a forum, a personal health record, a personal diary, and information on disability assessment procedures, return to work, and coping with disease and work disability. Subjects from the control group will be directed to a website with commonly available information only. Approximately two weeks prior to their disability assessment, disability claimants will be recruited through the Dutch Workers Insurance Authority (UWV. Outcomes will be assessed at five occasions: directly after recruitment (baseline, prior to disability assessment, directly after disability assessment as well as 6 and 16 weeks after the assessment. The study's primary outcome is empowerment, measured with the Vrijbaan questionnaire

  4. Computerized cognitive training to improve mood in senior living settings: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Smith M

    2018-04-01

    Full Text Available Marianne Smith,1 Michael P Jones,2 Megan M Dotson,1 Fredric D Wolinsky3 1College of Nursing, The University of Iowa, Iowa City, IA, USA; 2Department of Biostatistics, College of Public Health, The University of Iowa, Iowa City, IA, USA; 3Department of Health, Management and Policy, College of Public Health, the University of Iowa, Iowa City, IA, USA Purpose: This two-arm, randomized controlled trial was designed to evaluate a computerized cognitive speed of processing (SOP training known as Road Tour in the generally older group of adults residing in assisted living (AL and related senior housing. Study aims focused on depression-related outcomes that were observed in earlier SOP studies using Road Tour with younger, home-dwelling seniors. Study design and baseline outcomes are discussed. Participants and methods: A community-based design engaged AL and related senior living settings as partners in research. Selected staff served as on-site research assistants who were trained to recruit, consent, and train a target of 300 participants from AL and independent living (IL programs to use the intervention and attention control computerized training. Ten hours of initial computerized training was followed by two booster sessions at 5 and 11 months. Outcome measures included Useful Field of View, 9-item Patient Health Questionnaire, 12-item Centers for Epidemiological Studies Depression scale, 7-item Generalized Anxiety Disorders, Brief Pain Inventory, and SF-36 Health Survey. Assessments occurred before randomization (pretraining and posttraining, 26 and 52 weeks. Results: A total of 351 participants were randomized to the intervention (n = 173 and attention control (n = 178 groups. There were no significant differences between groups in demographic characteristics, with the exception of education and reported osteoporosis. There were no significant differences in study outcomes between groups at baseline. Participants in AL had significantly lower

  5. A systematic review of the use of an expertise-based randomised controlled trial design.

    Science.gov (United States)

    Cook, Jonathan A; Elders, Andrew; Boachie, Charles; Bassinga, Ted; Fraser, Cynthia; Altman, Doug G; Boutron, Isabelle; Ramsay, Craig R; MacLennan, Graeme S

    2015-05-30

    Under a conventional two-arm randomised trial design, participants are allocated to an intervention and participating health professionals are expected to deliver both interventions. However, health professionals often have differing levels of expertise in a skill-based interventions such as surgery or psychotherapy. An expertise-based approach to trial design, where health professionals only deliver an intervention in which they have expertise, has been proposed as an alternative. The aim of this project was to systematically review the use of an expertise-based trial design in the medical literature. We carried out a comprehensive search of nine databases--AMED, BIOSIS, CENTRAL, CINAHL, Cochrane Methodology Register, EMBASE, MEDLINE, Science Citation Index, and PsycINFO--from 1966 to 2012 and performed citation searches using the ISI Citation Indexes and Scopus. Studies that used an expertise-based trial design were included. Two review authors independently screened the titles and abstracts and assessed full-text reports. Data were extracted and summarised on the study characteristics, general and expertise-specific study methodology, and conduct. In total, 7476 titles and abstracts were identified, leading to 43 included studies (54 articles). The vast majority (88%) used a pure expertise-based design; three (7%) adopted a hybrid design, and two (5%) used a design that was unclear. Most studies compared substantially different interventions (79%). In many cases, key information relating to the expertise-based design was absent; only 12 (28%) reported criteria for delivering both interventions. Most studies recruited the target sample size or very close to it (median of 101, interquartile range of 94 to 118), although the target was reported for only 40% of studies. The proportion of participants who received the allocated intervention was high (92%, interquartile range of 82 to 99%). While use of an expertise-based trial design is growing, it remains uncommon

  6. Design and implementation of an empowerment model to prevent elder abuse: a randomized controlled trial.

    Science.gov (United States)

    Estebsari, Fatemeh; Dastoorpoor, Maryam; Mostafaei, Davoud; Khanjani, Narges; Khalifehkandi, Zahra Rahimi; Foroushani, Abbas Rahimi; Aghababaeian, Hamidreza; Taghdisi, Mohammad Hossein

    2018-01-01

    Older adults are more vulnerable to health risks than younger people and may get exposed to various dangers, including elder abuse. This study aimed to design and implement an empowerment educational intervention to prevent elder abuse. This parallel randomized controlled trial was conducted in 2014-2016 for 18 months on 464 older adults aged above 60 years who visited health houses of 22 municipalities in Tehran. Data were collected using standard questionnaires, including the Elder Abuse-Knowledge Questionnaire, Health-Promoting Behavior Questionnaire, Health-Promoting Lifestyle Profile II, Barriers to Healthy Lifestyle, Perceived Social Support, Perceived Self-Efficacy, Loneliness Scale, Geriatric Depression Scale, Multidimensional Health Locus of Control Scale, and the SCARED (stress, coping, argument, resources, events, and dependence) tool. The intervention was done in twenty 45- to 60-minute training sessions over 6 months. Data analysis were performed using χ 2 tests, multiple linear and logistic regression, and structural equation modeling (SEM). The frequency of knowledge of elder abuse, self-efficacy, social support and health promoting lifestyle before the intervention was similar in the two groups. However, the frequency of high knowledge of elder abuse (94.8% in the intervention group and 46.6% in the control group), high self-efficacy (82.8% and 7.8%, respectively), high social support (97.0% and 10.3%, respectively) and high health promoting lifestyle (97.0% and 10.3%, respectively) was significantly higher ( P elder abuse risk (28.0% and 49.6%, respectively) was significantly less in the intervention group after the intervention. SEM standardized beta (Sβ) showed that the intervention had the highest impact on increase social support (Sβ=0.80, β=48.64, SE=1.70, P elder abuse risk was indirect and significant (Sβ=-0.406, β=-0.340, SE=0.03, P elder abuse.

  7. Elementary Science Teachers' Integration of Engineering Design into Science Instruction: Results from a Randomised Controlled Trial

    Science.gov (United States)

    Maeng, Jennifer L.; Whitworth, Brooke A.; Gonczi, Amanda L.; Navy, Shannon L.; Wheeler, Lindsay B.

    2017-01-01

    This randomised controlled trial used a mixed-methods approach to investigate the frequency and how elementary teachers integrated engineering design (ED) principles into their science instruction following professional development (PD). The ED components of the PD were aligned with Cunningham and Carlsen's [(2014). "Teaching engineering…

  8. The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics.

    Science.gov (United States)

    Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

    2013-07-01

    The workplace can be an important setting for addressing obesity. An increasing number of employers offer weight management programs. Present the design, rationale and baseline characteristics of the Steps to Health study (STH), a randomized trial to evaluate the effectiveness of two preexisting employee weight management programs offered at Duke University and Medical Center. 550 obese (BMI ≥30) employee volunteers were randomized 1:1 to two programs. Baseline data, collected between January 2011 and July 2012, included height/weight, accelerometry, workplace injuries, health care utilization, and questionnaires querying socio-cognitive factors, perceptions of health climate, physical activity, and dietary intake. In secondary analyses participants in the two programs will also be compared to a non-randomized observational control group of obese employees. At baseline, the mean age was 45 years, 83% were female, 41% white, and 53% black. Mean BMI was 37.2. Participants consumed a mean of 2.37 servings of fruits and vegetables per day (in the past week), participated in 11.5 min of moderate-to-vigorous physical activity, and spent 620 min being sedentary. STH addresses the need for evaluation of worksite interventions to promote healthy weight. In addition to having direct positive effects on workers' health, worksite programs have the potential to increase productivity and reduce health care costs. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. Ankles back in randomized controlled trial (ABrCt: braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Verhagen Evert ALM

    2011-09-01

    Full Text Available Abstract Background Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. Methods/Design This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. Discussion The ABrCt is the first randomized controlled trial to directly compare the secondary preventive

  10. Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

    Science.gov (United States)

    Knowles, Simon R; Ski, Chantal F; Langham, Robyn; O'Flaherty, Emmet; Thompson, David R; Rossell, Susan L; Moore, Gaye; Hsueh, Ya-Seng Arthur; Castle, David J

    2016-09-09

    Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community

  11. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  12. Empowerment of disability benefit claimants through an interactive website: design of a randomized controlled trial.

    Science.gov (United States)

    Samoocha, David; Bruinvels, David J; Anema, Johannes R; Steenbeek, Romy; van der Beek, Allard J

    2009-05-10

    Individuals claiming a disability benefit after long-term sickness absence, have to undergo medical disability assessments. These assessments, often carried out by specialized physicians, can be complicated by wrong expectations or defensive attitudes of disability benefit claimants. It is hypothesized that empowerment of these claimants will enhance the physician-patient relationship by shifting claimants from a passive role to a more active and constructive role during disability assessments. Furthermore, empowerment of claimants may lead to a more realistic expectation and acceptance of the assessment outcome among claimants and may lead to a more accurate assessment by the physician. In a two-armed randomized controlled trial (RCT), 230 claimants will be randomized to either the intervention or control group. For the intervention group, an interactive website was designed http://www.wiagesprek.nl using an Intervention Mapping procedure. This website was tested during a pilot study among 51 claimants. The final version of the website consists of five interactive modules, in which claimants will be prepared and empowered step-by-step, prior to their upcoming disability assessment. Other website components are a forum, a personal health record, a personal diary, and information on disability assessment procedures, return to work, and coping with disease and work disability. Subjects from the control group will be directed to a website with commonly available information only. Approximately two weeks prior to their disability assessment, disability claimants will be recruited through the Dutch Workers Insurance Authority (UWV). Outcomes will be assessed at five occasions: directly after recruitment (baseline), prior to disability assessment, directly after disability assessment as well as 6 and 16 weeks after the assessment. The study's primary outcome is empowerment, measured with the Vrijbaan questionnaire. Secondary outcomes include claimants' satisfaction

  13. Angiotensin receptor blockade in acute stroke. The Scandinavian Candesartan Acute Stroke Trial: rationale, methods and design of a multicentre, randomised- and placebo-controlled clinical trial (NCT00120003)

    DEFF Research Database (Denmark)

    Sandset, Else Charlotte; Murray, Gordon; Boysen, Gudrun Margrethe

    2010-01-01

    AND DESIGN: The Scandinavian Candesartan Acute Stroke Trial is an international randomised, placebo-controlled, double-blind trial of candesartan in acute stroke. We plan to recruit 2500 patients presenting within 30 h of stroke (ischaemic or haemorrhagic) and with systolic blood pressure =140 mm......Hg. The recruited patients are randomly assigned to candesartan or placebo for 7-days (doses increasing from 4 to 16 mg once daily). Randomisation is performed centrally via a secure web interface. The follow-up period is 6-months. Patients are included from the following nine North-European countries: Norway...

  14. Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

    Science.gov (United States)

    Janssen, Kasper W; van Mechelen, Willem; Verhagen, Evert Alm

    2011-09-27

    Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training

  15. Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

    Science.gov (United States)

    Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-09-01

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-21

    In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

  17. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements.

    Science.gov (United States)

    Smith, David H; Neutel, Joel M; Lacourcière, Yves; Kempthorne-Rawson, Joan

    2003-07-01

    This meta-analysis aimed to determine whether ambulatory blood pressure monitoring (ABPM) results from double-blind, placebo-controlled (DBPC) and prospective, randomized, open-label, blinded-endpoint (PROBE) hypertension trials are statistically comparable. Two DBPC and three PROBE parallel-group studies were selected from an angiotensin II receptor blocker clinical programme. These were fixed-dose studies involving similar mild to moderate hypertensive patient populations. All used SpaceLabs 90207 ABPM devices, and each comprised a 4-week placebo period and a 4-8-week treatment period. Data from patients receiving telmisartan 80 mg were used to compare the results of DBPC (126 patients) and PROBE (734 patients) trials. The analysis had approximately 87% power to show equivalence between the two design types in terms of ruling out differences of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. Office blood pressure was also compared. The change from baseline in mean 24-h ambulatory SBP was -12.2 mmHg in DBPC trials and -12.3 mmHg in PROBE trials, a rounded difference of 0.2 mmHg [95% confidence interval (CI): -1.8, 2.1]. The change from baseline in mean 24-h ambulatory DBP was -7.7 mmHg in DBPC trials versus -7.9 mmHg in PROBE trials, a difference of 0.2 mmHg (95% CI: -1.1, 1.5). Ambulatory pulse pressure results were identical. Thus, changes in mean 24-h ambulatory blood pressure from the DBPC and PROBE trials in this meta-analysis are statistically equivalent in terms of ruling out a difference of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. This supports the validity of the PROBE design in assessing antihypertensive efficacy based on blinded ABPM measurements.

  18. Design and implementation of an empowerment model to prevent elder abuse: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Estebsari F

    2018-04-01

    Full Text Available Fatemeh Estebsari,1 Maryam Dastoorpoor,2 Davoud Mostafaei,3 Narges Khanjani,4 Zahra Rahimi Khalifehkandi,5 Abbas Rahimi Foroushani,6 Hamidreza Aghababaeian,7 Mohammad Hossein Taghdisi8 1Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, 2Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 3Department of Nursing Management, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, 4Neurology Research Center, Kerman University of Medical Sciences, Kerman, 5Department of Health Education and Health Promotion, School of Health, Iran University of Medical Sciences, Tehran, 6Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, 7Nursing and Emergency Department, Dezful University of Medical Sciences, Dezful, 8Department of Health Education and Health Promotion, School of Health, Iran University of Medical Sciences, Tehran, Iran Background: Older adults are more vulnerable to health risks than younger people and may get exposed to various dangers, including elder abuse. This study aimed to design and implement an empowerment educational intervention to prevent elder abuse.Methods: This parallel randomized controlled trial was conducted in 2014–2016 for 18 months on 464 older adults aged above 60 years who visited health houses of 22 municipalities in Tehran. Data were collected using standard questionnaires, including the Elder Abuse-Knowledge Questionnaire, Health-Promoting Behavior Questionnaire, Health-Promoting Lifestyle Profile II, Barriers to Healthy Lifestyle, Perceived Social Support, Perceived Self-Efficacy, Loneliness Scale, Geriatric Depression Scale, Multidimensional Health Locus of Control Scale, and the SCARED (stress, coping, argument, resources, events, and dependence tool. The intervention was done in

  19. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

    Science.gov (United States)

    Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

    2017-04-12

    Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

  20. Marketing depression care management to employers: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marshall Donna

    2010-03-01

    Full Text Available Abstract Background Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. Methods In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. Discussion By

  1. Empowerment of personal injury victims through the internet: design of a randomized controlled trial.

    Science.gov (United States)

    Elbers, Nieke A; Akkermans, Arno J; Cuijpers, Pim; Bruinvels, David J

    2011-02-02

    Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI) victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. The study is a two armed, randomized controlled trial (RCT), in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1) an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2) an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old.The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization), at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention-to-treat principle. This study evaluates the effectiveness of an

  2. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    International Nuclear Information System (INIS)

    Ogilvie, Gina S; Cook, Darrel A; Mei, Wendy; Stuart, Gavin CE; Franco, Eduardo L; Coldman, Andrew J; Niekerk, Dirk J van; Krajden, Mel; Martin, Ruth E; Ehlen, Thomas G; Ceballos, Kathy; Peacock, Stuart J; Smith, Laurie W; Kan, Lisa

    2010-01-01

    In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  3. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.

    Science.gov (United States)

    2013-11-01

    Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed 'disability-free life' including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above ('US minorities') and 70 years and above (non-'US minorities'). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14,383 participants have been recruited. Recruitment and study completion are anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia. © 2013. Published by Elsevier Inc. All rights reserved.

  4. A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions.

    Science.gov (United States)

    McNulty, Cliodna; Ricketts, Ellie J; Rugman, Claire; Hogan, Angela; Charlett, Andre; Campbell, Rona

    2015-11-17

    Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants' behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development. We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT. We reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty-Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that

  5. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peerbooms Joost C

    2010-04-01

    Full Text Available Abstract Background If conservative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the attachment of the fascia to the os calcis might induce a healing rate. Methods and design A randomized controlled multi centre trial will be performed. The study population consists of 120 patients of 18 years and older. Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4,8,12,26 weeks and 1 year after the procedure. The main outcome measures of this study are pain and function measured with questionnaires. Conclusion Recent literature show positive effects for the treatment of tendinosis with autologous platelet injections. The forthcoming trial will compare treatment for chronic plantar fasciitis with a steroid injection versus an autologous platelet injection. Our results will be published as soon as they become available. Trial Registration Trial registration number: http://www.clinicaltrials.gov NCT00758641.

  6. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  7. Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

    Science.gov (United States)

    Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

    2016-02-01

    Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

  8. Marketing depression care management to employers: design of a randomized controlled trial.

    Science.gov (United States)

    Rost, Kathryn M; Marshall, Donna

    2010-03-16

    Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. By addressing the 'value to whom?' question, the study advances

  9. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population

    Directory of Open Access Journals (Sweden)

    Gardini Andrea

    2007-11-01

    Full Text Available Abstract Background The hospital treatment of heart failure frequently does not follow published guidelines, potentially contributing to the high morbidity, mortality and economic cost of this disorder. Consequently the development of clinical pathways has the potential to reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of clinical pathways in hospital treatment of acute heart failure. The primary objective of the trial was to evaluate the effectiveness of the implementation of clinical pathways for hospital treatment of heart failure in Italian hospitals. Methods/design Two-arm, cluster-randomized trial. 14 community hospitals were randomized either to arm 1 (clinical pathway: appropriate use of practice guidelines and supplies of drugs and ancillary services, new organization and procedures, patient education, etc. or to arm 2 (no intervention, usual care. 424 patients sample (212 in each group, 80% of power at the 5% significance level (two-sided. The primary outcome measure is in-hospital mortality. We will also analyze the impact of the clinical pathways comparing the length and the appropriateness of the stay, the rate of unscheduled readmissions, the customers' satisfaction and the costs treating the patients with the pathways and with the current practice along all the observation period. The quality of the care will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and by measuring key quality indicators at discharge. Discussion This paper examines the design of the evaluation of a complex

  10. Effectiveness of classroom based crew resource management training in the intensive care unit: study design of a controlled trial

    Science.gov (United States)

    2011-01-01

    Background Crew resource management (CRM) has the potential to enhance patient safety in intensive care units (ICU) by improving the use of non-technical skills. However, CRM evaluation studies in health care are inconclusive with regard to the effect of this training on behaviour and organizational outcomes, due to weak study designs and the scarce use of direct observations. Therefore, the aim of this study is to determine the effectiveness and cost-effectiveness of CRM training on attitude, behaviour and organization after one year, using a multi-method approach and matched control units. The purpose of the present article is to describe the study protocol and the underlying choices of this evaluation study of CRM in the ICU in detail. Methods/Design Six ICUs participated in a paired controlled trial, with one pre-test and two post test measurements (respectively three months and one year after the training). Three ICUs were trained and compared to matched control ICUs. The 2-day classroom-based training was delivered to multidisciplinary groups. Typical CRM topics on the individual, team and organizational level were discussed, such as situational awareness, leadership and communication. All levels of Kirkpatrick's evaluation framework (reaction, learning, behaviour and organisation) were assessed using questionnaires, direct observations, interviews and routine ICU administration data. Discussion It is expected that the CRM training acts as a generic intervention that stimulates specific interventions. Besides effectiveness and cost-effectiveness, the assessment of the barriers and facilitators will provide insight in the implementation process of CRM. Trial registration Netherlands Trial Register (NTR): NTR1976 PMID:22073981

  11. Effectiveness of classroom based crew resource management training in the intensive care unit: study design of a controlled trial

    Directory of Open Access Journals (Sweden)

    Kemper Peter F

    2011-11-01

    Full Text Available Abstract Background Crew resource management (CRM has the potential to enhance patient safety in intensive care units (ICU by improving the use of non-technical skills. However, CRM evaluation studies in health care are inconclusive with regard to the effect of this training on behaviour and organizational outcomes, due to weak study designs and the scarce use of direct observations. Therefore, the aim of this study is to determine the effectiveness and cost-effectiveness of CRM training on attitude, behaviour and organization after one year, using a multi-method approach and matched control units. The purpose of the present article is to describe the study protocol and the underlying choices of this evaluation study of CRM in the ICU in detail. Methods/Design Six ICUs participated in a paired controlled trial, with one pre-test and two post test measurements (respectively three months and one year after the training. Three ICUs were trained and compared to matched control ICUs. The 2-day classroom-based training was delivered to multidisciplinary groups. Typical CRM topics on the individual, team and organizational level were discussed, such as situational awareness, leadership and communication. All levels of Kirkpatrick's evaluation framework (reaction, learning, behaviour and organisation were assessed using questionnaires, direct observations, interviews and routine ICU administration data. Discussion It is expected that the CRM training acts as a generic intervention that stimulates specific interventions. Besides effectiveness and cost-effectiveness, the assessment of the barriers and facilitators will provide insight in the implementation process of CRM. Trial registration Netherlands Trial Register (NTR: NTR1976

  12. The long-term effect of minimalist shoes on running performance and injury: design of a randomised controlled trial

    Science.gov (United States)

    Fuller, Joel T; Thewlis, Dominic; Tsiros, Margarita D; Brown, Nicholas A T; Buckley, Jonathan D

    2015-01-01

    Introduction The outcome of the effects of transitioning to minimalist running shoes is a topic of interest for runners and scientists. However, few studies have investigated the longer term effects of running in minimalist shoes. The purpose of this randomised controlled trial (RCT) is to investigate the effects of a 26 week transition to minimalist shoes on running performance and injury risk in trained runners unaccustomed to minimalist footwear. Methods and analysis A randomised parallel intervention design will be used. Seventy-six trained male runners will be recruited. To be eligible, runners must be aged 18–40 years, run with a habitual rearfoot footfall pattern, train with conventional shoes and have no prior experience with minimalist shoes. Runners will complete a standardised transition to either minimalist or control shoes and undergo assessments at baseline, 6 and 26 weeks. 5 km time-trial performance (5TT), running economy, running biomechanics, triceps surae muscle strength and lower limb bone mineral density will be assessed at each time point. Pain and injury will be recorded weekly. Training will be standardised during the first 6 weeks. Primary statistical analysis will compare 5TT between shoe groups at the 6-week time point and injury incidence across the entire 26-week study period. Ethics and dissemination This RCT has been approved by the Human Research Ethics Committee of the University of South Australia. Participants will be required to provide their written informed consent prior to participation in the study. Study findings will be disseminated in the form of journal publications and conference presentations after completion of planned data analysis. Trial registration number This RCT has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000642785). PMID:26297368

  13. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Krüger Matthias

    2011-02-01

    Full Text Available Abstract Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for

  14. Reduction of claustrophobia during magnetic resonance imaging: methods and design of the 'CLAUSTRO' randomized controlled trial

    International Nuclear Information System (INIS)

    Enders, Judith; Teichgräber, Ulf; Hamm, Bernd; Dewey, Marc; Zimmermann, Elke; Rief, Matthias; Martus, Peter; Klingebiel, Randolf; Asbach, Patrick; Klessen, Christian; Diederichs, Gerd; Bengner, Thomas

    2011-01-01

    Magnetic resonance (MR) imaging has been described as the most important medical innovation in the last 25 years. Over 80 million MR procedures are now performed each year and on average 2.3% (95% confidence interval: 2.0 to 2.5%) of all patients scheduled for MR imaging suffer from claustrophobia. Thus, prevention of MR imaging by claustrophobia is a common problem and approximately 2,000,000 MR procedures worldwide cannot be completed due to this situation. Patients with claustrophobic anxiety are more likely to be frightened and experience a feeling of confinement or being closed in during MR imaging. In these patients, conscious sedation and additional sequences (after sedation) may be necessary to complete the examinations. Further improvements in MR design appear to be essential to alleviate this situation and broaden the applicability of MR imaging. A more open scanner configuration might help reduce claustrophobic reactions while maintaining image quality and diagnostic accuracy. We propose to analyze the rate of claustrophobic reactions, clinical utility, image quality, patient acceptance, and cost-effectiveness of an open MR scanner in a randomized comparison with a recently designed short-bore but closed scanner with 97% noise reduction. The primary aim of this study is thus to determine whether an open MR scanner can reduce claustrophobic reactions, thereby enabling more examinations of claustrophobic patients without incurring the safety issues associated with conscious sedation. In this manuscript we detail the methods and design of the prospective 'CLAUSTRO' trial. This randomized controlled trial will be the first direct comparison of open vertical and closed short-bore MR systems in regards to claustrophobia and image quality as well as diagnostic utility. ClinicalTrials.gov: (http://www.clinicaltrials.gov/ct2/show/NCT00715806)

  15. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  16. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    Directory of Open Access Journals (Sweden)

    Waldén Markus

    2009-06-01

    Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to

  17. The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

    Science.gov (United States)

    van Engelenburg-van Lonkhuyzen, Marieke L; Bols, Esther M J; Benninga, Marc A; Verwijs, Wim A; Bluijssen, Netty M W L; de Bie, Rob A

    2013-08-02

    Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. This section discusses the relevance of publishing the study design and the development of

  18. Effect of running therapy on depression (EFFORT-D. Design of a randomised controlled trial in adult patients [ISRCTN 1894

    Directory of Open Access Journals (Sweden)

    Kruisdijk Frank R

    2012-01-01

    Full Text Available Abstract Background The societal and personal burden of depressive illness is considerable. Despite the developments in treatment strategies, the effectiveness of both medication and psychotherapy is not ideal. Physical activity, including exercise, is a relatively cheap and non-harmful lifestyle intervention which lacks the side-effects of medication and does not require the introspective ability necessary for most psychotherapies. Several cohort studies and randomised controlled trials (RCTs have been performed to establish the effect of physical activity on prevention and remission of depressive illness. However, recent meta-analysis's of all RCTs in this area showed conflicting results. The objective of the present article is to describe the design of a RCT examining the effect of exercise on depressive patients. Methods/Design The EFFect Of Running Therapy on Depression in adults (EFFORT-D is a RCT, studying the effectiveness of exercise therapy (running therapy (RT or Nordic walking (NW on depression in adults, in addition to usual care. The study population consists of patients with depressive disorder, Hamilton Rating Scale for Depression (HRSD ≥ 14, recruited from specialised mental health care. The experimental group receives the exercise intervention besides treatment as usual, the control group receives treatment as usual. The intervention program is a group-based, 1 h session, two times a week for 6 months and of increasing intensity. The control group only performs low intensive non-aerobic exercises. Measurements are performed at inclusion and at 3,6 and 12 months. Primary outcome measure is reduction in depressive symptoms measured by the HRSD. Cardio-respiratory fitness is measured using a sub maximal cycling test, biometric information is gathered and blood samples are collected for metabolic parameters. Also, co-morbidity with pain, anxiety and personality traits is studied, as well as quality of life and cost

  19. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study

    Directory of Open Access Journals (Sweden)

    Flik Carla E

    2011-12-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. Methods/Design The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65 with IBS (Rome-III criteria. Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo, with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. Discussion If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. Trial registration number ISRCTN: ISRCTN22888906

  20. The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

    Science.gov (United States)

    Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

    2016-07-01

    Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kristensen Peter L

    2011-10-01

    circumference (p = .17, physical fitness (p = .93, and physical activity (accelerometer (p = .09. The randomization and matched pair design produced equivalent groups according to central outcome measures and background variables. The SPACE for physical activity Study will provide new insights on the effectiveness of multicomponent interventions to improve adolescents' physical activity level. Trial registration Current Controlled Trials ISRCTN79122411

  2. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595].

    Science.gov (United States)

    Hägglund, Martin; Waldén, Markus; Atroshi, Isam

    2009-06-23

    Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL) injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT) to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. In this cluster randomized trial 516 teams (309 clusters) in eight regional football districts in Sweden with female players aged 13-17 years were randomized into an intervention group (260 teams) or a control group (256 teams). The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October) and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1) baseline player data form collected at the start of the trial, (2) computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3) injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion) and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks). Outcome measures are assessed after the end of the 2009 season. Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to be effective in reducing the incidence of knee

  3. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    Science.gov (United States)

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

  4. (Cost)effectiveness of life review for Older Adults: Design of a randomized controlled trial

    NARCIS (Netherlands)

    Pot, A.M.; Melenhorst, A.S.; Onrust, S.; Bohlmeijer, E.

    2008-01-01

    Background Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design This manuscript describes the design of a study

  5. (Cost)effectiveness of life review for Older Adults: Design of a randomized controlled trial

    NARCIS (Netherlands)

    Pot, A.M.; Melenhorst, A.S.; Onrust, S.; Bohlmeijer, E.

    2008-01-01

    Background. Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design. This manuscript describes the design of a

  6. (Cost)effectiveness of life review for older adults : design of a randomized controlled trial

    NARCIS (Netherlands)

    Pot, Anne Margriet; Melenhorst, Anne-Sophie; Onrust, Simone; Bohlmeijer, Ernst T.

    2008-01-01

    Background: Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design: This manuscript describes the design of a

  7. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    Directory of Open Access Journals (Sweden)

    Mona Have

    2016-04-01

    Full Text Available Abstract Background Integration of physical activity (PA into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. Methods The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools’ math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF questionnaire filled out by the parents, creativity (using the Torrance Tests of Creative Thinking, TTCT, aerobic fitness (by the Andersen intermittent shuttle-run test and body mass index. PA during math lessons and total PA (including time spent outside school were assessed using accelerometry. Math teachers used Short Message Service (SMS-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children’s PA behavior in leisure time. Discussion The results of this randomized controlled trial are expected to provide schools and policy-makers with

  8. A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB project

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    Merle Corinne SC

    2012-05-01

    Full Text Available Abstract Background There have been no major advances in tuberculosis (TB drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385. Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically

  9. Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

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    Grotenhuis J André

    2007-11-01

    Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

  10. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Mansikkamäki Kirsi

    2010-08-01

    Full Text Available Abstract Background Annual prevalence of gestational diabetes mellitus (GDM is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g, age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost

  11. Duodenum preserving pancreatectomy in chronic pancreatitis: Design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764

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    Reidel Margot A

    2006-05-01

    Full Text Available Abstract Background Chronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue. Beside obstructive jaundice and pseudocyst formation, about half of the patients need surgical intervention due to untreatable chronic pain during the course of the disease. In most of the patients with chronic pancreatitis, the head of the pancreas is the trigger of the chronic inflammatory process. Therefore, resection of pancreatic head tissue must be the central part of any surgical intervention. However, it is unclear to which extent the surgical procedure must be radical in order to obtain a favourable outcome for the patients. Design A single centre randomized controlled, superiority trial to compare two techniques of duodenum preserving pancreatic head resection. Sample size: 65 patients will be included and randomized intraoperatively. Eligibility criteria: All patients with chronic pancreatitis and indication for surgical resection and signed informed consent. Cumulative primary endpoint (hierarchical model: duration of surgical procedure, quality of life after one year, duration of intensive care unit stay, duration of hospital stay. Reference treatment: Resection of the pancreatic head with dissection of the pancreas from the portal vein and transsection of the gland (Beger procedure. Intervention: Partial Resection of the pancreatic head without transsection of the organ and visualization of the portal vein (Berne procedure. Duration: September 2003-October 2007. Organisation/responsibility The trial is conducted in compliance with the protocol and in accordance with the moral, ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and the Good Clinical Practice guideline (GCP. The Center for Clinical Studies of the Department of Surgery Heidelberg is responsible for planning, conducting and final

  12. Development and evaluation of an intervention aiming to reduce fatigue in airline pilots: design of a randomised controlled trial.

    Science.gov (United States)

    van Drongelen, Alwin; van der Beek, Allard J; Hlobil, Hynek; Smid, Tjabe; Boot, Cécile R L

    2013-08-26

    A considerable percentage of flight crew reports to be fatigued regularly. This is partly caused by irregular and long working hours and the crossing of time zones. It has been shown that persistent fatigue can lead to health problems, impaired performance during work, and a decreased work-private life balance. It is hypothesized that an intervention consisting of tailored advice regarding exposure to daylight, optimising sleep, physical activity, and nutrition will lead to a reduction of fatigue in airline pilots compared to a control group, which receives a minimal intervention with standard available information. The study population will consist of pilots of a large airline company. All pilots who posses a smartphone or tablet, and who are not on sick leave for more than four weeks at the moment of recruitment, will be eligible for participation.In a two-armed randomised controlled trial, participants will be allocated to an intervention group that will receive the tailored advice to optimise exposure to daylight, sleep, physical activity and nutrition, and a control group that will receive standard available information. The intervention will be applied using a smartphone application and a website, and will be tailored on flight- and participant-specific characteristics. The primary outcome of the study is perceived fatigue. Secondary outcomes are need for recovery, duration and quality of sleep, dietary and physical activity behaviours, work-private life balance, general health, and sickness absence. A process evaluation will be conducted as well. Outcomes will be measured at baseline and at three and six months after baseline. This paper describes the development of an intervention for airline pilots, consisting of tailored advice (on exposure to daylight and sleep-, physical activity, and nutrition) applied into a smartphone application. Further, the paper describes the design of the randomised controlled trial evaluating the effect of the intervention on

  13. Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

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    Spinhoven Philip

    2009-09-01

    Full Text Available Abstract Background Panic disorder (PD and generalized anxiety disorder (GAD are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual. Methods/design The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC or care as usual (CAU. In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1 guided self-help, 2 cognitive behavioral therapy and 3 antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI. Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. Discussion It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of

  14. Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial

    NARCIS (Netherlands)

    Hees, Hiske L.; Koeter, Maarten W. J.; de Vries, Gabe; Ooteman, Wendy; Schene, Aart H.

    2010-01-01

    ABSTRACT: BACKGROUND: Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a

  15. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN38327949

    Science.gov (United States)

    Besselink, Marc GH; van Santvoort, Hjalmar C; Nieuwenhuijs, Vincent B; Boermeester, Marja A; Bollen, Thomas L; Buskens, Erik; Dejong, Cornelis HC; van Eijck, Casper HJ; van Goor, Harry; Hofker, Sijbrand S; Lameris, Johan S; van Leeuwen, Maarten S; Ploeg, Rutger J; van Ramshorst, Bert; Schaapherder, Alexander FM; Cuesta, Miguel A; Consten, Esther CJ; Gouma, Dirk J; van der Harst, Erwin; Hesselink, Eric J; Houdijk, Lex PJ; Karsten, Tom M; van Laarhoven, Cees JHM; Pierie, Jean-Pierre EN; Rosman, Camiel; Bilgen, Ernst Jan Spillenaar; Timmer, Robin; van der Tweel, Ingeborg; de Wit, Ralph J; Witteman, Ben JM; Gooszen, Hein G

    2006-01-01

    Background The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. Methods/design 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis. PMID:16606471

  16. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial: design and rationale of a randomised controlled multicenter trial [ISRCTN13975868

    Directory of Open Access Journals (Sweden)

    Houdijk Lex PJ

    2006-04-01

    Full Text Available Abstract Background The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL. In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach was conceived to yield the evidence needed for a considered policy decision. Methods/design 88 patients with (suspected infected necrotizing pancreatitis will be randomly allocated to either group A minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD or group B maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected infected necrotizing pancreatitis.

  17. A hand hygiene intervention to decrease infections among children attending day care centers: design of a cluster randomized controlled trial.

    Science.gov (United States)

    Zomer, Tizza P; Erasmus, Vicki; Vlaar, Nico; van Beeck, Ed F; Tjon-A-Tsien, Aimée; Richardus, Jan Hendrik; Voeten, Hélène A C M

    2013-06-03

    Day care center attendance has been recognized as a risk factor for acquiring gastrointestinal and respiratory infections, which can be prevented with adequate hand hygiene (HH). Based on previous studies on environmental and sociocognitive determinants of caregivers' compliance with HH guidelines in day care centers (DCCs), an intervention has been developed aiming to improve caregivers' and children's HH compliance and decrease infections among children attending DCCs. The aim of this paper is to describe the design of a cluster randomized controlled trial to evaluate the effectiveness of this intervention. The intervention will be evaluated in a two-arm cluster randomized controlled trial among 71 DCCs in the Netherlands. In total, 36 DCCs will receive the intervention consisting of four components: 1) HH products (dispensers and refills for paper towels, soap, alcohol-based hand sanitizer, and hand cream); 2) training to educate about the Dutch national HH guidelines; 3) two team training sessions aimed at goal setting and formulating specific HH improvement activities; and 4) reminders and cues to action (posters/stickers). Intervention DCCs will be compared to 35 control DCCs continuing usual practice. The primary outcome measure will be observed HH compliance of caregivers and children, measured at baseline and one, three, and six months after start of the intervention. The secondary outcome measure will be the incidence of gastrointestinal and respiratory infections in 600 children attending DCCs, monitored over six months by parents using a calendar to mark the days their child has diarrhea and/or a cold. Multilevel logistic regression will be performed to assess the effect of the intervention on HH compliance. Multilevel poisson regression will be performed to assess the incidence of gastrointestinal and respiratory infections in children attending DCCs. This is one of the first DCC intervention studies to assess HH compliance of both caregivers and

  18. TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes

    Directory of Open Access Journals (Sweden)

    Tuzzi Cristina

    2010-04-01

    Full Text Available Abstract Background Obesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Methods/Design TECNOB (TEChnology for OBesity is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month, that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only will be evaluated in a randomized controlled trial (RCT with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered. Discussion The TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on

  19. Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children

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    McLaren Sue

    2010-11-01

    Full Text Available Abstract Background Children with poor motor ability have been found to engage less in physical activities than other children, and a lack of physical activity has been linked to problems such as obesity, lowered bone mineral density and cardiovascular risk factors. Furthermore, if children are confident with their fine and gross motor skills, they are more likely to engage in physical activities such as sports, crafts, dancing and other physical activity programs outside of the school curriculum which are important activities for psychosocial development. The primary objective of this project is to comprehensively evaluate a whole of class physical activity program called Animal Fun designed for Pre-Primary children. This program was designed to improve the child's movement skills, both fine and gross, and their perceptions of their movement ability, promote appropriate social skills and improve social-emotional development. Methods The proposed randomized and controlled trial uses a multivariate nested cohort design to examine the physical (motor coordination and psychosocial (self perceptions, anxiety, social competence outcomes of the program. The Animal Fun program is a teacher delivered universal program incorporating animal actions to facilitate motor skill and social skill acquisition and practice. Pre-intervention scores on motor and psychosocial variables for six control schools and six intervention schools will be compared with post-intervention scores (end of Pre-Primary year and scores taken 12 months later after the children's transition to primary school Year 1. 520 children aged 4.5 to 6 years will be recruited and it is anticipated that 360 children will be retained to the 1 year follow-up. There will be equal numbers of boys and girls. Discussion If this program is found to improve the child's motor and psychosocial skills, this will assist in the child's transition into the first year of school. As a result of these changes

  20. A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

    Science.gov (United States)

    Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

    2017-07-18

    The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

  1. Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Mars, Tom; Ellard, David R; Antrobus, James H L; Cairns, Melinda; Underwood, Martin; Haywood, Kirstie; Keohane, Susie; Sandhu, Harbinder; Griffiths, Frances

    2015-01-01

    Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. A consensus conference involving expert professionals and lay members. Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to

  2. Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

    Science.gov (United States)

    Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

    2018-01-01

    Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Using simulation to aid trial design: Ring-vaccination trials.

    Directory of Open Access Journals (Sweden)

    Matt David Thomas Hitchings

    2017-03-01

    Full Text Available The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination.We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design.Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring vaccination design and on the

  4. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

    International Nuclear Information System (INIS)

    Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

    2016-01-01

    Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

  5. Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design

    Directory of Open Access Journals (Sweden)

    Hinman Rana S

    2012-09-01

    Full Text Available Abstract Background Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain. Methods/Design Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group and received no acupuncture treatment. The other three were treatment groups: i laser acupuncture, ii sham laser or, iii needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS and self-reported physical function measured by the Western Ontario and McMaster (WOMAC Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale and physical function (NRS. Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12

  6. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement.

    Science.gov (United States)

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær; Thomsen Ernst, Martin; Fredens, Kjeld; Støckel, Jan Toftegaard; Wedderkopp, Niels; Domazet, Sidsel Louise; Gudex, Claire; Grøntved, Anders; Kristensen, Peter Lund

    2016-04-11

    Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time. The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom

  7. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; Voils, Corrine I; Maciejewski, Matthew L; Coffman, Cynthia J; Jeffreys, Amy S; Turner, Marsha J; Gaillard, Leslie A; Hinton, Teresa A; Strawbridge, Elizabeth; Zervakis, Jennifer; Barton, Anna Beth; Yancy, William S

    2017-07-01

    Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes. Copyright © 2017. Published by Elsevier Inc.

  8. [On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

    Science.gov (United States)

    Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

    2014-02-01

    To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

  9. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  10. ENHANCE: Design and rationale of a randomized controlled trial for promoting enduring happiness & well-being.

    Science.gov (United States)

    Kushlev, Kostadin; Heintzelman, Samantha J; Lutes, Lesley D; Wirtz, Derrick; Oishi, Shigehiro; Diener, Ed

    2017-01-01

    Individuals who are higher in subjective well-being not only feel happier, they are more likely have fulfilling relationships, increased work performance and income, better physical health, and longer lives. Over the past several decades, the science of subjective well-being has produced insights into these benefits of happiness, and-recognizing their importance-has begun to examine the factors that lead to greater well-being, from cultivating strong relationships to pursuing meaningful goals. However, studies to date have typically focused on improving subjective well-being by intervening with singular constructs, using primarily college student populations, and were short-term in nature. Moreover, little is understood about the impact of a well-being treatment delivered online vs. in-person. In the present article, we describe a comprehensive intervention program including 3-month initial treatment followed by a 3-month follow-up, ENHANCE: Enduring Happiness and Continued Self-Enhancement. One-hundred and sixty participants will be recruited from two different sites to participate in one of two versions of ENHANCE: in-person (n=30) vs. wait-list control (n=30); or online (n=50) vs. wait-list control (n=50). Assessments will be completed at baseline, three months and six months. Our primary outcome is change in subjective well-being across treatment (3months) and follow-up (6months). Secondary outcomes include self-report and objective measures of health, as well as a psychological mediators (e.g., psychological needs) and moderators (e.g., personality) of treatment outcomes. We hope to provide researchers, practitioners, and individuals with an evidence-based treatment to improve happiness and subjective well-being. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART).

    Science.gov (United States)

    Patrick, K; Marshall, S J; Davila, E P; Kolodziejczyk, J K; Fowler, J H; Calfas, K J; Huang, J S; Rock, C L; Griswold, W G; Gupta, A; Merchant, G; Norman, G J; Raab, F; Donohue, M C; Fogg, B J; Robinson, T N

    2014-01-01

    To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. A total of 404 overweight or obese college students from three Southern California universities (M(age) = 22( ± 4) years; M(BMI) = 29( ± 2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, text messaging, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, diet, physical activity, sedentary behavior, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Theory-driven, evidence-based strategies for physical activity, sedentary behavior, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

    Science.gov (United States)

    Flik, Carla E; van Rood, Yanda R; Laan, Wijnand; Smout, André Jpm; Weusten, Bas Lam; Whorwell, Peter J; de Wit, Niek J

    2011-12-20

    Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. ISRCTN: ISRCTN22888906.

  13. Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study

    Directory of Open Access Journals (Sweden)

    Tompkins Charlotte

    2010-12-01

    Full Text Available Abstract Background The purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data. Methods Qualitative study involving 69 women participating in 7 focus groups and 17 in-depth interviews. 15 women had a previous diagnosis of breast cancer and 54 did not. Results The women held strong views and had a good understanding of the rationale of the design of clinical trials. The women recognised that in a very large trial with long-term follow-up it was necessary to incorporate design features to make the trial feasible and efficient. Most strikingly, they supported the idea of opt-out consent and identifying women with breast cancer using routine datasets. Conclusions This model of user involvement engaged women well with the design challenges of the trial and led to improvements to the protocol. The study strengthens the case for user involvement, in particular through focus groups and in-depth interviews, in the design of trials.

  14. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  15. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  16. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

    Science.gov (United States)

    Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

    2016-06-25

    The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

  17. Deep brain stimulation targeting the fornix for mild Alzheimer dementia: design of the ADvance randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Holroyd KB

    2015-07-01

    stimulation (DBS of memory circuits may improve symptoms and possibly slow disease progression. The ADvance trial was designed to examine DBS of the fornix as a treatment for mild AD. Methods: ADvance is a randomized, double-blind, placebo-controlled, delayed-start, multicenter clinical trial conducted at six sites in the US and one site in Canada. Eighty-five subjects initially consented to be screened for the trial. Of these, 42 subjects who met inclusion and exclusion criteria were implanted with DBS leads anterior to the columns of the fornix bilaterally. They were randomized 1:1 to DBS “off” or DBS “on” groups for the initial 12 months of follow-up. After 1 year, all subjects will have their devices turned “on” for the remainder of the study. Postimplantation, subjects will return for 13 follow-up visits over 48 months for cognitive and psychiatric assessments, brain imaging (up to 12 months, and safety monitoring. The primary outcome measures include Alzheimer's Disease Assessment Scale – cognitive component (ADAS-cog-13, Clinical Dementia Rating sum of boxes (CDR-SB, and cerebral glucose metabolism measured with positron emission tomography. This report details the study methods, baseline subject characteristics of screened and implanted participants, and screen-to-baseline test–retest reliability of the cognitive outcomes. Results: Implanted subjects had a mean age of 68.2 years, were mostly male (55%, and had baseline mean ADAS-cog-13 and CDR-SB scores of 28.9 (SD, 5.2 and 3.9 (SD, 1.6, respectively. There were no significant differences between screened and implanted or nonimplanted subjects on most demographic or clinical assessments. Implanted subjects had significantly lower (better ADAS-cog-11 (17.5 vs 21.1 scores, but did not differ on CDR-SB. Scores on the major outcome measures for the trial were consistent at screening and baseline. Conclusion: ADvance was successful in enrolling a substantial group of patients for this novel application of

  18. Designing and evaluating the effectiveness of a serious game for safe administration of blood transfusion: A randomized controlled trial.

    Science.gov (United States)

    Tan, Apphia Jia Qi; Lee, Cindy Ching Siang; Lin, Patrick Yongxing; Cooper, Simon; Lau, Lydia Siew Tiang; Chua, Wei Ling; Liaw, Sok Ying

    2017-08-01

    Preparing nursing students for the knowledge and skills required for the administration and monitoring of blood components is crucial for entry into clinical practice. Serious games create opportunities to develop this competency, which can be used as a self-directed learning strategy to complement existing didactic learning and simulation-based strategies. To describe the development and evaluation of a serious game to improve nursing students' knowledge, confidence, and performance in blood transfusion. An experiential gaming model was applied to guide the design of the serious game environment. A clustered, randomized controlled trial was conducted with 103 second-year undergraduate nursing students who were randomized into control or experimental groups. After a baseline evaluation of the participants' knowledge and confidence on blood transfusion procedure, the experimental group undertook a blood transfusion serious game and completed a questionnaire to evaluate their learning experience. All participants' clinical performances were evaluated in a simulated environment. The post-test knowledge and confidence mean scores of the experimental group improved significantly (pgame intervention compared to pre-test mean scores and to post-test mean scores of the control group (pgame positively. The study provided evidence on the effectiveness of a serious game in improving the knowledge and confidence of nursing students on blood transfusion practice. The features of this serious game could be further developed to incorporate additional scenarios with repetitive exercises and feedback to enhance the impact on clinical performance. Given the flexibility, practicality, and scalability of such a game, they can serve as a promising approach to optimize learning when blended with high-fidelity simulation. Copyright © 2017. Published by Elsevier Ltd.

  19. Randomized controlled trial of a self-management intervention in persons with spinal cord injury : design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    NARCIS (Netherlands)

    Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty

  20. A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.

    Science.gov (United States)

    Yan, Lijing L; Chen, Shu; Zhou, Bo; Zhang, Jing; Xie, Bin; Luo, Rong; Wang, Ninghua; Lindley, Richard; Zhang, Yuhong; Zhao, Yi; Li, Xian; Liu, Xiao; Peoples, Nicholas; Bettger, Janet Prvu; Anderson, Craig; Lamb, Sarah E; Wu, Yangfeng; Shi, Jingpu

    2016-10-01

    Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care. © 2016 World Stroke Organization.

  1. Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wenborn Jennifer

    2011-09-01

    Full Text Available Abstract Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201

  2. Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Joanne Mouthaan

    2011-11-01

    Full Text Available Background: Injured trauma victims are at risk of developing Posttraumatic Stress Disorder (PTSD and other post-trauma psychopathology. So far, interventions using cognitive behavioral techniques (CBT have proven most efficacious in treating early PTSD in highly symptomatic individuals. No early intervention for the prevention of PTSD for all victims has yet proven effective. In the acute psychosocial care for trauma victims, there is a clear need for easily applicable, accessible, cost-efficient early interventions. Objective: To describe the design of a randomized controlled trial (RCT evaluating the effectiveness of a brief Internet-based early intervention that incorporates CBT techniques with the aim of reducing acute psychological distress and preventing long-term PTSD symptoms in injured trauma victims. Method: In a two armed RCT, 300 injured trauma victims from two Level-1 trauma centers in Amsterdam, the Netherlands, will be assigned to an intervention or a control group. Inclusion criteria are: being 18 years of age or older, having experienced a traumatic event according to the diagnostic criteria of the DSM-IV and understanding the Dutch language. The intervention group will be given access to the intervention's website (www.traumatips.nl, and are specifically requested to login within the first month postinjury. The primary clinical study outcome is PTSD symptom severity. Secondary outcomes include symptoms of depression and anxiety, quality of life, and social support. In addition, a cost-effectiveness analysis of the intervention will be performed. Data are collected at one week post-injury, prior to first login (baseline, and at 1, 3, 6 and 12 months. Analyses will be on an intention-to-treat basis. Discussion: The results will provide more insight into the effects of preventive interventions in general, and Internet-based early interventions specifically, on acute stress reactions and PTSD, in an injured population, during the

  3. Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Taskila Taina

    2010-07-01

    Full Text Available Abstract Background Compared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large. Therefore, return-to-work of cancer patients needs to be improved by way of an intervention. The objective is to describe the development and content of a work-directed intervention to enhance return-to-work in cancer patients and to explain the study design used for evaluating the effectiveness of the intervention. Development and content of the intervention The work-directed intervention has been developed based on a systematic literature review of work-directed interventions for cancer patients, factors reported by cancer survivors as helping or hindering their return-to-work, focus group and interview data for cancer patients, health care professionals, and supervisors, and vocational rehabilitation literature. The work-directed intervention consists of: 1 4 meetings with a nurse at the treating hospital department to start early vocational rehabilitation, 2 1 meeting with the participant, occupational physician, and supervisor to make a return-to-work plan, and 3 letters from the treating physician to the occupational physician to enhance communication. Study design to evaluate the intervention The treating physician or nurse recruits patients before the start of initial treatment. Patients are eligible when they have a primary diagnosis of cancer, will be treated with curative intent, are employed at the time of diagnosis, are on sick leave, and are between 18 and 60 years old. After the patients have given informed consent and have filled out a baseline questionnaire, they are randomised to either the control group or to the intervention group and receive either care as usual or the work-directed intervention, respectively. Primary outcomes are return-to-work and quality of life. The feasibility of the intervention and direct and indirect costs will be

  4. Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study.

    Science.gov (United States)

    Dodd, Lori E; Proschan, Michael A; Neuhaus, Jacqueline; Koopmeiners, Joseph S; Neaton, James; Beigel, John D; Barrett, Kevin; Lane, Henry Clifford; Davey, Richard T

    2016-06-15

    Unique challenges posed by emerging infectious diseases often expose inadequacies in the conventional phased investigational therapeutic development paradigm. The recent Ebola outbreak in West Africa presents a critical case-study highlighting barriers to faster development. During the outbreak, clinical trials were implemented with unprecedented speed. Yet, in most cases, this fast-tracked approach proved too slow for the rapidly evolving epidemic. Controversy abounded as to the most appropriate study designs to yield safety and efficacy data, potentially causing delays in pivotal studies. Preparation for research during future outbreaks may require acceptance of a paradigm that circumvents, accelerates, or reorders traditional phases, without losing sight of the traditional benchmarks by which drug candidates must be assessed for activity, safety and efficacy. We present the design of an adaptive, parent protocol, ongoing in West Africa until January 2016. The exigent circumstances of the outbreak and limited prior clinical experience with experimental treatments, led to more direct bridging from preclinical studies to human trials than the conventional paradigm would typically have sanctioned, and required considerable design flexibility. Preliminary evaluation of the "barely Bayesian" design was provided through computer simulation studies. The understanding and public discussion of the study design will help its future implementation. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  5. Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hongying Kuang

    2013-01-01

    Full Text Available Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS, but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC. We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A true acupuncture and CC, (B control acupuncture and CC, (C true acupuncture and placebo CC, and (D control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.

  6. Fixed structure feedforward controller design exploiting iterative trials: application to a wafer stage and a desktop printer

    NARCIS (Netherlands)

    Meulen, van der S.H.; Tousain, R.L.; Bosgra, O.H.

    2008-01-01

    In this paper, the feedforward controller design problem for high-precision electromechanical servo systems that execute finite time tasks is addressed. The presented procedure combines the selection of the fixed structure of the feedforward controller and the optimization of the controller

  7. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Heutink Annelies

    2008-11-01

    Full Text Available Abstract Background Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. Development and description of intervention A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1 Consequences of a chronic disease in the workplace, 2 Insight into feelings and thoughts about having a chronic disease, 3 Communication in daily work situations, 4 Facilities for disabled employees and work disability legislation, 5 How to stand up for oneself, 6 A plan to solve problems, 7 Follow-up. Methods Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8

  8. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    Science.gov (United States)

    Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

    2016-07-01

    Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. SARCOPENIA: DESIGNING PHASE IIB TRIALS

    Science.gov (United States)

    CHUMLEA, WM.C.; CESARI, M.; EVANS, W.J.; FERRUCCI, L.; FIELDING, R.A.; PAHOR, M.; STUDENSKI, S.; VELLAS, B.

    2012-01-01

    Sarcopenia is the age-related involuntary loss of skeletal muscle mass and functionality that can lead to the development of disability, frailty and increased health care costs. The development of interventions aimed at preventing and/or treating sarcopenia is complex, requiring the adoption of assumptions and standards that are not well established scientifically or clinically. A number of investigators and clinicians (both from academia and industry) met in Rome (Italy) in 2009 to develop a consensus definition of sarcopenia. Subsequently, in Albuquerque (New Mexico, USA) in 2010, the same group met again to consider the complex issues necessary for designing Phase II clinical trials for sarcopenia. Current clinical trial data indicate that fat-free mass (FFM) parameters are responsive to physical activity/nutritional treatment modalities over short time periods, but pharmacological trials of sarcopenia have yet to show significant efficacy. In order to conduct a clinical trial within a reasonable time frame, groups that model or display accelerated aging and loss of FFM are necessary. Few studies have used acceptable designs for testing treatment effects, sample sizes or primary outcomes that could provide interpretable findings or effects across studies. Dual energy x ray absorptiometry (DXA) is the measure of choice for assessing FFM, but sufficient time is needed for changes to be detected accurately and reliably. A tool set that would allow clinical, basic and epidemiological research on sarcopenia to advance rapidly toward diagnosis and treatment phases should be those reflecting function and strength. PMID:21623466

  10. Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial.

    Science.gov (United States)

    AbdElmagied, Ahmed M; Vaughan, Lisa E; Weaver, Amy L; Laughlin-Tommaso, Shannon K; Hesley, Gina K; Woodrum, David A; Jacoby, Vanessa L; Kohi, Maureen P; Price, Thomas M; Nieves, Angel; Miller, Michael J; Borah, Bijan J; Gorny, Krzysztof R; Leppert, Phyllis C; Lemens, Maureen A; Stewart, Elizabeth A

    2016-09-01

    Uterine fibroids are an important source of morbidity for reproductive-aged women. Despite an increasing number of alternatives, hysterectomies account for about 75% of all fibroid interventional treatments. Evidence is lacking to help women and their health care providers decide among alternatives to hysterectomy. Fibroid Interventions: Reducing Symptoms Today and Tomorrow (NCT00995878, clinicaltrials.gov) is a randomized controlled trial to compare the safety, efficacy, and economics of 2 minimally invasive alternatives to hysterectomy: uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery. Although randomized trials provide the highest level of evidence, they have been difficult to conduct in the United States for interventional fibroid treatments. Thus, contemporaneously recruiting women declining randomization may have value as an alternative strategy for comparative effectiveness research. We sought to compare baseline characteristics of randomized participants with nonrandomized participants meeting the same enrollment criteria and to determine whether combining the 2 cohorts in a comprehensive cohort design would be useful for analysis. Premenopausal women with symptomatic uterine fibroids seeking interventional therapy at 3 US academic medical centers were randomized (1:1) in 2 strata based on calculated uterine volume (<700 and ≥700 cc(3)) to undergo embolization or focused ultrasound surgery. Women who met the same inclusion criteria but declined randomization were offered enrollment in a parallel cohort. Both cohorts were followed up for a maximum of 36 months after treatment. The measures addressed in this report were baseline demographics, symptoms, fibroid and uterine characteristics, and scores on validated quality-of-life measures. Of 723 women screened, 57 were randomized and 49 underwent treatment (27 with focused ultrasound and 22 with embolization). Seven of the 8 women randomized but not treated were

  11. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    OpenAIRE

    Anna-Carlotta Zarski; Anna-Carlotta Zarski; Matthias Berking; David Daniel Ebert

    2018-01-01

    IntroductionGenito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an In...

  12. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    OpenAIRE

    Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

    2018-01-01

    Introduction Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce. Aim This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an...

  13. Integrated, multidisciplinary care for hand eczema: design of a randomized controlled trial and cost-effectiveness study

    Directory of Open Access Journals (Sweden)

    Boot Cécile RL

    2009-12-01

    Full Text Available Abstract Background The individual and societal burden of hand eczema is high. Literature indicates that moderate to severe hand eczema is a disease with a poor prognosis. Many patients are hampered in their daily activities, including work. High costs are related to high medical consumption, productivity loss and sick leave. Usual care is suboptimal, due to a lack of optimal instruction and coordination of care, and communication with the general practitioner/occupational physician and people involved at the workplace. Therefore, an integrated, multidisciplinary intervention involving a dermatologist, a care manager, a specialized nurse and a clinical occupational physician was developed. This paper describes the design of a study to investigate the effectiveness and cost-effectiveness of integrated care for hand eczema by a multidisciplinary team, coordinated by a care manager, consisting of instruction on avoiding relevant contact factors, both in the occupational and in the private environment, optimal skin care and treatment, compared to usual, dermatologist-led care. Methods The study is a multicentre, randomized, controlled trial with an economic evaluation alongside. The study population consists of patients with chronic, moderate to severe hand eczema, who visit an outpatient clinic of one of the participating 5 (three university and two general hospitals. Integrated, multidisciplinary care, coordinated by a care manager, including allergo-dermatological evaluation by a dermatologist, occupational intervention by a clinical occupational physician, and counselling by a specialized nurse on optimizing topical treatment and skin care will be compared with usual care by a dermatologist. The primary outcome measure is the cumulative difference in reduction of the clinical severity score HECSI between the groups. Secondary outcome measures are the patient's global assessment, specific quality of life with regard to the hands, generic quality

  14. Treatment of acute sciatica with transforaminal epidural corticosteroids and local anesthetic: design of a randomized controlled trial.

    Science.gov (United States)

    Ter Meulen, Bastiaan C; Maas, Esther T; Vyas, Amrita; van der Vegt, Marinus; de Priester, Koo; de Boer, Michiel R; van Tulder, Maurits W; Weinstein, Henry C; Ostelo, Raymond W J G

    2017-05-25

    Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However there is much debate about their safety and effectiveness. It is important to identify patients that benefit most from TESI and only few trials have yet evaluated the effects in patients with acute sciatica. We describe a prospective, randomized controlled trial (RCT), with the aim to evaluate the hypothesis that TESI plus Levobupivacaine (TESI-plus) added to oral pain medication is more effective compared to pain medication alone or compared to transforaminal injection with a local anesthetic of short duration among patients with acute sciatica. We will recruit a total of 264 patients with sciatica (sciatica should be recommended TESI-plus within the first few weeks rather than being treated with pain medication alone in order to relieve pain and improve their functioning. In case of a negative result (no relevant differences in outcome between the three study arms), pain medication will remain the mainstay of treatment in the acute stages of sciatica. Dutch National trial register: NTR4457 (March, 6th, 2014).

  15. Go4it; study design of a randomised controlled trial and economic evaluation of a multidisciplinary group intervention for obese adolescents for prevention of diabetes mellitus type 2

    Directory of Open Access Journals (Sweden)

    Weijs Peter JM

    2008-12-01

    Full Text Available Abstract Background In the Netherlands, the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed. Therefore, it is very important that programs aiming at the prevention of type 2 diabetes of obese adolescents are developed and evaluated. Methods Go4it is a multidisciplinary group treatment that focuses on: 1 increasing awareness of the current dietary and physical activity behaviour (i.e. energy balance behaviour, 2 improving diet, 3 decreasing sedentary behaviour, 4 increasing levels of physical activity, and 5 coping with difficult situations. Go4it consists of 7 sessions with an interval of 2–3 weeks. The effectiveness of the multidisciplinary group treatment compared with usual care (i.e. referral to a dietician was evaluated in a randomised controlled trial. We examined effects on BMI(sds, body composition, energy expenditure, glucose tolerance and insulin resistance (primary outcome measure, as well as dietary and physical activity behaviour and quality of life. An economic evaluation from a societal perspective was conducted alongside the randomised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care. Discussion In this paper we described a multidisciplinary treatment program (Go4it for obese adolescents and the design of a randomised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness. Trial registration Netherlands Trial Register (ISRCTN27626398.

  16. A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION: Rationale and design

    Directory of Open Access Journals (Sweden)

    Clarke Simon D

    2011-03-01

    Full Text Available Abstract Background The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD. The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study. Methods Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment, Session 2 (six weeks, atomoxetine or placebo, and Session 3 (13 weeks, cross-over after one-week washout period. The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo. Results The methodology for the ACTION study has been detailed. Conclusions The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD

  17. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868].

    Science.gov (United States)

    Besselink, Marc G H; van Santvoort, Hjalmar C; Nieuwenhuijs, Vincent B; Boermeester, Marja A; Bollen, Thomas L; Buskens, Erik; Dejong, Cornelis H C; van Eijck, Casper H J; van Goor, Harry; Hofker, Sijbrand S; Lameris, Johan S; van Leeuwen, Maarten S; Ploeg, Rutger J; van Ramshorst, Bert; Schaapherder, Alexander F M; Cuesta, Miguel A; Consten, Esther C J; Gouma, Dirk J; van der Harst, Erwin; Hesselink, Eric J; Houdijk, Lex P J; Karsten, Tom M; van Laarhoven, Cees J H M; Pierie, Jean-Pierre E N; Rosman, Camiel; Bilgen, Ernst Jan Spillenaar; Timmer, Robin; van der Tweel, Ingeborg; de Wit, Ralph J; Witteman, Ben J M; Gooszen, Hein G

    2006-04-11

    The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.

  18. Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial.

    Science.gov (United States)

    Wiggers, Jimme K; Coelen, Robert J S; Rauws, Erik A J; van Delden, Otto M; van Eijck, Casper H J; de Jonge, Jeroen; Porte, Robert J; Buis, Carlijn I; Dejong, Cornelis H C; Molenaar, I Quintus; Besselink, Marc G H; Busch, Olivier R C; Dijkgraaf, Marcel G W; van Gulik, Thomas M

    2015-02-14

    Liver surgery in perihilar cholangiocarcinoma (PHC) is associated with high postoperative morbidity because the tumor typically causes biliary obstruction. Preoperative biliary drainage is used to create a safer environment prior to liver surgery, but biliary drainage may be harmful when severe drainage-related complications deteriorate the patients' condition or increase the risk of postoperative morbidity. Biliary drainage can cause cholangitis/cholecystitis, pancreatitis, hemorrhage, portal vein thrombosis, bowel wall perforation, or dehydration. Two methods of preoperative biliary drainage are mostly applied: endoscopic biliary drainage, which is currently used in most regional centers before referring patients for surgical treatment, and percutaneous transhepatic biliary drainage. Both methods are associated with severe drainage-related complications, but two small retrospective series found a lower incidence in the number of preoperative complications after percutaneous drainage compared to endoscopic drainage (18-25% versus 38-60%, respectively). The present study randomizes patients with potentially resectable PHC and biliary obstruction between preoperative endoscopic or percutaneous transhepatic biliary drainage. The study is a multi-center trial with an "all-comers" design, randomizing patients between endoscopic or percutaneous transhepatic biliary drainage. All patients selected to potentially undergo a major liver resection for presumed PHC are eligible for inclusion in the study provided that the biliary system in the future liver remnant is obstructed (even if they underwent previous inadequate endoscopic drainage). Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy. The study is designed to detect superiority of percutaneous drainage: a provisional sample size of 106 patients is required to detect a relative decrease of 50% in the number of severe preoperative

  19. Effects of structured education program on organ donor designation of nursing students and their families: A randomized controlled trial.

    Science.gov (United States)

    Murakami, Minoru; Fukuma, Shingo; Ikezoe, Masaya; Iizuka, Chizuko; Izawa, Satoshi; Yamamoto, Yosuke; Yamazaki, Shin; Fukuhara, Shunichi

    2016-11-01

    Little is known about the effect of education programs on changing attitudes and behaviors of participants and their families toward deceased organ donation. The subjects of this randomized trial were Japanese nursing students who were not previously designated organ donors. They were randomly assigned to either the education program or information booklet group. The program comprised a lecture followed by group discussion and information booklet. The primary outcome was self-reported organ donor designation. Outcomes were assessed by questionnaire. Data of 203 (99.0%) students were analyzed. At study end, seven of 102 students (6.9%) of the program group and one of 101 students (1.0%) of the booklet group consented to donate organs (proportion ratio 6.93 [95% CI 0.87-55.32]). There were significant between-group differences in willingness to consent for donation (54.9% vs 39.6%; proportion ratio 1.39 [95% CI 1.03-1.87]), family discussion (31.4% vs 15.9%; 1.98 [1.16-3.38]), and organ donor designation of family members (11.8% vs 2.0%; 5.94 [1.36-25.88]). No group differences were found in willingness for organ donation by students and family members. Although there were no significant between-group differences in organ donor designation, the program seems to indirectly promote consent to organ donation by their families. © 2016 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

  20. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    Directory of Open Access Journals (Sweden)

    de Ruiter Marieke A

    2012-12-01

    Full Text Available Abstract Background Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Methods/Design Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35 or placebo training (n=35. Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. Discussion If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. Trial registration ClinicalTrials.gov NCT00961922.

  1. Design of a randomized controlled trial on the effects of Counseling of mental health problems by Occupational Physicians on return to work: the CO-OP-study

    Directory of Open Access Journals (Sweden)

    van Mechelen Willem

    2007-07-01

    Full Text Available Abstract Background Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care. Methods/Design In a randomized controlled trial (RCT, subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline. Discussion In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped

  2. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

    Science.gov (United States)

    Hemming, Karla; Lilford, Richard; Girling, Alan J

    2015-01-30

    Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. One modification we consider is the incomplete cross-sectional SW-CRT, where the number of clusters varies at each step or where at some steps, for example, implementation or transition periods, data are not collected. We show that the parallel CRT with staggered but balanced randomisation can be considered a special case of the incomplete SW-CRT. As too can the parallel CRT with baseline measures. And we extend these designs to allow for multiple layers of clustering, for example, wards within a hospital. Building on results for complete designs, power and detectable difference are derived using a Wald test and obtaining the variance-covariance matrix of the treatment effect assuming a generalised linear mixed model. These variations are illustrated by several real examples. We recommend that whilst the impact of transition periods on power is likely to be small, where they are a feature of the design they should be incorporated. We also show examples in which the power of a SW-CRT increases as the intra-cluster correlation (ICC) increases and demonstrate that the impact of the ICC is likely to be smaller in a SW-CRT compared with a parallel CRT, especially where there are multiple levels of clustering. Finally, through this unified framework, the efficiency of the SW-CRT and the parallel CRT can be compared. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  3. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

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    Rejeski W Jack

    2011-05-01

    Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

  4. A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

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    Schulze Kerry

    2011-04-01

    Full Text Available Abstract Background We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. Methods This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE, beta-carotene (42 mg, or ~7000 ug RE or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. Results The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and

  5. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.

    Science.gov (United States)

    Labrique, Alain B; Christian, Parul; Klemm, Rolf D W; Rashid, Mahbubur; Shamim, Abu Ahmed; Massie, Allan; Schulze, Kerry; Hackman, Andre; West, Keith P

    2011-04-21

    We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity

  6. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH: design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

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    Adams Jo

    2012-11-01

    Full Text Available Abstract Background Rheumatoid Arthritis (RA commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration Current Controlled Trials ISRCTN89936343

  7. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

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    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  8. Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: a strategy to reduce the incidence of postoperative delirium in elderly patients.

    Science.gov (United States)

    Li, Tianjing; Wieland, L Susan; Oh, Esther; Neufeld, Karin J; Wang, Nae-Yuh; Dickersin, Kay; Sieber, Frederick E

    2017-06-01

    Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others

  9. The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial.

    Science.gov (United States)

    Welschen, Laura M C; Bot, Sandra D M; Dekker, Jacqueline M; Timmermans, Daniëlle R M; van der Weijden, Trudy; Nijpels, Giel

    2010-08-05

    Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory. A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group. This innovative risk

  10. Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a prospective randomized controlled clinical trial

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    van den Akker-Scheek Inge

    2009-09-01

    Full Text Available Abstract Background Prosthetic design for the use in primary total knee arthroplasty has evolved into designs that preserve the posterior cruciate ligament (PCL and those in which the ligament is routinely sacrificed (posterior stabilized. In patients with a functional PCL the decision which design is chosen depends largely on the favour and training of the surgeon. The objective of this study is to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty. Methods/Design A randomized controlled trial will be conducted. Patients who are admitted for primary unilateral TKA due to primary osteoarthrosis are included when the following inclusion criteria are met: non-fixed fixed varus or valgus deformity less than 10 degrees, age between 55 and 85 years, body mass index less than 35 kg/m2 and ASA score (American Society of Anaesthesiologists I or II. Patients are randomized in 2 groups. Patients in the posterior cruciate retaining group will receive a prosthesis with a posterior cut-out for the posterior cruciate ligament and relatively flat topography. In patients allocated to the posterior stabilized group, in which the posterior cruciate ligament is excised, the design may substitute for this function by an intercondylar tibial prominence that articulates with the femur in flexion. Measurements will take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. At all measurement points patient's perceived outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC. Secondary outcome measures are quality of life (SF-36 and physician reported functional status and range of motion as determined with the Knee Society Clinical Rating System (KSS. Discussion In the current practice both posterior cruciate retaining and posterior stabilized designs

  11. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

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    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  12. Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial

  13. [Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study

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    Mattace-Raso Francesco US

    2011-08-01

    Full Text Available Background Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. Methods/Design A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D, costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. Discussion The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1593

  14. Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

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    Ayansina Dolapo

    2011-03-01

    Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

  15. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

    Science.gov (United States)

    Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

    2018-04-04

    Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

  16. Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling

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    Menko Fred H

    2008-10-01

    Full Text Available Abstract Background Understanding risks is considered to be crucial for informed decision-making. Inaccurate risk perception is a common finding in women with a family history of breast cancer attending genetic counseling. As yet, it is unclear how risks should best be communicated in clinical practice. This study protocol describes the design and methods of the BRISC (Breast cancer RISk Communication study evaluating the effect of different formats of risk communication on the counsellee's risk perception, psychological well-being and decision-making regarding preventive options for breast cancer. Methods and design The BRISC study is designed as a pre-post-test controlled group intervention trial with repeated measurements using questionnaires. The intervention-an additional risk consultation-consists of one of 5 conditions that differ in the way counsellee's breast cancer risk is communicated: 1 lifetime risk in numerical format (natural frequencies, i.e. X out of 100, 2 lifetime risk in both numerical format and graphical format (population figures, 3 lifetime risk and age-related risk in numerical format, 4 lifetime risk and age-related risk in both numerical format and graphical format, and 5 lifetime risk in percentages. Condition 6 is the control condition in which no intervention is given (usual care. Participants are unaffected women with a family history of breast cancer attending one of three participating clinical genetic centres in the Netherlands. Discussion The BRISC study allows for an evaluation of the effects of different formats of communicating breast cancer risks to counsellees. The results can be used to optimize risk communication in order to improve informed decision-making among women with a family history of breast cancer. They may also be useful for risk communication in other health-related services. Trial registration Current Controlled Trials ISRCTN14566836.

  17. Effectiveness of anodal transcranial direct current stimulation in patients with chronic low back pain: Design, method and protocol for a randomised controlled trial

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    Luedtke Kerstin

    2011-12-01

    Full Text Available Abstract Background Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive. Methods/Design A randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale and disability (Oswestry Disability Index. Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function, Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36, as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up. Discussion This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back

  18. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  19. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

    Science.gov (United States)

    Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

    2015-01-01

    Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials

  20. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

    Science.gov (United States)

    Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

    2014-03-01

    The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

  1. Activity and Life After Survival of a Cardiac Arrest (ALASCA and the effectiveness of an early intervention service: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bakx Wilbert GM

    2007-08-01

    Full Text Available Abstract Background Cardiac arrest survivors may experience hypoxic brain injury that results in cognitive impairments which frequently remain unrecognised. This may lead to limitations in daily activities and participation in society, a decreased quality of life for the patient, and a high strain for the caregiver. Publications about interventions directed at improving quality of life after survival of a cardiac arrest are scarce. Therefore, evidence about effective rehabilitation programmes for cardiac arrest survivors is urgently needed. This paper presents the design of the ALASCA (Activity and Life After Survival of a Cardiac Arrest trial, a randomised, controlled clinical trial to evaluate the effects of a new early intervention service for survivors of a cardiac arrest and their caregivers. Methods/design The study population comprises all people who survive two weeks after a cardiac arrest and are admitted to one of the participating hospitals in the Southern part of the Netherlands. In a two-group randomised, controlled clinical trial, half of the participants will receive an early intervention service. The early intervention service consists of several consultations with a specialised nurse for the patient and their caregiver during the first three months after the cardiac arrest. The intervention is directed at screening for cognitive problems, provision of informational, emotional and practical support, and stimulating self-management. If necessary, referral to specialised care can take place. Persons in the control group will receive the care as usual. The primary outcome measures are the extent of participation in society and quality of life of the patient one year after a cardiac arrest. Secondary outcome measures are the level of cognitive, emotional and cardiovascular impairment and daily functioning of the patient, as well as the strain for and quality of life of the caregiver. Participants and their caregivers will be followed

  2. Return to work in sick-listed cancer survivors with job loss: design of a randomised controlled trial.

    Science.gov (United States)

    van Egmond, Martine P; Duijts, Saskia F A; Vermeulen, Sylvia J; van der Beek, Allard J; Anema, Johannes R

    2015-02-18

    Despite long-term or permanent health problems, cancer survivors are often motivated to return to work. For cancer survivors who have lost their job, return to work can be more challenging compared to employed survivors, as they generally find themselves in a more vulnerable social and financial position. Cancer survivors with job loss may therefore be in need of tailored return to work support. However, there is a lack of return to work intervention programs specifically targeting these cancer survivors. The number of cancer survivors with job loss in developed countries is rising due to, amongst others, increases in the incidence and survivor rate of cancer, the retirement age and the proportion of flexible employment contracts. Hence, we consider it important to develop a tailored return to work intervention program for cancer survivors with job loss, and to evaluate its effectiveness compared to usual care. This study employs a two-armed randomised controlled trial with a follow-up period of 12 months. The study population (n = 164) will be recruited from a national sample of cancer survivors (18-60 years), who have been sick-listed for 12-36 months. Participants will be randomised by using computerized blocked randomisation (blocks of four). All participants will receive usual care as provided by the Dutch Social Security Agency. Additionally, participants in the intervention group will receive a tailored return to work intervention program, which includes vocational rehabilitation and supportive psychosocial components, as well as (therapeutic) placement at work. The primary outcome measure is duration until sustainable return to work; the secondary outcome measure is rate of return to work. Other parameters include, amongst others, fatigue, coping strategy and quality of life. We will perform Cox regression analyses to estimate hazard ratios for time to sustainable return to work. The hypothesis of this study is that a tailored approach for cancer

  3. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

    Directory of Open Access Journals (Sweden)

    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  4. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

    Directory of Open Access Journals (Sweden)

    Lemon Stephenie C

    2009-12-01

    Full Text Available Abstract Background US Latinos have greater prevalence of type 2 diabetes (diabetes, uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. Methods and design This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control on glycemic control among low-income Latinos with diabetes, compared to usual care (control. Participants were recruited from five community health centers (CHCs in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c. Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need. Trial registration http://www.clinicaltrials.gov # NCT00848315

  5. Randomized controlled trial on effectiveness of ultrasonography screening for breast cancer in women aged 40-49 (J-START). Research design

    International Nuclear Information System (INIS)

    Ohuchi, Noriaki; Ishida, Takanori; Kawai, Masaaki; Narikawa, Yoko; Yamamoto, Seiichiro; Sobue, Tomotaka

    2011-01-01

    In cancer screening, it is essential to undertake effective screening with appropriate methodology, which should be supported by evidence of a reduced mortality rate. At present, mammography is the only method for breast cancer screening with such evidence. However, mammography does not achieve sufficient accuracy in breasts with high density at ages below 50. Although ultrasonography achieves better accuracy in Breast Cancer detection even in dense breasts, the effectiveness has not been verified. We have planned a randomized controlled trial to assess the effectiveness of ultrasonography in women aged 40-49, with a design to study 50,000 women with mammography and ultrasonography (intervention group), and 50,000 controls with mammography only (control group). The participants are scheduled to take second round screening with the same modality 2 years on. The primary endpoints are sensitivity and specificity, and the secondary endpoint is the rate of advanced breast cancers. (author)

  6. Free breakfasts in schools: design and conduct of a cluster randomised controlled trial of the Primary School Free Breakfast Initiative in Wales [ISRCTN18336527

    Directory of Open Access Journals (Sweden)

    Hale Janine

    2007-09-01

    Full Text Available Abstract Background School-based breakfast provision is increasingly being seen as a means of improving educational performance and dietary behaviour amongst children. Furthermore, recognition is growing that breakfast provision offers potential as a means of addressing social inequalities in these outcomes. At present however, the evidence base on the effectiveness of breakfast provision in bringing about these improvements is limited. Methods/Design This paper describes the research design of a large scale evaluation of the effectiveness of the Welsh Assembly Government's Primary School Free Breakfast Initiative. A cluster randomised trial, with school as the unit of randomisation was used for the outcome evaluation, with a nested qualitative process evaluation. Quantitative outcome measures included dietary habits, attitudes, cognitive function, classroom behaviour, and school attendance. The study recruited 111 primary schools in Wales, of which 56 were randomly assigned to control condition and 55 to intervention. Participants were Year 5 and 6 students (aged 9–11 years in these schools. Data were collected for all 111 schools at each of three time points: baseline, 4 month and 12 month follow-up. This was achieved through a repeated cross-sectional survey of approximately 4350 students on each of these occasions. Of those students in Year 5 at baseline, 1975 provided data at one or both of the follow-ups, forming a nested cohort. The evaluation also included a nested process evaluation, using questionnaires, semi-structured interviews and case studies with students, school staff, and local authority scheme coordinators as key informants. Discussion An overview of the methods used for the evaluation is presented, providing an example of the feasibility of conducting robust evaluations of policy initiatives using a randomised trial design with nested process evaluation. Details are provided of response rates and the flow of participants

  7. 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

  8. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

    Science.gov (United States)

    Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

    2017-04-05

    Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14

  9. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors among Remote Reservation-Dwelling American Indian Adults with Type 2 Diabetes

    Science.gov (United States)

    Henderson, Jeffrey A.; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

    2012-01-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes…

  10. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China.

    Science.gov (United States)

    Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

    2015-01-01

    While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. The integrated care system needs collaborative work from different levels

  11. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients

  12. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be

  13. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion

  14. A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity: rationale, design and methodology of a randomized controlled trial in Nanjing city, China

    Directory of Open Access Journals (Sweden)

    Xu Fei

    2012-06-01

    Full Text Available Abstract Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. Methods/design We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group. Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a classroom curriculum, (including physical education and healthy diet education, b school environment support, c family involvement, and d fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. Discussion The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools’ regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. Trial registration Registration number: ChiCTR-ERC-11001819

  15. Efficacy and Safety of Sparsentan Compared With Irbesartan in Patients With Primary Focal Segmental Glomerulosclerosis: Randomized, Controlled Trial Design (DUET

    Directory of Open Access Journals (Sweden)

    Radko Komers

    2017-07-01

    Discussion: This study will provide important evidence on whether dual ARB and endothelin blockade may be an effective therapeutic strategy for FSGS and may provide the rationale for next-phase trials.

  16. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Barbosa Rafael Inácio

    2012-12-01

    Full Text Available Abstract Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec - 75ddtf / Universal Trial Number: U1111-1121-5184

  17. The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs.

    Science.gov (United States)

    Thompson, Jennifer A; Fielding, Katherine; Hargreaves, James; Copas, Andrew

    2017-12-01

    Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences. We compared the design effect of this optimised stepped wedge trial to the design effects of a parallel cluster-randomised trial, a cluster-randomised trial with baseline observations, and a hybrid trial design (a mixture of cluster-randomised trial and stepped wedge trial) with the same total cluster size for all designs. Results We found that a stepped wedge trial with an equal allocation to sequences is optimised by obtaining all observations after the first sequence switches and before the final sequence switches to the intervention; this means that the first sequence remains in the control condition and the last sequence remains in the intervention condition for the duration of the trial. With this design, the optimal number of sequences is [Formula: see text], where [Formula: see text] is the cluster-mean correlation, [Formula: see text] is the intracluster correlation coefficient, and m is the total cluster size. The optimal number of sequences is small when the intracluster correlation coefficient and cluster size are small and large when the intracluster correlation coefficient or cluster size is large. A cluster-randomised trial remains more efficient than the optimised stepped wedge trial when the intracluster correlation coefficient or cluster size is small. A

  18. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  19. Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450

    Directory of Open Access Journals (Sweden)

    Hutton JL

    2005-01-01

    Full Text Available Abstract Background The optimal management for severe sprains (Grades II and III of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1 the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot in comparison to Tubigrip®, and (2 to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. Discussion This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

  20. Control system design guide

    Energy Technology Data Exchange (ETDEWEB)

    Sellers, David; Friedman, Hannah; Haasl, Tudi; Bourassa, Norman; Piette, Mary Ann

    2003-05-01

    The ''Control System Design Guide'' (Design Guide) provides methods and recommendations for the control system design process and control point selection and installation. Control systems are often the most problematic system in a building. A good design process that takes into account maintenance, operation, and commissioning can lead to a smoothly operating and efficient building. To this end, the Design Guide provides a toolbox of templates for improving control system design and specification. HVAC designers are the primary audience for the Design Guide. The control design process it presents will help produce well-designed control systems that achieve efficient and robust operation. The spreadsheet examples for control valve schedules, damper schedules, and points lists can streamline the use of the control system design concepts set forth in the Design Guide by providing convenient starting points from which designers can build. Although each reader brings their own unique questions to the text, the Design Guide contains information that designers, commissioning providers, operators, and owners will find useful.

  1. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sonia Gaucher

    Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.

  2. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hansen Inge

    2011-12-01

    Full Text Available Abstract Background Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. Methods/Design The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control group or a combined pain management and training (interventiongroup. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36, Physical Component Summary (PCS. Secondary outcomes will be Global Perceived Effect (-5 to +5, Neck Disability Index (0-50, Patient Specific Functioning Scale (0-10, numeric rating scale for pain bothersomeness (0-10, SF-36 Mental Component Summary (MCS, TAMPA scale of Kinesiophobia (17-68, Impact of Event Scale (0-45, EuroQol (0

  3. Rationale and Design of Khuzestan Vitamin D Deficiency Screening Program in Pregnancy: A Stratified Randomized Vitamin D Supplementation Controlled Trial.

    Science.gov (United States)

    Rostami, Maryam; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Hosseinpanah, Farhad; Alavi Majd, Hamid

    2017-04-07

    according to the intention-to-treat principle. Recruitment commenced in July, 2014, and as estimated, nearly 3.5 years is needed to complete the study. Results of this study will (1) provide reliable information regarding the prevalence of vitamin D deficiency during pregnancy using universal vitamin D screening approach and (2) determine the beneficial effects of universal screening and compare the various treatment protocols in terms of pregnancy outcomes. Since vitamin D deficiency is a prevalent disorder in pregnancy among Iranian population, this study will ensure creation of reliable evidence-based findings and will enable clinicians to better evaluate and treat vitamin D deficient pregnant women. International Standard Randomized Controlled Trial Number (ISRCTN): 2014102519660N1; http://www.irct.ir/searchresult.php?keyword=&id=19660&number=1&prt=7805&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6p3lkqFdV). ©Maryam Rostami, Fahimeh Ramezani Tehrani, Masoumeh Simbar, Farhad Hosseinpanah, Hamid Alavi Majd. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.04.2017.

  4. Specific treatment of problems of the spine (STOPS: design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

    Directory of Open Access Journals (Sweden)

    Richards Matthew C

    2011-05-01

    Full Text Available Abstract Background Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. Methods/Design A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks or specific physiotherapy treatment (10 sessions over 10 weeks tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D, interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire. Adverse events and co-interventions will also be measured. Data will be

  5. Design of the OPUS School Meal Study: A randomised controlled trial assessing the impact of serving school meals based on the New Nordic Diet

    DEFF Research Database (Denmark)

    Damsgaard, Camilla T.; Dalskov, Stine-Mathilde; Petersen, Rikke A.

    2012-01-01

    Introduction: Danish children consume too much sugar and not enough whole grain, fish, fruit, and vegetables. The Nordic region is rich in such foods with a strong health-promoting potential. We lack randomised controlled trials that investigate the developmental and health impact of serving school...... meals based on Nordic foods. Aim: This paper describes the rationale, design, study population, and potential implications of the Optimal well-being, development and health for Danish children through a healthy New Nordic Diet (OPUS) School Meal Study. Methods: In a cluster-randomised cross-over design...... activity, cardiorespiratory fitness, sleep, growth, body composition, early metabolic and cardiovascular risk markers, illness, absence from school, wellbeing, cognitive function, social and cultural features, food acceptance, waste, and cost were assessed. Results: In total, 834 children (82% of those...

  6. Study protocol: the development of a randomised controlled trial testing a postcard intervention designed to reduce suicide risk among young help-seekers

    Directory of Open Access Journals (Sweden)

    McGorry Patrick

    2009-09-01

    Full Text Available Abstract Background Suicidal behaviour and deliberate self harm are common among adolescents. Limited evidence exists regarding interventions that can reduce risk; however research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from services can reduce risk. The aim of the study is to test a postcard intervention among people aged 15-24 who presented to mental health services but are not accepted, yet are at risk of suicide. Methods/design The study is a 3-year randomised controlled trial conducted at Orygen Youth Health Research Centre in Melbourne Australia. Participants are young help-seekers aged 15-24 who are at risk of suicide. Participants will be recruited over a 12 month period. The intervention comprises a regular postcard to be sent monthly for 12 months. The postcard enquires after their well being and includes information regarding individual sources of help and evidence-based self help strategies. Participants are assessed at baseline, 12 and 18 months. Discussion This paper describes the development of a study which aims to reduce suicide risk in a sample of young help-seekers. If effective, this intervention could have significant clinical and research implications for a population who can be hard to treat and difficult to research. Trial Registration The study was registered with the Australian Clinical Trials Registry; number: ACTRN012606000274572.

  7. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters

    Directory of Open Access Journals (Sweden)

    Duhem Stephane

    2011-01-01

    Full Text Available Abstract Background Suicide attempts (SA constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Methods/Design Multicentre randomized controlled trial. We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters and «Crisis card» (effective only in first-attempters. Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards». Discussion ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy. Trial Registration The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174.

  8. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  9. A community randomised controlled trial evaluating a home-based environmental intervention package of improved stoves, solar water disinfection and kitchen sinks in rural Peru: rationale, trial design and baseline findings.

    Science.gov (United States)

    Hartinger, S M; Lanata, C F; Hattendorf, J; Gil, A I; Verastegui, H; Ochoa, T; Mäusezahl, D

    2011-11-01

    Pneumonia and diarrhoea are leading causes of death in children. There is a need to develop effective interventions. We present the design and baseline findings of a community-randomised controlled trial in rural Peru to evaluate the health impact of an Integrated Home-based Intervention Package in children aged 6 to 35 months. We randomised 51 communities. The intervention was developed through a community-participatory approach prior to the trial. They comprised the construction of improved stoves and kitchen sinks, the promotion of hand washing, and solar drinking water disinfection (SODIS). To reduce the potential impact of non-blinding bias, a psychomotor stimulation intervention was implemented in the control arm. The baseline survey included anthropometric and socio-economic characteristics. In a sub-sample we determined the level of faecal contamination of drinking water, hands and kitchen utensils and the prevalence of diarrhoegenic Escherichia coli in stool specimen. We enrolled 534 children. At baseline all households used open fires and 77% had access to piped water supplies. E. coli was found in drinking water in 68% and 64% of the intervention and control households. Diarrhoegenic E. coli strains were isolated from 45/139 stool samples. The proportion of stunted children was 54%. Randomization resulted in comparable study arms. Recently, several critical reviews raised major concerns on the reliability of open health intervention trials, because of uncertain sustainability and non-blinding bias. In this regard, the presented trial featuring objective outcome measures, a simultaneous intervention in the control communities and a 12-month follow up period will provide valuable evidence. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design

    DEFF Research Database (Denmark)

    Petri, N.; Svanholt, P.; Solow, B.

    2008-01-01

    The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non......). Eighty-one patients (87%) completed the trial. The MAA group achieved mean AHI and Epworth scores significantly lower (P group and the no-intervention group. No significant differences were found between the MNA group and the no-intervention group. The MAA group had...

  11. The GO-ACTIWE randomized controlled trial - An interdisciplinary study designed to investigate the health effects of active commuting and leisure time physical activity

    DEFF Research Database (Denmark)

    Rosenkilde, Mads; Petersen, Martin Bæk; Gram, Anne Sofie

    2017-01-01

    represents a promising alternative to increase physical activity, but it has yet to be established whether active commuting conveys health benefits on par with leisure time physical activity (LTPA). A 6-month randomized controlled trial was designed to investigate the effects of increased physical activity......Regular physical activity is efficacious for improving metabolic health in overweight and obese individuals, yet, many adults lead sedentary lives. Most exercise interventions have targeted leisure time, but physical activity also takes place in other domains of everyday life. Active commuting...... in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise). We included 188 overweight and class 1 obese sedentary women and men (20-45years) of which 130 were randomized to either sedentary controls (n=18), active commuting (n=35) or moderate (n=39) or vigorous (n=38...

  12. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  13. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

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    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  14. Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

    Science.gov (United States)

    Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S M

    2018-01-01

    Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

    Directory of Open Access Journals (Sweden)

    Gill Paramjit

    2009-08-01

    Full Text Available Abstract Background The prevalence of smoking is higher among Pakistani and Bangladeshi males than among the general population. Smokers who receive behavioural support and medication quadruple their chances of stopping smoking, but evidence suggests that these populations do not use National Health Service run stop smoking clinics as frequently as would be expected given their high prevalence of smoking. This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach' with standard care ('clinic only' to improve access to and success of National Health Service smoking cessation services. Methods/design This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregated agglomerations of super output areas will be identified, separating areas from each other using buffer regions in order to reduce potential contamination. These natural communities will be randomised to 'clinic + outreach' (intervention or 'clinic only' (control arms. The use of stop smoking services and the numbers of people quitting smoking (defined as prolonged self-reported abstinence at four weeks, three months and six months will be assessed in each area. In addition, we will assess the impact of the intervention on adherence to smoking cessation treatments and patient satisfaction. Trial registration Current Controlled Trials ISRCTN 82127540.

  16. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

    2013-10-25

    A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster

  18. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study: rationales and study design

    Directory of Open Access Journals (Sweden)

    Liu Li

    2012-09-01

    that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis. Trial registration Current Controlled Trials NCT01509937

  19. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an integral person

  20. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van de Ven Geertje

    2012-01-01

    Full Text Available Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an

  1. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Science.gov (United States)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  2. Adaptive design methods in clinical trials – a review

    Directory of Open Access Journals (Sweden)

    Chang Mark

    2008-05-01

    Full Text Available Abstract In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc, and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments, challenges in by design (prospective adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed.

  3. The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

    Directory of Open Access Journals (Sweden)

    van Dijk Frank JH

    2011-05-01

    Full Text Available Abstract Background Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS mental module may be an effective strategy to monitor and promote good (mental health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. Methods The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in

  4. Group sequential designs for stepped-wedge cluster randomised trials.

    Science.gov (United States)

    Grayling, Michael J; Wason, James Ms; Mander, Adrian P

    2017-10-01

    The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into

  5. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

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    Puig-Ribera Anna

    2009-01-01

    Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

  6. Free breakfasts in schools: design and conduct of a cluster randomised controlled trial of the Primary School Free Breakfast Initiative in Wales [ISRCTN18336527].

    Science.gov (United States)

    Moore, Laurence; Moore, Graham F; Tapper, Katy; Lynch, Rebecca; Desousa, Carol; Hale, Janine; Roberts, Chris; Murphy, Simon

    2007-09-21

    School-based breakfast provision is increasingly being seen as a means of improving educational performance and dietary behaviour amongst children. Furthermore, recognition is growing that breakfast provision offers potential as a means of addressing social inequalities in these outcomes. At present however, the evidence base on the effectiveness of breakfast provision in bringing about these improvements is limited. This paper describes the research design of a large scale evaluation of the effectiveness of the Welsh Assembly Government's Primary School Free Breakfast Initiative. A cluster randomised trial, with school as the unit of randomisation was used for the outcome evaluation, with a nested qualitative process evaluation. Quantitative outcome measures included dietary habits, attitudes, cognitive function, classroom behaviour, and school attendance. The study recruited 111 primary schools in Wales, of which 56 were randomly assigned to control condition and 55 to intervention. Participants were Year 5 and 6 students (aged 9-11 years) in these schools. Data were collected for all 111 schools at each of three time points: baseline, 4 month and 12 month follow-up. This was achieved through a repeated cross-sectional survey of approximately 4350 students on each of these occasions. Of those students in Year 5 at baseline, 1975 provided data at one or both of the follow-ups, forming a nested cohort. The evaluation also included a nested process evaluation, using questionnaires, semi-structured interviews and case studies with students, school staff, and local authority scheme coordinators as key informants. An overview of the methods used for the evaluation is presented, providing an example of the feasibility of conducting robust evaluations of policy initiatives using a randomised trial design with nested process evaluation. Details are provided of response rates and the flow of participants. Reflection is offered on methodological issues encountered at

  7. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

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    Vonk Noordegraaf Antonie

    2012-02-01

    Full Text Available Abstract Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR: NTR2087

  8. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

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    Bartels Ronald HMA

    2013-01-01

    Full Text Available Abstract Background Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. Methods/Design A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care, duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. Discussion At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Trial Registration Gov: NCT01367405

  9. Can an EASYcare based dementia training programme improve diagnostic assessment and management of dementia by general practitioners and primary care nurses? The design of a randomised controlled trial

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    Lucassen PL

    2008-04-01

    Full Text Available Abstract Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed. Some educational interventions developed to improve dementia diagnosis and management were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed an EASYcare-based Dementia Training Program (DTP aimed at stimulating collaboration in dementia primary care. We expect this program to increase the number of cognitive assessments and dementia diagnoses and to improve attitudes and knowledge of GPs and nurses. Methods The DTP is a complex educational intervention that consists of two workshops, a coaching program, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics. One hundred duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in a cluster-randomised controlled trial. Primary outcomes will be the number of cognitive assessments and dementia diagnoses in a period of 9 months following workshop participation. Secondary outcomes are measured on GP and nurse level: adherence to national guidelines for dementia, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical records, self-registration forms and questionnaires. Statistical analysis will be performed using the MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and

  10. The Study of HIV and Antenatal Care Integration in Pregnancy in Kenya: Design, Methods, and Baseline Results of a Cluster-Randomized Controlled Trial

    Science.gov (United States)

    Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Bukusi, Elizabeth A.; Woods, Meghan; Shade, Starley B.; Washington, Sierra; Marima, Reson; Penner, Jeremy; Ackers, Marta L.; Mbori-Ngacha, Dorothy; Cohen, Craig R.

    2012-01-01

    Background Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. Methodology/Principal Findings A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009– March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. Conclusions/Significance This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery

  11. Design of a Randomised Controlled Trial (RCT on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

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    Annema Coby

    2010-05-01

    Full Text Available Abstract Background Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS patients and their caregivers compared to usual care. Methods/design In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. Discussion This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1 the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2 we included patients with complex care situations and/or were at risk for critical situations; 3 the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4 case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5 the

  12. Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial

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    van der Heijden Marion MP

    2012-07-01

    Full Text Available Abstract Background Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM, as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account. Methods/Design This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands. Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of depression, exercise self-efficacy, Body Mass Index (BMI, blood pressure and glycemic control. Discussion We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the

  13. Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial.

    Science.gov (United States)

    Kilburn, Tina R; Sørensen, Merete Juul; Thastum, Mikael; Rapee, Ronald M; Rask, Charlotte Ulrikka; Arendt, Kristian Bech; Thomsen, Per Hove

    2018-04-02

    Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016.

  14. Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling.

    Science.gov (United States)

    Ockhuysen-Vermey, Caroline F; Henneman, Lidewij; van Asperen, Christi J; Oosterwijk, Jan C; Menko, Fred H; Timmermans, Daniëlle R M

    2008-10-03

    Understanding risks is considered to be crucial for informed decision-making. Inaccurate risk perception is a common finding in women with a family history of breast cancer attending genetic counseling. As yet, it is unclear how risks should best be communicated in clinical practice. This study protocol describes the design and methods of the BRISC (Breast cancer RISk Communication) study evaluating the effect of different formats of risk communication on the counsellee's risk perception, psychological well-being and decision-making regarding preventive options for breast cancer. The BRISC study is designed as a pre-post-test controlled group intervention trial with repeated measurements using questionnaires. The intervention-an additional risk consultation-consists of one of 5 conditions that differ in the way counsellee's breast cancer risk is communicated: 1) lifetime risk in numerical format (natural frequencies, i.e. X out of 100), 2) lifetime risk in both numerical format and graphical format (population figures), 3) lifetime risk and age-related risk in numerical format, 4) lifetime risk and age-related risk in both numerical format and graphical format, and 5) lifetime risk in percentages. Condition 6 is the control condition in which no intervention is given (usual care). Participants are unaffected women with a family history of breast cancer attending one of three participating clinical genetic centres in the Netherlands. The BRISC study allows for an evaluation of the effects of different formats of communicating breast cancer risks to counsellees. The results can be used to optimize risk communication in order to improve informed decision-making among women with a family history of breast cancer. They may also be useful for risk communication in other health-related services. Current Controlled Trials ISRCTN14566836.

  15. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Science.gov (United States)

    2012-01-01

    Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784). PMID:22439919

  16. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Directory of Open Access Journals (Sweden)

    Bröning Sonja

    2012-03-01

    Full Text Available Abstract Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784.

  17. The design of instructional tools affects secondary school students' learning of cardiopulmonary resuscitation (CPR) in reciprocal peer learning: a randomized controlled trial.

    Science.gov (United States)

    Iserbyt, Peter; Byra, Mark

    2013-11-01

    Research investigating design effects of instructional tools for learning Basic Life Support (BLS) is almost non-existent. To demonstrate the design of instructional tools matter. The effect of spatial contiguity, a design principle stating that people learn more deeply when words and corresponding pictures are placed close (i.e., integrated) rather than far from each other on a page was investigated on task cards for learning Cardiopulmonary Resuscitation (CPR) during reciprocal peer learning. A randomized controlled trial. A total of 111 students (mean age: 13 years) constituting six intact classes learned BLS through reciprocal learning with task cards. Task cards combine a picture of the skill with written instructions about how to perform it. In each class, students were randomly assigned to the experimental group or the control. In the control, written instructions were placed under the picture on the task cards. In the experimental group, written instructions were placed close to the corresponding part of the picture on the task cards reflecting application of the spatial contiguity principle. One-way analysis of variance found significantly better performances in the experimental group for ventilation volumes (P=.03, ηp2=.10) and flow rates (P=.02, ηp2=.10). For chest compression depth, compression frequency, compressions with correct hand placement, and duty cycles no significant differences were found. This study shows that the design of instructional tools (i.e., task cards) affects student learning. Research-based design of learning tools can enhance BLS and CPR education. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  18. 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

  19. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    Directory of Open Access Journals (Sweden)

    Thompson Simon

    2002-01-01

    Full Text Available Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT, unparalleled in telemedicine research in either scale or range of outcomes. The study investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing to perform joint tele-consultations as an alternative to general practitioner referral to the hospital specialist in the outpatient clinic. Methods Joint tele-consultation services were established in both the Royal Free Hampstead NHS Trust in inner London, and the Royal Shrewsbury Hospitals Trust, in Shropshire. All the patients who gave consent to participate were randomised either to joint tele-consultation or to a routine outpatients appointment. The principal outcome measures included the frequency of decision by the specialist to offer a follow-up outpatient appointment, patient satisfaction (Ware Specific Questionnaire, wellbeing (SF12 and enablement (PEI, numbers of tests, investigations, procedures and treatments. Results A total of 134 general practitioners operating from 29 practices participated in the trial, referring a total of 3170 patients to 20 specialists in ENT medicine, general medicine (including endocrinology, and rheumatology, gastroenterology, orthopaedics, neurology and urology. Of these, 2094 patients consented to participate in the study and were correctly randomised. There was a 91% response rate to the initial assessment questionnaires, and analysis showed equivalence for all key characteristics between the treatment and control groups. Conclusion We have designed and

  20. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    Science.gov (United States)

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

  1. Addressing risk factors for child abuse among high risk pregnant women: design of a randomised controlled trial of the nurse family partnership in Dutch preventive health care

    Directory of Open Access Journals (Sweden)

    Mejdoubi Jamila

    2011-10-01

    Full Text Available Abstract Background Low socio-economic status combined with other risk factors affects a person's physical and psychosocial health from childhood to adulthood. The societal impact of these problems is huge, and the consequences carry on into the next generation(s. Although several studies show these consequences, only a few actually intervene on these issues. In the United States, the Nurse Family Partnership focuses on high risk pregnant women and their children. The main goal of this program is primary prevention of child abuse. The Netherlands is the first country outside the United States allowed to translate and culturally adapt the Nurse Family Partnership into VoorZorg. The aim of the present study is to assess whether VoorZorg is as effective in the Netherland as in the United States. Methods The study consists of three partly overlapping phases. Phase 1 was the translation and cultural adaptation of Nurse Family Partnership and the design of a two-stage selection procedure. Phase 2 was a pilot study to examine the conditions for implementation. Phase 3 is the randomized controlled trial of VoorZorg compared to the care as usual. Primary outcome measures were smoking cessation during pregnancy and after birth, birth outcomes, child development, child abuse and domestic violence. The secondary outcome measure was the number of risk factors present. Discussion This study shows that the Nurse Family Partnership was successfully translated and culturally adapted into the Dutch health care system and that this program fulfills the needs of high-risk pregnant women. We hypothesize that this program will be effective in addressing risk factors that operate during pregnancy and childhood and compromise fetal and child development. Trial registration Current Controlled Trials ISRCTN16131117

  2. The GRONORUN 2 study: effectiveness of a preconditioning program on preventing running related injuries in novice runners. The design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bredeweg Steef W

    2010-09-01

    Full Text Available Abstract Background Distance running is a popular recreational exercise. It is a beneficial activity for health and well being. However, running may also cause injuries, especially of the lower extremities. In literature there is no agreement what intrinsic and extrinsic factors cause running related injuries (RRIs. In theory, most RRIs are elicited by training errors, this too much, too soon. In a preconditioning program runners can adapt more gradually to the high mechanical loads of running and will be less susceptible to RRIs. In this study the effectiveness of a 4-week preconditioning program on the incidence of RRIs in novice runners prior to a training program will be studied. Methods/Design The GRONORUN 2 (Groningen Novice Running study is a two arm randomized controlled trial studying the effect of a 4-week preconditioning (PRECON program in a group of novice runners. All participants wanted to train for the recreational Groningen 4-Mile running event. The PRECON group started a 4-week preconditioning program with walking and hopping exercises 4 weeks before the start of the training program. The control (CON and PRECON group started a frequently used 9-week training program in preparation for the Groningen 4-Mile running event. During the follow up period participants registered their running exposure, other sporting activities and running related injuries in an Internet based running log. The primary outcome measure was the number of RRIs. RRI was defined as a musculoskeletal ailment or complaint of the lower extremities or back causing a restriction on running for at least three training sessions. Discussion The GRONORUN 2 study will add important information to the existing running science. The concept of preconditioning is easy to implement in existing training programs and will hopefully prevent RRIs especially in novice runners. Trial registration The Netherlands National Trial Register NTR1906. The NTR is part of the WHO Primary

  3. A school-based intervention to promote physical activity among adolescent girls: Rationale, design, and baseline data from the Girls in Sport group randomised controlled trial

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    Puglisi Lauren

    2011-08-01

    Full Text Available Abstract Background Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA among adolescent girls. Methods/Design A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the primary objective (preventing the decline in accelerometer-derived MVPA. Academic partners and the State Department of Education and Training act as critical friends. Control schools continue with their usual school programming. 24 schools were matched then randomized into intervention (n = 12 and control (n = 12 groups. A total of 1518 girls (771 intervention and 747 control completed baseline assessments (86% response rate. Useable accelerometer data (≥10 hrs/day on at least 3 days were obtained from 79% of this sample (n = 1199. Randomisation resulted in no differences between intervention and control groups on any of the outcomes. The mean age (SE of the sample was 13.6 (± 0.02 years and they spent less than 5% of their waking hours in MVPA (4.85 ± 0.06. Discussion Girls in Sport will test the effectiveness of schools working towards the same goal, but developing individual, targeted interventions that bring about changes in curriculum, school environment and policy, and community links. By using community-based participatory research and an action learning framework in a secondary school setting, it aims to add to the body of literature on effective school

  4. Web-based cognitive behavioural therapy (W-CBT for diabetes patients with co-morbid depression: Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Pouwer Frans

    2008-02-01

    Full Text Available Abstract Background Depression is common among people with diabetes, negatively affecting quality of life, treatment adherence and diabetes outcomes. In routine clinical care, diabetes patients have limited access to mental health services and depression therefore often remains untreated. Web-based therapy could potentially be an effective way to improve the reach of psychological care for diabetes patients, at relatively low costs. This study seeks to test the effectiveness of a web-based self-help depression programme for people with diabetes and co-morbid depression. Methods/Design The effectiveness of a web-based self-help course for adults with diabetes with co-morbid depression will be tested in a randomised trial, using a wait-list controlled design. The intervention consists of an 8-week, moderated self-help course that is tailored to the needs of persons living with diabetes and is offered on an individual basis. Participants receive feedback on their homework assignments by e-mail from their coach. We aim to include 286 patients (143/143, as power analyses showed that this number is needed to detect an effect size of 0.35, with measurements at baseline, directly after completing the web-based intervention and at 1, 3, 4 and 6 months follow-up. Patients in the control condition are placed on a waiting list, and follow the course 12 weeks after randomisation. Primary outcomes are depressive symptoms and diabetes-specific emotional distress. Secondary outcomes are satisfaction with the course, perceived health status, self-care behaviours, glycaemic control, and days in bed/absence from work. Questionnaires are administered via the Internet. Discussion The intervention being trialled is expected to help improve mood and reduce diabetes-specific emotional distress in diabetes patients with depression, with subsequent beneficial effects on diabetes self-care and glycaemic outcomes. When proven efficacious, the intervention could be

  5. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment.

    Science.gov (United States)

    Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin

    2016-07-26

    Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By

  6. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial.

    Science.gov (United States)

    Varekamp, Inge; de Vries, Gabe; Heutink, Annelies; van Dijk, Frank J H

    2008-11-04

    Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. DEVELOPMENT AND DESCRIPTION OF INTERVENTION: A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1) Consequences of a chronic disease in the workplace, 2) Insight into feelings and thoughts about having a chronic disease, 3) Communication in daily work situations, 4) Facilities for disabled employees and work disability legislation, 5) How to stand up for oneself, 6) A plan to solve problems, 7) Follow-up. Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8, 12 and 24 months. Primary outcome

  7. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial.

    Science.gov (United States)

    Hassan, Siba E; Hajeer, Mohammad Y; Alali, Osama H; Kaddah, Ayham S

    2016-06-01

    The results of previous studies about the efficacy of using self-ligating brackets (SLBs) in controlling canine movement during retraction are not in harmony. Therefore, the current study aimed to compare the effects of using new passive SLBs on maxillary canine retraction with sliding mechanics vs conventional ligating brackets (CLBs) tied with metal ligatures. The sample comprised 15 adult patients (4 males, 11 females; 18-24 years) requiring bilateral extraction of maxillary first premolars. Units of randomization are the left or right maxillary canines within the same patient. The two maxillary canines in each patient were randomly assigned to one of the two groups in a simple split-mouth design. The canines in the SLBs group (n = 15) were bracketed with SLBs (Damon Q™), while the canines in the CLBs group (n = 15) were bracketed with conventional brackets (Mini Master Series). Transpalatal bars were used for anchorage. After leveling and alignment, 0.019 × 0.025" stainless steel working archwires were placed. Canines were retracted using a nickel-titanium close-coil springs with a 150 gm force. The amount and rate of maxillary canine retraction, canine rotation, and loss of anchorage were measured on study models collected at the beginning of canine retraction (T0) and 12 weeks later (T1). Differences were analyzed using paired-samples t-tests. The effect differences were statistically significant (p brackets gave better results compared to the CLBs in terms of rate of movement, amount of canine rotation following extraction, and anchorage loss.

  8. Healthy Children, Strong Families 2: A randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches.

    Science.gov (United States)

    Tomayko, Emily J; Prince, Ronald J; Cronin, Kate A; Parker, Tassy; Kim, Kyungmann; Grant, Vernon M; Sheche, Judith N; Adams, Alexandra K

    2017-04-01

    Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention ( Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group ( Safety Journey) for 1 year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities' request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities' request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active

  9. Strengthening the delivery of asthma and chronic obstructive pulmonary disease care at primary health-care facilities: study design of a cluster randomized controlled trial in Pakistan

    Directory of Open Access Journals (Sweden)

    Muhammad Amir Khan

    2015-11-01

    Full Text Available Background: Respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD, account for one-fourth of the patients at the primary health-care (PHC facilities in Pakistan. Standard care practices to manage these diseases are necessary to reduce the morbidity and mortality rate associated with non-communicable diseases in developing countries. Objective: To develop and measure the effectiveness of operational guidelines and implementation materials, with sound scientific evidence, for expanding lung health care, especially asthma and COPD through PHC facilities already strengthened for tuberculosis (TB care in Pakistan. Design: A cluster randomized controlled trial with two arms (intervention and control, with qualitative and costing study components, is being conducted in 34 clusters; 17 clusters per arm (428 asthma and 306 COPD patients, in three districts in Pakistan from October 2014 to December 2016. The intervention consists of enhanced case management of asthma and COPD patients through strengthening of PHC facilities. The main outcomes to be measured are asthma and COPD control among the registered cases at 6 months. Cluster- and individual-level analyses will be done according to intention to treat. Residual confounding will be addressed by multivariable logistic and linear regression models for asthma and COPD control, respectively. The trial is registered with ISRCTN registry (ISRCTN 17409338. Conclusions: Currently, only about 20% of the estimated prevalent asthma and COPD cases are being identified and reported through the respective PHC network. Lung health care and prevention has not been effectively integrated into the core PHC package, although a very well-functioning TB program exists at the PHC level. Inclusion of these diseases in the already existent TB program is expected to increase detection rates and care for asthma and COPD.

  10. Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD

    DEFF Research Database (Denmark)

    Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller

    2015-01-01

    Background: Case management interventions are recommended to improve quality of care and reduce costs in chronic care, but further evidence on effectiveness and cost-effectiveness is needed. The objective of this study is the reporting of the design and participant enrollment of a randomized...... controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result...... patients were randomized into two groups: the case-managed group and the usual-care group. Participant characteristics were obtained at baseline, and measures on effectiveness and costs were obtained through questionnaires and registries within a 12-month follow-up period. In the forthcoming analysis...

  11. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    DEFF Research Database (Denmark)

    Ris Hansen, Inge; Søgaard, Karen; Christensen, Robin Daniel Kjersgaard

    2011-01-01

    scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm......ABSTRACT: BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective...... is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients...

  12. Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651

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    Anema Johannes R

    2007-09-01

    Full Text Available Abstract Background Chronic low back pain (LBP is a major public and occupational health problem, which is associated with very high costs. Although medical costs for chronic LBP are high, most costs are related to productivity losses due to sick leave. In general, the prognosis for return to work (RTW is good but a minority of patients will be absent long-term from work. Research shows that work related problems are associated with an increase in seeking medical care and sick leave. Usual medical care of patients is however, not specifically aimed at RTW. The objective is to present the design of a randomized controlled trial, i.e. the BRIDGE-study, evaluating the effectiveness in improving RTW and cost-effectiveness of a multidisciplinary outpatient care program situated in both primary and outpatient care setting compared with usual clinical medical care for patients with chronic LBP. Methods/Design The design is a randomized controlled trial with an economic evaluation alongside. The study population consists of patients with chronic LBP who are completely or partially sick listed and visit an outpatient clinic of one of the participating hospitals in Amsterdam (the Netherlands. Two interventions will be compared. 1. a multidisciplinary outpatient care program consisting of a workplace intervention based on participatory ergonomics, and a graded activity program using cognitive behavioural principles. 2. usual care provided by the medical specialist, the occupational physician, the patient's general practitioner and allied health professionals. The primary outcome measure is sick leave duration until full RTW. Sick leave duration is measured monthly by self-report during one year. Data on sick leave during one-year follow-up are also requested form the employers. Secondary outcome measures are pain intensity, functional status, pain coping, patient satisfaction and quality of life. Outcome measures are assessed before randomization and 3, 6

  13. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina: study design of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Niederer Iris

    2009-03-01

    life and signs of hyperactivity (questionnaires, attention and spatial working memory ability (two validated tests. Researchers were blinded to group allocation. Discussion The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration Trial Registration: clinicaltrials.gov NCT00674544

  14. Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Rens Ger HMB

    2010-03-01

    Full Text Available Abstract Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122 were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension, patients' skills to operate the CCTV, perceived (vision-related quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031

  15. Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies on treatment of depression

  16. Evaluating an intervention to reduce fear of falling and associated activity restriction in elderly persons: design of a randomised controlled trial [ISRCTN43792817

    Directory of Open Access Journals (Sweden)

    van Eijk JThM

    2005-03-01

    Full Text Available Abstract Background Fear of falling and associated activity restriction is common in older persons living in the community. Adverse consequences of fear of falling and associated activity restriction, like functional decline and falls, may have a major impact on physical, mental and social functioning of these persons. This paper presents the design of a trial evaluating a cognitive behavioural group intervention to reduce fear of falling and associated activity restriction in older persons living in the community. Methods/design A two-group randomised controlled trial was developed to evaluate the intervention. Persons 70 years of age or over and still living in the community were eligible for study if they experienced at least some fear of falling and associated activity restriction. A random community sample of elderly people was screened for eligibility; those eligible for study were measured at baseline and were subsequently allocated to the intervention or control group. Follow-up measurements were carried out directly after the intervention period, and then at six months and 12 months after the intervention. People allocated to the intervention group were invited to participate in eight weekly sessions of two hours each and a booster session. This booster session was conducted before the follow-up measurement at six months after the intervention. People allocated to the control group received no intervention as a result of this trial. Both an effect evaluation and a process evaluation were performed. The primary outcome measures of the effect evaluation are fear of falling, avoidance of activity due to fear of falling, and daily activity. The secondary outcome measures are perceived general health, self-rated life satisfaction, activities of daily life, feelings of anxiety, symptoms of depression, social support interactions, feelings of loneliness, falls, perceived consequences of falling, and perceived risk of falling. The outcomes of

  17. Prevention of depression and anxiety in later life: design of a randomized controlled trial for the clinical and economic evaluation of a life-review intervention

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    Smit Filip

    2009-07-01

    Full Text Available Abstract Background Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic affordable. Methods and design This paper describes the design of a study evaluating "The stories we live by", a preventive life-review group intervention, which was recently developed for adults of 55 years and over with depressive and anxiety symptoms. Both clinical and economic effectiveness will be evaluated in a pragmatic randomized controlled trial. The participants in the intervention condition will receive the 8-session preventive intervention. The participants in the control condition will have access to usual care. Clinical end-terms are depressive and anxiety symptoms, current major depressive episode, quality of life and positive mental health post-treatment (3 months after baseline and at follow-ups (6 and 12 months after baseline. Additional goals of this study are to identify groups for whom the intervention is particularly effective and to identify the therapeutic pathways that are vital in inducing clinical change. This will be done by analyzing if treatment response is moderated by demographics, personality, past major depressive episodes, important life events and chronically disease, and mediated by reminiscence functions, perceived control, automatic positive thoughts and meaning in life. Finally the cost-effectiveness of the intervention relative to care as usual will be assessed by computing incremental costs per case of depression and anxiety avoided (cost-effectiveness and per quality adjusted life year (QALY (cost utility. Discussion It is expected that both the life-review intervention and its evaluation will contribute to the existing body of knowledge in several ways. First, the intervention is unique in linking life

  18. Food2Learn: Randomized control trial investigating influence of krill oil supplementation on learning, cognition, and behaviour in healthy adolescents. Design presentation

    NARCIS (Netherlands)

    Van der Wurff, Inge; Von Schacky, Clemens; Berge, Kjetil; Kirschner, Paul A.; De Groot, Renate

    2014-01-01

    Food2Learn is a double blind randomized controlled trial which looks at the influence of Krill oil (rich in LCPUFA) on the cognitive performance, academic performance and mental well-being of student of lower vocational schools.

  19. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  20. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  1. The Counseling Older Adults to Control Hypertension (COACH) Trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults

    OpenAIRE

    Ogedegbe, Gbenga; Fernandez, Senaida; Luerassi, Leanne; Silver, Stephanie A.; Kong, Jian; Midberry, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A.

    2013-01-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 2...

  2. Effect of Keishibukuryogan on Endothelial Function in Patients with at Least One Component of the Diagnostic Criteria for Metabolic Syndrome: A Controlled Clinical Trial with Crossover Design

    Directory of Open Access Journals (Sweden)

    Yutaka Nagata

    2012-01-01

    Full Text Available We evaluated the effect of keishibukuryogan (KBG; Guizhi-Fuling-Wan, a traditional Japanese (Kampo formula, on endothelial function assessed by reactive hyperemia peripheral arterial tonometry (Endo-PAT2000 in patients with metabolic syndrome-related factors by controlled clinical trial with crossover design. Ninety-two patients were assigned to group A (first KBG-treatment period, then control period; each lasting 4 weeks, with about one-year interval or group B (first control, then KBG-treatment. In forty-nine (27, group A; 22, group B patients completing all tests, the mean value of the natural logarithmic-scaled reactive hyperemia index (L_RHI increased and those of serum nonesterified fatty acid (NEFA, malondialdehyde, and soluble vascular cell adhesion molecule 1 decreased significantly during the KBG-treatment period, but not during the control period, and 4-week changes of L_RHI, NEFA, and malondialdehyde between the 2 periods showed significance. These results suggest that KBG has beneficial effect on endothelial function in patients with metabolic syndrome-related factors.

  3. Rationale and design of FORTH: a randomised controlled trial assessing the effectiveness of HIV self-testing in increasing HIV testing frequency among gay and bisexual men.

    Science.gov (United States)

    Jamil, Muhammad S; Prestage, Garrett; Fairley, Christopher K; Smith, Kirsty S; Kaldor, John M; Grulich, Andrew E; McNulty, Anna M; Chen, Marcus; Holt, Martin; Conway, Damian P; Wand, Handan; Keen, Phillip; Batrouney, Colin; Bradley, Jack; Bavinton, Benjamin R; Ryan, Dermot; Russell, Darren; Guy, Rebecca J

    2015-12-10

    Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability. Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia

  4. The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Diercks Ron L

    2011-10-01

    Full Text Available Abstract Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion

  5. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    International Nuclear Information System (INIS)

    Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S; Skovlund, Eva; Fosså, Sophie D

    2012-01-01

    Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass) measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness) assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life) assessed by questionnaires. Muscle cellular outcomes are a) muscle fiber size b) regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy) and c) regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes are measured on muscle cross sections and

  6. A cluster-randomized, controlled trial of nutritional supplementation and promotion of responsive parenting in Madagascar: the MAHAY study design and rationale

    Directory of Open Access Journals (Sweden)

    Lia C. H. Fernald

    2016-06-01

    Full Text Available Abstract Background Over half of the world’s children suffer from poor nutrition, and as a consequence they experience delays in physical and mental health, and cognitive development. There is little data evaluating the effects of delivery of lipid-based, nutrition supplementation on growth and development during pregnancy and early childhood within the context of a scaled-up program. Furthermore, there is limited evidence on effects of scaled-up, home-visiting programs that focus on the promotion of child development within the context of an existing, national nutrition program. Methods/Design The MAHAY ("smart" in Malagasy study uses a multi-arm randomized-controlled trial (RCT to test the effects and cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0 existing program with monthly growth monitoring and nutritional/hygiene education; (T1 is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2 is T1 + lipid-based supplementation (LNS for children 6–18 months old; (T3 is T2 + LNS supplementation of pregnant/lactating women; and (T4 is T1 + intensive home visiting program to support child development. There are anticipated to be n = 25 communities in each arm (n = 1250 pregnant women, n = 1250 children 0–6 months old, and n = 1250 children 6–18 months old. Primary outcomes include growth (length/height-for-age z-scores and child development (mental, motor and social development. Secondary outcomes include care-giver reported child morbidity, household food security and diet diversity, micro-nutrient status, maternal knowledge of child care and feeding practices, and home stimulation practices. We will estimate unadjusted and adjusted intention-to-treat effects. Study protocols have been reviewed and approved by the Malagasy Ethics Committee at the Ministry of Health in Madagascar and by

  7. The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Janet M Turan

    Full Text Available Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT, HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment. During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving

  8. Fast track multi-discipline treatment (FTMDT trial versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Zhou Jiao-Jiao

    2011-11-01

    Full Text Available Abstract Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547

  9. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations

    Science.gov (United States)

    Yiadom, Maame Yaa A B; Domenico, Henry; Byrne, Daniel; Hasselblad, Michele Marie; Gatto, Cheryl L; Kripalani, Sunil; Choma, Neesha; Tucker, Sarah; Wang, Li; Bhatia, Monisha C; Morrison, Johnston; Harrell, Frank E; Hartert, Tina; Bernard, Gordon

    2018-01-01

    Introduction Hospital readmissions within 30 days are a healthcare quality problem associated with increased costs and poor health outcomes. Identifying interventions to improve patients’ successful transition from inpatient to outpatient care is a continued challenge. Methods and analysis This is a single-centre pragmatic randomised and controlled clinical trial examining the effectiveness of a discharge follow-up phone call to reduce 30-day inpatient readmissions. Our primary endpoint is inpatient readmission within 30 days of hospital discharge censored for death analysed with an intention-to-treat approach. Secondary endpoints included observation status readmission within 30 days, time to readmission, all-cause emergency department revisits within 30 days, patient satisfaction (measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems scores) and 30-day mortality. Exploratory endpoints include the need for assistance with discharge plan implementation among those randomised to the intervention arm and reached by the study nurse, and the number of call attempts to achieve successful intervention delivery. Consistent with the Learning Healthcare System model for clinical research, timeliness is a critical quality for studies to most effectively inform hospital clinical practice. We are challenged to apply pragmatic design elements in order to maintain a high-quality practicable study providing timely results. This type of prospective pragmatic trial empowers the advancement of hospital-wide evidence-based practice directly affecting patients. Ethics and dissemination Study results will inform the structure, objective and function of future iterations of the hospital’s discharge follow-up phone call programme and be submitted for publication in the literature. Trial registration number NCT03050918; Pre-results. PMID:29444787

  10. Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316

    Directory of Open Access Journals (Sweden)

    Kostense Piet J

    2009-06-01

    Full Text Available Abstract Background Many patients with type 2 diabetes (T2DM are not able to reach the glycaemic target level of HbA1c Methods/Design T2DM patients (n = 248, aged 35–75 years, with an HbA1c ≥ 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self-titrating insulin. The control group will receive usual care. Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle. Discussion An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy. Trial registration Dutch Trial Register TC1316.

  11. Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

    Science.gov (United States)

    Oyanguren, Juana; García-Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin-Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García-Gutiérrez, Susana

    2017-11-01

    Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of

  12. The clinical efficacy of reminiscence therapy in patients with mild-to-moderate Alzheimer disease: Study protocol for a randomized parallel-design controlled trial.

    Science.gov (United States)

    Li, Mo; Lyu, Ji-Hui; Zhang, Yi; Gao, Mao-Long; Li, Wen-Jie; Ma, Xin

    2017-12-01

    Alzheimer disease (AD) is one of the most common diseases among the older adults. Currently, various nonpharmacological interventions are used for the treatment of AD. Such as reminiscence therapy is being widely used in Western countries. However, it is often used as an empirical application in China; the evidence-based efficacy of reminiscence therapy in AD patients remains to be determined. Therefore, the aim of this research is to assess the effectives of reminiscence therapy for Chinese elderly. This is a randomized parallel-design controlled trial. Mild and moderate AD patients who are in the Beijing Geriatric Hospital, China will be randomized into control and intervention groups (n = 45 for each group). For the intervention group, along with conventional drug therapy, participants will be exposed to a reminiscence therapy of 35 to 45 minutes, 2 times/wk for 12 consecutive weeks. Patients in the control group will undergo conventional drug therapy only. The primary outcome measure will be the differences in Alzheimer disease Assessment Scale-Cognitive Section Score. The secondary outcome measures will be the differences in the Cornell scale for depression in dementia, Neuropsychiatric Inventory score, and Barthel Index scores at baseline, at 4 and 12 weeks of treatment, and 12 weeks after treatment. The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval no. 2015-010). Findings will be disseminated through presentation at scientific conferences and in academic journals. Chinese Clinical Trial Registry identifier ChiCTR-INR-16009505. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

  13. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: a randomised controlled trial--design, evaluation, recruitment issues.

    Science.gov (United States)

    Bröning, Sonja; Wiedow, Annika; Wartberg, Lutz; Ruths, Sylvia; Haevelmann, Andrea; Kindermann, Sally-Sophie; Moesgen, Diana; Schaunig-Busch, Ines; Klein, Michael; Thomasius, Rainer

    2012-03-22

    Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784).

  14. The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals.

    Science.gov (United States)

    Gärtner, Fania R; Ketelaar, Sarah M; Smeets, Odile; Bolier, Linda; Fischer, Eva; van Dijk, Frank J H; Nieuwenhuijsen, Karen; Sluiter, Judith K

    2011-05-10

    Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and

  15. Control room design

    International Nuclear Information System (INIS)

    Zinke, H.

    1980-01-01

    To control a 1300 megawatt nuclear power plant, about 15000 plant parameters must be collected together to control and operate the plant. The control room design therefore is of particular importance. The main design criteria are: Required functions of the power plant process - Level of Automation - Ergonomics - Available Technology. Extensive analysis has resulted in a control room design method. This ensures that an objective solution will be reached. Resulting from this methodical approach are: 1. Scope, position and appearance of the instrumentation. 2. Scope, position and appearance of the operator controls. Process analysis dictates what instrumentation and operator controls are needed. The priority and importance of the control and instrumentation (this we define as the utilisation areas), dictates the rough layout of the control room. (orig./RW)

  16. Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.

    Science.gov (United States)

    Middleton, Lee J; Daniels, Jane P; Weckesser, Annalise; Bhattacharya, Siladitya

    2017-03-11

    Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design

  17. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

    Science.gov (United States)

    Roulaud, M; Durand-Zaleski, I; Ingrand, P; Serrie, A; Diallo, B; Peruzzi, P; Hieu, P D; Voirin, J; Raoul, S; Page, P; Fontaine, D; Lantéri-Minet, M; Blond, S; Buisset, N; Cuny, E; Cadenne, M; Caire, F; Ranoux, D; Mertens, P; Naous, H; Simon, E; Emery, E; Gadan, B; Regis, J; Sol, J-C; Béraud, G; Debiais, F; Durand, G; Guetarni Ging, F; Prévost, A; Brandet, C; Monlezun, O; Delmotte, A; d'Houtaud, S; Bataille, B; Rigoard, P

    2015-03-01

    Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112

  18. Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial

    Directory of Open Access Journals (Sweden)

    Kostense Piet J

    2009-04-01

    Full Text Available Abstract Background Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM. Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy. Methods and design Six hundred patients with T2DM (45 ≤ 75 years who receive care in a structured diabetes care system, HbA1c ≥ 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG, Self-monitoring of Urine Glucose (SMUG and usual care (n = 200 per group. Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs. Discussion The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to

  19. Applied Control Systems Design

    CERN Document Server

    Mahmoud, Magdi S

    2012-01-01

    Applied Control System Design examines several methods for building up systems models based on real experimental data from typical industrial processes and incorporating system identification techniques. The text takes a comparative approach to the models derived in this way judging their suitability for use in different systems and under different operational circumstances. A broad spectrum of control methods including various forms of filtering, feedback and feedforward control is applied to the models and the guidelines derived from the closed-loop responses are then composed into a concrete self-tested recipe to serve as a check-list for industrial engineers or control designers. System identification and control design are given equal weight in model derivation and testing to reflect their equality of importance in the proper design and optimization of high-performance control systems. Readers’ assimilation of the material discussed is assisted by the provision of problems and examples. Most of these e...

  20. The effects of isolated ankle strengthening and functional balance training on strength, running mechanics, postural control and injury prevention in novice runners: design of a randomized controlled trial.

    Science.gov (United States)

    Baltich, Jennifer; Emery, Carolyn A; Stefanyshyn, Darren; Nigg, Benno M

    2014-12-04

    . Injuries rates will be compared between groups over 6 months. Avoiding injury will allow individuals to enjoy the benefits of participating in aerobic activities and reduce the healthcare costs associated with running injuries. Current Controlled Trial NCT01900262.

  1. Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

    Science.gov (United States)

    Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

    2013-01-01

    Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are

  2. Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nancy Kassam-Adams

    2013-07-01

    Full Text Available Background: Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives: To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method: Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification in the hospital and will be instructed on how to complete modules 2 (Appraisals and 3 (Avoidance online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results: Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life. Discussion: Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a

  3. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Science.gov (United States)

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  4. The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) randomized controlled trial: design and methods.

    Science.gov (United States)

    Landi, Francesco; Cesari, Matteo; Calvani, Riccardo; Cherubini, Antonio; Di Bari, Mauro; Bejuit, Raphael; Mshid, Jerome; Andrieu, Sandrine; Sinclair, Alan J; Sieber, Cornel C; Vellas, Bruno; Topinkova, Eva; Strandberg, Timo; Rodriguez-Manas, Leocadio; Lattanzio, Fabrizia; Pahor, Marco; Roubenoff, Ronenn; Cruz-Jentoft, Alfonso J; Bernabei, Roberto; Marzetti, Emanuele

    2017-02-01

    The sustainability of health and social care systems is threatened by a growing population of older persons with heterogeneous needs related to multimorbidity, frailty, and increased risk of functional impairment. Since disability is difficult to reverse in old age and is extremely burdensome for individuals and society, novel strategies should be devised to preserve adequate levels of function and independence in late life. The development of mobility disability, an early event in the disablement process, precedes and predicts more severe forms of inability. Its prevention is, therefore, critical to impede the transition to overt disability. For this reason, the Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies (SPRINTT) project is conducting a randomized controlled trial (RCT) to test a multicomponent intervention (MCI) specifically designed to prevent mobility disability in high-risk older persons. SPRINTT is a phase III, multicenter RCT aimed at comparing the efficacy of a MCI, based on long-term structured physical activity, nutritional counseling/dietary intervention, and an information and communication technology intervention, versus a healthy aging lifestyle education program designed to prevent mobility disability in 1500 older persons with physical frailty and sarcopenia who will be followed for up to 36 months. The primary outcome of the SPRINTT trial is mobility disability, operationalized as the inability to walk for 400 m within 15 min, without sitting, help of another person, or the use of a walker. Secondary outcomes include changes in muscle mass and strength, persistent mobility disability, falls and injurious falls, disability in activities of daily living, nutritional status, cognition, mood, the use of healthcare resources, cost-effectiveness analysis, quality of life, and mortality rate. SPRINTT results are expected to promote significant advancements in the management of frail older persons at high risk

  5. Large head metal-on-metal cementless total hip arthroplasty versus 28mm metal-on-polyethylene cementless total hip arthroplasty: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Raaij Jos JAM

    2008-10-01

    Superior results of large head metal-on-metal total hip arthroplasty over conventional hip arthroplasty have been put forward by experts, case series and the industry, but to our knowledge there is no randomized controlled evidence. Conclusion This randomized controlled study has been designed to test whether large head metal-on-metal cementless total hip arthroplasty leads to less periprosthetic bone density loss and higher serum metal ion concentrations compared to 28 mm metal-on-polyethylene cementless total hip arthroplasty. Trial registration Netherlands Trial Registry NTR1399

  6. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods.

    Science.gov (United States)

    Gillison, Fiona; Standage, Martyn; Verplanken, Bas

    2014-03-04

    Physical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme. A three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16-18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post

  7. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

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    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  8. Design of a randomized controlled trial for genomic carrier screening in healthy patients seeking preconception genetic testing

    OpenAIRE

    Kauffman, Tia L.; Wilfond, Benjamin S.; Jarvik, Gail P.; Leo, Michael C.; Lynch, Frances L.; Reiss, Jacob A.; Richards, C. Sue; McMullen, Carmit; Nickerson, Deborah; Dorschner, Michael O.; Goddard, Katrina A.B.

    2016-01-01

    Population-based carrier screening is limited to well-studied or high-impact genetic conditions for which the benefits may outweigh the associated harms and costs. As the cost of genome sequencing declines and availability increases, the balance of risks and benefits may change for a much larger number of genetic conditions, including medically actionable additional findings. We designed an RCT to evaluate genomic clinical sequencing for women and partners considering a pregnancy. All results...

  9. Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.

    Science.gov (United States)

    Moradian, Saeed; Walshe, Catherine; Shahidsales, Soodabeh; Ghavam Nasiri, Mohammad Reza; Pilling, Mark; Molassiotis, Alexander

    2015-06-01

    Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV. A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial. 99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06). Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anna-Carlotta Zarski

    2018-01-01

    Full Text Available IntroductionGenito-pelvic pain/penetration disorder (GPPPD not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.MethodTwo hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG or a 6-month waitlist control group. Assessments take place at baseline (T1, peritreatment after completion of Session 5 in IG (T2, after completion of Session 8 or 12 weeks after randomization (T3, and after 6 months (T4. Data will be analyzed on an intention-to-treat and a completer basis.Main outcome measuresThe primary outcome will be sexual intercourse involving the insertion of the partner’s penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1 and investigated as a potential moderator of the primary treatment outcome.DiscussionGiven the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.Clinical Trial RegistrationGerman Register of Clinical Studies (DRKS

  11. Minimally invasive computer-navigated total hip arthroplasty, following the concept of femur first and combined anteversion: design of a blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Woerner Michael

    2011-08-01

    Full Text Available Abstract Background Impingement can be a serious complication after total hip arthroplasty (THA, and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated. Methods/Design A registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements. Discussion In the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this

  12. Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial.

    Science.gov (United States)

    van der Heijden, Marion M P; Pouwer, François; Romeijnders, Arnold C; Pop, Victor J M

    2012-07-04

    Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account. This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands.Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control. We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing

  13. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

    Directory of Open Access Journals (Sweden)

    Johnson Jeffrey A

    2012-08-01

    Full Text Available Abstract Background When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting. Methods/design We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1 improving depressive symptoms, 2 improving blood glucose, blood pressure and cholesterol, and 3 improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled “on-off” trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol. Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all

  14. The (cost-effectiveness of an individually tailored long-term worksite health promotion programme on physical activity and nutrition: design of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Burdorf Alex

    2007-09-01

    Full Text Available Abstract Background Cardiovascular disease is the leading cause of disability and mortality in most Western countries. The prevalence of several risk factors, most notably low physical activity and poor nutrition, is very high. Therefore, lifestyle behaviour changes are of great importance. The worksite offers an efficient structure to reach large groups and to make use of a natural social network. This study investigates a worksite health promotion programme with individually tailored advice in physical activity and nutrition and individual counselling to increase compliance with lifestyle recommendations and sustainability of a healthy lifestyle. Methods/Design The study is a pragmatic cluster randomised controlled trial with the worksite as the unit of randomisation. All workers will receive a standard worksite health promotion program. Additionally, the intervention group will receive access to an individual Health Portal consisting of four critical features: a computer-tailored advice, a monitoring function, a personal coach, and opportunities to contact professionals at request. Participants are employees working for companies in the Netherlands, being literate enough to read and understand simple Internet-based messages in the Dutch language. A questionnaire to assess primary outcomes (compliance with national recommendations on physical activity and on fruit and vegetable intake will take place at baseline and after 12 and 24 months. This questionnaire also assesses secondary outcomes including fat intake, self-efficacy and self-perceived barriers on physical activity and fruit and vegetable intake. Other secondary outcomes, including a cardiovascular risk profile and physical fitness, will be measured at baseline and after 24 months. Apart from the effect evaluation, a process evaluation will be carried out to gain insight into participation and adherence to the worksite health promotion programme. A cost-effectiveness analysis and

  15. Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

    Science.gov (United States)

    Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

    2014-06-19

    Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice

  16. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  17. Study design for a randomised controlled trial to explore the modality and mechanism of Tai Chi in the pulmonary rehabilitation of chronic obstructive pulmonary disease.

    Science.gov (United States)

    Fu, Juan-Juan; Min, Jie; Yu, Peng-Ming; McDonald, Vanessa M; Mao, Bing

    2016-08-04

    Although pulmonary rehabilitation (PR) is associated with significant clinical benefits in chronic obstructive pulmonary disease (COPD) and has been recommended by guidelines, PR with conventional exercise training has not been widely applied in the clinic because of its inherent limitations. Alternative exercise such as Tai Chi has been investigated and the results are promising. However, the strengths and weaknesses of the exercise modality of Tai Chi, conventional PR and a combination of Tai Chi and conventional PR and the possible mechanisms underlying Tai Chi exercise remain unclear. This study aims to address the above research gaps in a well-designed clinical trial. This study is a single-blind, randomised controlled trial. Participants with stable COPD will be recruited and randomly assigned to one of four groups receiving Tai Chi exercise, conventional PR using a total body recumbent stepper (TBRS), combined Tai Chi and TBRS, or usual care (control) in a 1:1:1:1 ratio. Participants will perform 30 min of supervised exercise three times a week for 8 weeks; they will receive sequential follow-ups until 12 months after recruitment. The primary outcome will be health-related quality of life as measured by the St George's Respiratory Questionnaire. Secondary outcomes will include 6 min walking distance, pulmonary function, the modified Medical Research Council Dyspnoea Scale, the COPD Assessment Test, the Hospital Anxiety and Depression Scale, the Berg Balance Scale, exacerbation frequency during the study period, and systemic inflammatory and immune markers. Ethics approval has been granted by the Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University (No TCM-2015-82). Written informed consent will be obtained from each participant before any procedures are performed. The study findings will be published in peer-reviewed journals and presented at national and international conferences. ChiCTR-IOR-15006874; Pre

  18. Return to work of workers without a permanent employment contract, sick-listed due to a common mental disorder: design of a randomised controlled trial.

    Science.gov (United States)

    Lammerts, Lieke; Vermeulen, Sylvia J; Schaafsma, Frederieke G; van Mechelen, Willem; Anema, Johannes R

    2014-06-12

    Workers without a permanent employment contract represent a vulnerable group within the working population. Mental disorders are a major cause of sickness absence within this group. Common mental disorders are stress-related, depressive and anxiety disorders. To date, little attention has been paid to effective return to work interventions for this type of sick-listed workers. Therefore, a participatory supportive return to work program has been developed. It combines elements of a participatory return to work program, integrated care and direct placement in a competitive job.The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual. The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions, resulting in a consensus based action plan. This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency. During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.Workers eligible to participate in this study have no permanent employment contract, have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.The primary outcome measure is the duration until first sustainable return to work in a competitive job. Outcomes are measured at baseline and after three, six, nine and twelve months. If the participatory supportive return to work program proves to be cost-effective, the social security system, the sick-listed worker and society as a whole will benefit. A cost-effective return to work program will lead to a

  19. The TOPGAME-study: effectiveness of extracorporeal shockwave therapy in jumping athletes with patellar tendinopathy. Design of a randomised controlled trial

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    Diercks Ron L

    2010-02-01

    Full Text Available Abstract Background Patellar tendinopathy is a major problem for many athletes, especially those involved in jumping activities. Despite its frequency and negative impact on athletic careers, no evidence-based guidelines for management of this overuse injury exist. Since functional outcomes of conservative and surgical treatments remain suboptimal, new diagnostic and therapeutic strategies have to be developed and evaluated. Extracorporeal shockwave therapy (ESWT appears to be a promising treatment in patients with chronic patellar tendinopathy. ESWT is most often applied after the known conservative treatments have failed. However, its effectiveness as primary therapy has not been studied in athletes who keep playing sports despite having patellar tendon pain. The aim of this study is to determine the effectiveness of ESWT in athletes with patellar tendinopathy who are still in training and competition. Methods/design The TOPGAME-study (Tendinopathy of Patella Groningen Amsterdam Maastricht ESWT is a multicentre two-armed randomised controlled trial with blinded participants and outcome assessors, in which the effectiveness of patient-guided focussed ESWT treatment (compared to placebo ESWT on pain reduction and recovery of function in athletes with patellar tendinopathy will be investigated. Participants are volleyball, handball and basketball players with symptoms of patellar tendinopathy for a minimum of 3 to a maximum duration of 12 months who are still able to train and compete. The intervention group receives three patient-guided focussed medium-energy density ESWT treatments without local anaesthesia at a weekly interval in the first half of the competition. The control group receives placebo treatment. The follow-up measurements take place 1, 12 and 22 weeks after the final ESWT or placebo treatment, when athletes are still in competition. Primary outcome measure is the VISA-P (Victorian Institute of Sport Assessment - patella score

  20. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kaner Eileen FS

    2008-11-01

    Full Text Available Abstract Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC. It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores, whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the

  1. Control system design method

    Science.gov (United States)

    Wilson, David G [Tijeras, NM; Robinett, III, Rush D.

    2012-02-21

    A control system design method and concomitant control system comprising representing a physical apparatus to be controlled as a Hamiltonian system, determining elements of the Hamiltonian system representation which are power generators, power dissipators, and power storage devices, analyzing stability and performance of the Hamiltonian system based on the results of the determining step and determining necessary and sufficient conditions for stability of the Hamiltonian system, creating a stable control system based on the results of the analyzing step, and employing the resulting control system to control the physical apparatus.

  2. Community-based physical activity as adjunctive smoking cessation treatment: Rationale, design, and baseline data for the Lifestyle Enhancement Program (LEAP randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mark W. Vander Weg

    2018-03-01

    Full Text Available Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP, a two-group, randomized controlled trial. Adult smokers who engaged in low levels of leisure time physical activity were randomly assigned to treatment conditions consisting of an individualized physical activity intervention delivered by health fitness instructors in community-based exercise facilities or an equal contact wellness control. All participants received standard cognitive behavioral smoking cessation counseling combined with nicotine replacement therapy. The primary outcomes are seven-day point prevalence abstinence at seven weeks, six- and 12 months. Secondary outcomes include self-reported physical activity, dietary intake, body mass index, waist circumference, percent body fat, and nicotine withdrawal symptoms. Participants consist of 392 sedentary smokers (mean [standard deviation] age = 44.6 [10.2] = years; 62% female; 31% African American. Results reported here provide information regarding experiences recruiting smokers willing to change multiple health behaviors including smoking and physical activity.

  3. Design of a randomized controlled trial for genomic carrier screening in healthy patients seeking preconception genetic testing.

    Science.gov (United States)

    Kauffman, Tia L; Wilfond, Benjamin S; Jarvik, Gail P; Leo, Michael C; Lynch, Frances L; Reiss, Jacob A; Richards, C Sue; McMullen, Carmit; Nickerson, Deborah; Dorschner, Michael O; Goddard, Katrina A B

    2017-02-01

    Population-based carrier screening is limited to well-studied or high-impact genetic conditions for which the benefits may outweigh the associated harms and costs. As the cost of genome sequencing declines and availability increases, the balance of risks and benefits may change for a much larger number of genetic conditions, including medically actionable additional findings. We designed an RCT to evaluate genomic clinical sequencing for women and partners considering a pregnancy. All results are placed into the medical record for use by healthcare providers. Through quantitative and qualitative measures, including baseline and post result disclosure surveys, post result disclosure interviews, 1-2year follow-up interviews, and team journaling, we are obtaining data about the clinical and personal utility of genomic carrier screening in this population. Key outcomes include the number of reportable carrier and additional findings, and the comparative cost, utilization, and psychosocial impacts of usual care vs. genomic carrier screening. As the study progresses, we will compare the costs of genome sequencing and usual care as well as the cost of screening, pattern of use of genetic or mental health counseling services, number of outpatient visits, and total healthcare costs. This project includes novel investigation into human reactions and responses from would-be parents who are learning information that could both affect a future pregnancy and their own health. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  4. Rationale and design of the HEALTHY-CATH trial: A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of Catheter Associated infecTion in Haemodialysis patients

    Directory of Open Access Journals (Sweden)

    Broom Jennifer K

    2009-08-01

    Full Text Available Abstract Background Catheter-related bacteraemias (CRBs contribute significantly to morbidity, mortality and health care costs in dialysis populations. Despite international guidelines recommending avoidance of catheters for haemodialysis access, hospital admissions for CRBs have doubled in the last decade. The primary aim of the study is to determine whether weekly instillation of 70% ethanol prevents CRBs compared with standard heparin saline. Methods/design The study will follow a prospective, open-label, randomized controlled design. Inclusion criteria are adult patients with incident or prevalent tunneled intravenous dialysis catheters on three times weekly haemodialysis, with no current evidence of catheter infection and no personal, cultural or religious objection to ethanol use, who are on adequate contraception and are able to give informed consent. Patients will be randomized 1:1 to receive 3 mL of intravenous-grade 70% ethanol into each lumen of the catheter once a week and standard heparin locks for other dialysis days, or to receive heparin locks only. The primary outcome measure will be time to the first episode of CRB, which will be defined using standard objective criteria. Secondary outcomes will include adverse reactions, incidence of CRB caused by different pathogens, time to infection-related catheter removal, time to exit site infections and costs. Prospective power calculations indicate that the study will have 80% statistical power to detect a clinically significant increase in median infection-free survival from 200 days to 400 days if 56 patients are recruited into each arm. Discussion This investigator-initiated study has been designed to provide evidence to help nephrologists reduce the incidence of CRBs in haemodialysis patients with tunnelled intravenous catheters. Trial Registration Australian New Zealand Clinical Trials Registry Number: ACTRN12609000493246

  5. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability.

    Science.gov (United States)

    Bartels, Ronald H M A; Hosman, Allard J F; van de Meent, Henk; Hofmeijer, Jeannette; Vos, Pieter E; Slooff, Willem Bart; Öner, F Cumhur; Coppes, Maarten H; Peul, Wilco C; Verbeek, André L M

    2013-01-31

    Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care), duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Gov: NCT01367405.

  6. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

    Science.gov (United States)

    Vonk Noordegraaf, Antonie; Huirne, Judith A F; Brölmann, Hans A M; Emanuel, Mark H; van Kesteren, Paul J M; Kleiverda, Gunilla; Lips, Jos P; Mozes, Alexander; Thurkow, Andreas L; van Mechelen, Willem; Anema, Johannes R

    2012-02-01

    Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Netherlands Trial Register (NTR): NTR2087.

  7. Mindful "Vitality in Practice": an intervention to improve the work engagement and energy balance among workers; the development and design of the randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Boot Cécile RL

    2011-09-01

    Full Text Available Abstract Background Modern working life has become more mental and less physical in nature, contributing to impaired mental health and a disturbed energy balance. This may result in mental health problems and overweight. Both are significant threats to the health of workers and thus also a financial burden for society, including employers. Targeting work engagement and energy balance could prevent impaired mental health and overweight, respectively. Methods/Design The study population consists of highly educated workers in two Dutch research institutes. The intervention was systematically developed, based on the Intervention Mapping (IM protocol, involving workers and management in the process. The workers' needs were assessed by combining the results of interviews, focus group discussions and a questionnaire with available literature. Suitable methods and strategies were selected resulting in an intervention including: eight weeks of customized mindfulness training, followed by eight sessions of e-coaching and supporting elements, such as providing fruit and snack vegetables at the workplace, lunch walking routes, and a buddy system. The effects of the intervention will be evaluated in a RCT, with measurements at baseline, six months (T1 and 12 months (T2. In addition, cost-effectiveness and process of the intervention will also be evaluated. Discussion At baseline the level of work engagement of the sample was "average". Of the study population, 60.1% did not engage in vigorous physical activity at all. An average working day consists of eight sedentary hours. For the Phase II RCT, there were no significant differences between the intervention and the control group at baseline, except for vigorous physical activity. The baseline characteristics of the study population were congruent with the results of the needs assessment. The IM protocol used for the systematic development of the intervention produced an appropriate intervention to test in

  8. Mindful "Vitality in Practice": an intervention to improve the work engagement and energy balance among workers; the development and design of the randomised controlled trial

    Science.gov (United States)

    2011-01-01

    Background Modern working life has become more mental and less physical in nature, contributing to impaired mental health and a disturbed energy balance. This may result in mental health problems and overweight. Both are significant threats to the health of workers and thus also a financial burden for society, including employers. Targeting work engagement and energy balance could prevent impaired mental health and overweight, respectively. Methods/Design The study population consists of highly educated workers in two Dutch research institutes. The intervention was systematically developed, based on the Intervention Mapping (IM) protocol, involving workers and management in the process. The workers' needs were assessed by combining the results of interviews, focus group discussions and a questionnaire with available literature. Suitable methods and strategies were selected resulting in an intervention including: eight weeks of customized mindfulness training, followed by eight sessions of e-coaching and supporting elements, such as providing fruit and snack vegetables at the workplace, lunch walking routes, and a buddy system. The effects of the intervention will be evaluated in a RCT, with measurements at baseline, six months (T1) and 12 months (T2). In addition, cost-effectiveness and process of the intervention will also be evaluated. Discussion At baseline the level of work engagement of the sample was "average". Of the study population, 60.1% did not engage in vigorous physical activity at all. An average working day consists of eight sedentary hours. For the Phase II RCT, there were no significant differences between the intervention and the control group at baseline, except for vigorous physical activity. The baseline characteristics of the study population were congruent with the results of the needs assessment. The IM protocol used for the systematic development of the intervention produced an appropriate intervention to test in the planned RCT. Trial

  9. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial.

    Science.gov (United States)

    Niederer, Iris; Kriemler, Susi; Zahner, Lukas; Bürgi, Flavia; Ebenegger, Vincent; Hartmann, Tim; Meyer, Ursina; Schindler, Christian; Nydegger, Andreas; Marques-Vidal, Pedro; Puder, Jardena J

    2009-03-31

    ), attention and spatial working memory ability (two validated tests). Researchers were blinded to group allocation. The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration: (clinicaltrials.gov) NCT00674544.

  10. Decrease social inequalities return-to-work: development and design of a randomised controlled trial among women with breast cancer.

    Science.gov (United States)

    Vidor, Clémence; Leroyer, Ariane; Christophe, Véronique; Seillier, Mélanie; Foncel, Jérome; Van de Maële, Justine; Bonneterre, Jacques; Fantoni, Sophie

    2014-04-17

    Despite the improvement in the care management, women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment. Their return-to-work probability is impacted by numerous psychosocial factors. The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support (APAPI). The intervention proposed is made up of 4 interviews with a psychologist at the hospital, distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation, then a consultation with a specialist job retention physician. We expect, in the first instance, that this intervention will reduce the social inequalities of the return-to-work rate at 12 months. The EPICES score will enable the population to be broken down according to the level of social precariousness. The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients. This intervention is assessed in the context of a controlled and randomised multi-centre study. The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively, having received surgery followed by adjuvant chemotherapy, in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres. It is essential to assess this type of intervention before envisaging its generalisation. The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients, in particular for those who suffer from social fragility, compared with the standard care.

  11. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

    Science.gov (United States)

    Wright, Julie A; Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

    2014-11-10

    Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405

  12. The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

    Science.gov (United States)

    Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

    2018-03-01

    Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

  13. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial.

    Science.gov (United States)

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2013-01-23

    Pain affects quality of life and can result in absence from work. Treatment and/or prevention strategies for musculoskeletal pain-related long-term sick leave are currently undertaken in several health sectors. Moreover, there are few evidence-based guidelines for such treatment and prevention. The aim of this study is to evaluate the efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' for sick-listed citizens with pain in the back and/or the upper body. This protocol describes the design of a parallel randomised controlled trial on the efficacy of 'Tailored Physical Activity' or a 'Chronic Pain Self-management Program' versus a reference group for sick-listed citizens with complaints of pain in the back or upper body. Participants will have been absent from work due to sick-listing for 3 to 9 weeks at the time of recruitment. All interventions will be performed at the 'Health Care Center' in the Sonderborg Municipality, and a minimum of 138 participants will be randomised into one of the three groups.All participants will receive 'Health Guidance', a (1.5-hour) individualised dialogue focusing on improving ways of living, based on assessments of risk behavior, motivation for change, level of self-care and personal resources. In addition, the experimental groups will receive either 'Tailored Physical Activity' (three 50-minute sessions/week over 10 weeks) or 'Chronic Pain Self-Management Program' (2.5-hours per week over 6 weeks). The reference group will receive only 'Health Guidance'.The primary outcome is the participants' sick-listed status at 3 and 12 months after baseline. The co-primary outcome is the time it takes to return to work. In addition, secondary outcomes include anthropometric measurements, functional capacity and self-reported number of sick days, musculoskeletal symptoms, general health, work ability, physical capacity, kinesiophobia, physical functional status, interpersonal problems and mental disorders. There

  14. Cost-effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for nonspecific low back pain: design of a stepped-wedge cluster randomised controlled trial.

    Science.gov (United States)

    Suman, Arnela; Schaafsma, Frederieke G; Elders, Petra J M; van Tulder, Maurits W; Anema, Johannes R

    2015-05-31

    Low back pain (LBP) is one of the most prevalent and expensive health care problems in industrialised countries. LBP leads to high health care utility and productivity losses; leaving the individual, the employer, and society with substantial costs. To improve the care for LBP patients and reduce the high societal and financial burden of LBP, in 2010 the 'Multidisciplinary care guideline for nonspecific low back pain' was developed in the Netherlands. The current paper describes the design of a study aiming to evaluate the (cost-) effectiveness of a multifaceted strategy to implement this guideline. In a cluster-randomised controlled trial, the (cost-) effectiveness of a multifaceted implementation strategy will be compared to passive guideline dissemination. Using a stepped-wedge approach, participating general practitioners, physiotherapists, and occupational physicians are allocated into clusters and will attend a multidisciplinary continuing medical education training session. The timing these clusters receive the training is the unit of randomisation. LBP patients visiting the participating health care providers are invited to participate in the trial and will receive access to a multimedia intervention aimed at improving beliefs, cognitions, and self-management. The primary outcome measure of this study is patient back beliefs. Secondary outcome measures on patient level include pain, functional status, quality of life, health care utility, and productivity losses. Outcome measures on professional level include knowledge and attitude towards the guideline, and guideline adherence. A process evaluation for the implementation strategy will be performed among the health care providers and the patients. Furthermore, a qualitative subgroup analysis among patients with various ethnic backgrounds will be performed. This study will give insight into the (cost-) effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for non

  15. Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

    Directory of Open Access Journals (Sweden)

    St George Bridget

    2011-07-01

    Full Text Available Abstract Background Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. Methods After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. Results We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures

  16. 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

  17. Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda.

    Science.gov (United States)

    Nagel, Corey L; Kirby, Miles A; Zambrano, Laura D; Rosa, Ghislane; Barstow, Christina K; Thomas, Evan A; Clasen, Thomas F

    2016-12-15

    In Rwanda, pneumonia and diarrhea are the first and second leading causes of death, respectively, among children under five. Household air pollution (HAP) resultant from cooking indoors with biomass fuels on traditional stoves is a significant risk factor for pneumonia, while consumption of contaminated drinking water is a primary cause of diarrheal disease. To date, there have been no large-scale effectiveness trials of programmatic efforts to provide either improved cookstoves or household water filters at scale in a low-income country. In this paper we describe the design of a cluster-randomized trial to evaluate the impact of a national-level program to distribute and promote the use of improved cookstoves and advanced water filters to the poorest quarter of households in Rwanda. We randomly allocated 72 sectors (administratively defined units) in Western Province to the intervention, with the remaining 24 sectors in the province serving as controls. In the intervention sectors, roughly 100,000 households received improved cookstoves and household water filters through a government-sponsored program targeting the poorest quarter of households nationally. The primary outcome measures are the incidence of acute respiratory infection (ARI) and diarrhea among children under five years of age. Over a one-year surveillance period, all cases of acute respiratory infection (ARI) and diarrhea identified by health workers in the study area will be extracted from records maintained at health facilities and by community health workers (CHW). In addition, we are conducting intensive, longitudinal data collection among a random sample of households in the study area for in-depth assessment of coverage, use, environmental exposures, and additional health measures. Although previous research has examined the impact of providing household water treatment and improved cookstoves on child health, there have been no studies of national-level programs to deliver these interventions

  18. A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial.

    Science.gov (United States)

    Zhu, Youwei; Jiang, Haifeng; Su, Hang; Zhong, Na; Li, Runji; Li, Xiaotong; Chen, Tianzhen; Tan, Haoye; Du, Jiang; Xu, Ding; Yan, Huan; Xu, Dawen; Zhao, Min

    2018-06-20

    Cognitive rehabilitation therapy has been found to improve cognitive deficits and impulse control problems in methamphetamine use disorder (MUD). However, there is limited research regarding this therapy's feasibility when using mobile-based health technologies in supporting recovery from MUD in China. The main aim of this study was to test whether 4 weeks of a newly designed computerized cognitive addiction therapy (CCAT) app can improve cognitive impairments, eliminate drug-related attention bias, and attenuate risk decision-making behaviors in participants with MUD. Forty MUD participants were assigned randomly to either the CCAT group (n=20), who received 4 weeks of CCAT plus regular detoxification treatment as usual, or the control group (n=20), who only received the regular detoxification treatment as usual, in drug rehabilitation centers in Shanghai. The CCAT was designed by combine methamphetamine use-related picture stimuli with cognitive training with the aim of improving cognitive function and eliminating drug-related attention bias. The CogState Battery, Delay Discounting Task (DDT), Iowa Gambling Task (IGT), and Balloon Analog Risk Task (BART) were administered face-to-face to all participants before and after CCAT interventions. Forty male patients were recruited. The mean age was 32.70 (SD 5.27) years in the CCAT group and mean 35.05 (SD 8.02) years in the control group. Compared to the control group, CCAT improved working memory in the CCAT group (P=.01). Group×time interactions were observed among DDT, IGT, and BART tasks, with rates of discounting delayed rewards, IGT, and BART scores (Pcognitive impairment and impulsive control in MUD. Further study is needed to understand the underlying brain mechanisms of the cognitive therapy. ClinicalTrials.gov NCT03318081; https://clinicaltrials.gov/ct2/show/NCT03318081 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT03318081). ©Youwei Zhu, Haifeng Jiang, Hang Su, Na Zhong, Runji Li

  19. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2009-06-01

    Full Text Available Abstract Background Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD. The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. Methods and design In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. Discussion A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in

  20. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT

    Directory of Open Access Journals (Sweden)

    van Assen Luite

    2010-01-01

    Full Text Available Abstract Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum till one year (maximum will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy, also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE and functional status (Neck Disability Index (NDI-DV. Secondary outcomes are neck pain (Numeric Rating Scale (NRS, Eurocol, costs and quality of life (SF36. Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843

  1. Rationale and design of the oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets trial for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial

    Directory of Open Access Journals (Sweden)

    Isbel Nicole M

    2009-07-01

    Full Text Available Abstract Background The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin® ES administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA-treated peritoneal dialysis (PD patients than conventional oral iron supplementation (Ferrogradumet®. Methods Inclusion criteria are peritoneal dialysis patients treated with darbepoietin alpha (DPO; Aranesp®, Amgen for ≥ 1 month. Patients will be randomized 1:1 to receive either slow-release ferrous sulphate (1 tablet twice daily; control or HIP (1 tablet twice daily for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During the 6-month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements will be performed bi-monthly. The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance (ANCOVA. Secondary outcome measures will include serum ferritin concentration, haemoglobin level, DPO dosage, Key's index (DPO dosage divided by haemoglobin concentration, and occurrence of adverse events (especially gastrointestinal adverse events. Discussion This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their peritoneal dialysis patients determine whether HIP administration more effectively augments iron stores in ESP-treated PD patients than conventional oral iron supplementation. Trial Registration Australia New Zealand Clinical Trials Registry number ACTRN12609000432213.

  2. Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

    Directory of Open Access Journals (Sweden)

    Graham Laura

    2008-10-01

    Full Text Available Abstract Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group or upper limb therapy alone (control group. Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT. Secondary outcomes include: spasticity (Modified Ashworth Scale; grip strength; dexterity (Nine Hole Peg Test; disability (Barthel Activities of Daily Living Index; quality of life (Stroke Impact Scale, Euroqol EQ-5D and attainment of patient-selected goals (Canadian Occupational Performance Measure. Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment

  3. Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560

    NARCIS (Netherlands)

    Steenstra, I.A.; Anema, J.R.; Bongers, P.M.; Vet, H.C.W. de; Mechelen, W. van

    2003-01-01

    Background: To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2-8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back

  4. Design of the FINS-TEENS study: A randomized controlled trial assessing the impact of fatty fish on cognitive performance in adolescents.

    Science.gov (United States)

    Skotheim, Siv; Dahl, Lisbeth; Handeland, Katina; Frøyland, Livar; Lie, Øyvind; Øyen, Jannike; Kjellevold, Marian; Stormark, Kjell Morten; Graff, Ingvild Eide

    2017-08-01

    To describe the rationale, study design, population and dietary compliance in a randomized controlled trial (RCT) investigating the effect of fatty fish on cognitive performance and mental health in adolescents. In the Fish Intervention Studies-TEENS (FINS-TEENS) study we individually randomized 478 adolescents (14-15-year-olds) from eight secondary schools in Norway to receive school meal lunches with fatty fish or meat or n-3 supplements three times a week for 12 weeks. Demographic factors, psychological tests and biological measures were collected pre-and post-intervention. Duplicate portions of lunch meals were collected and individual intake recorded throughout the study. In total, 481 out of 785 adolescents (61%) agreed to participate and 34 (7%) dropped out. Breakfast consumption was the only group difference in background characteristics. Analyses of selected nutrients in the lunch meals showed higher levels of n-3 fatty acids, vitamin D and n-6 fatty acids in the fish compared to the meat meals. Dietary compliance (score 0-144) revealed that the intake in the Fish group (mean = 59, standard deviation (SD) = 35) were lower than in the Meat group (mean = 83, SD = 31, p school-based setting. The results also emphasize the importance of collecting detailed records of dietary compliance, as this information is important when interpreting and analysing the outcome of dietary interventions.

  5. A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

    Science.gov (United States)

    Meltzer, Lauren R; Simmons, Vani N; Sutton, Steven K; Drobes, David J; Quinn, Gwendolyn P; Meade, Cathy D; Unrod, Marina; Brandon, Karen O; Harrell, Paul T; Eissenberg, Thomas; Bullen, Christopher R; Brandon, Thomas H

    2017-09-01

    Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour.

    Science.gov (United States)

    Silarova, Barbora; Lucas, Joanne; Butterworth, Adam S; Di Angelantonio, Emanuele; Girling, Christine; Lawrence, Kathryn; Mackintosh, Stuart; Moore, Carmel; Payne, Rupert A; Sharp, Stephen J; Shefer, Guy; Tolkien, Zoe; Usher-Smith, Juliet; Walker, Matthew; Danesh, John; Griffin, Simon

    2015-09-07

    Cardiovascular disease (CVD) remains the leading cause of death globally. Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions. An integral part of this approach is the use of CVD risk scores. Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies. We aim to evaluate short-term effects of providing different types of information about coronary heart disease (CHD) risk, alongside lifestyle advice, on health-related behaviours. In a parallel-group, open randomised trial, we are allocating 932 male and female blood donors with no previous history of CVD aged 40-84 years in England to either no intervention (control group) or to one of three active intervention groups: i) lifestyle advice only; ii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics; and iii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics. The primary outcome is change in objectively measured physical activity. Secondary outcomes include: objectively measured dietary behaviours; cardiovascular risk factors; current medication and healthcare usage; perceived risk; cognitive evaluation of provision of CHD risk scores; and psychological outcomes. The follow-up assessment takes place 12 weeks after randomisation. The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups. The INFORM study has been designed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours. Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.

  7. Effectiveness and cost-effectiveness of an internet intervention for family caregivers of people with dementia: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Blom Marco M

    2013-01-01

    Full Text Available Abstract Background The number of people with dementia is rising rapidly as a consequence of the greying of the world population. There is an urgent need to develop cost effective approaches that meet the needs of people with dementia and their family caregivers. Depression, feelings of burden and caregiver stress are common and serious health problems in these family caregivers. Different kinds of interventions are developed to prevent or reduce the negative psychological consequences of caregiving. The use of internet interventions is still very limited, although they may be a cost effective way to support family caregivers in an earlier stage and diminish their psychological distress in the short and longer run. Methods/design A pragmatic randomized controlled trial is designed to evaluate the effectiveness and cost-effectiveness of ‘Mastery over Dementia’, an internet intervention for caregivers of people with dementia. The intervention aims at prevention and decrease of psychological distress, in particular depressive symptoms. The experimental condition consists of an internet course with 8 sessions and a booster session over a maximum period of 6 months guided by a psychologist. Caregivers in the comparison condition receive a minimal intervention. In addition to a pre and post measurement, an intermediate measurement will be conducted. In addition, there will be two follow-up measurements 3 and 6 months after post-treatment in the experimental group only. To study the effectiveness of the intervention, depressive symptoms are used as the primary outcome, whereas symptoms of anxiety, role overload and caregiver perceived stress are used as secondary outcomes. To study which caregivers profit most of the internet intervention, several variables that may modify the impact of the intervention are taken into account. Regarding the cost-effectiveness, an economic evaluation will be conducted from a societal perspective. Discussion This

  8. SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial.

    Science.gov (United States)

    Starr, Kathryn; McPherson, Gladys; Forrest, Mark; Cotton, Seonaidh C

    2015-07-08

    Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder. This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point. Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder. SMS text pre

  9. Implications of Clinical Trial Design on Sample Size Requirements

    OpenAIRE

    Leon, Andrew C.

    2008-01-01

    The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two par...

  10. Design of a randomized-controlled trial on low-intensity aerobic wheelchair exercise for inactive persons with chronic spinal cord injury

    NARCIS (Netherlands)

    van der Scheer, Jan W.; de Groot, Sonja; Postema, Klaas; Veeger, DirkJan H. E. J.; van der Woude, Lucas H. V.

    Purpose: To investigate effects and working mechanisms of low-intensity aerobic wheelchair exercise on fitness, (upper-body) health and active lifestyle in inactive persons with chronic spinal cord injury (SCI). Methods: A multicenter randomized-controlled trial (RCT) in 40 inactive manual

  11. Rotterdam Aphasia Therapy Study (RATS) - 3: " The efficacy of intensive cognitive-linguistic therapy in the acute stage of aphasia"; design of a randomised controlled trial

    NARCIS (Netherlands)

    F. Nouwens (Femke); D.W.J. Dippel (Diederik); M. Jong-Hagelstein (Marjolein); E.G. Visch-Brink (Evy); P.J. Koudstaal (Peter Jan); L. de Lau (Lonneke)

    2013-01-01

    textabstractBackground: Aphasia is a severely disabling condition occurring in 20 to 25% of stroke patients. Most patients with aphasia due to stroke receive speech and language therapy. Methodologically sound randomised controlled trials investigating the effect of specific interventions for

  12. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Glastonbury Briony

    2008-08-01

    Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

  13. Clustered randomised controlled trial of two education interventions designed to increase physical activity and well-being of secondary school students: the MOVE Project.

    Science.gov (United States)

    Tymms, Peter B; Curtis, Sarah E; Routen, Ash C; Thomson, Katie H; Bolden, David S; Bock, Susan; Dunn, Christine E; Cooper, Ashley R; Elliott, Julian G; Moore, Helen J; Summerbell, Carolyn D; Tiffin, Paul A; Kasim, Adetayo S

    2016-01-06

    To assess the effectiveness of 2 interventions in improving the physical activity and well-being of secondary school children. A clustered randomised controlled trial; classes, 1 per school, were assigned to 1 of 3 intervention arms or a control group based on a 2×2 factorial design. The interventions were peer-mentoring and participative learning. Year 7 children (aged 11-12) in the peer-mentoring intervention were paired with year 9 children for 6 weekly mentoring meetings. Year 7 children in the participative learning arm took part in 6 weekly geography lessons using personalised physical activity and Global Positioning System (GPS) data. Year 7 children in the combined intervention received both interventions, with the year 9 children only participating in the mentoring sessions. 1494 year 7 students from 60 schools in the North of England took part in the trial. Of these, 43 students opted out of taking part in the evaluation measurements, 2 moved teaching group and 58 changed school. Valid accelerometry outcome data were collected for 892 students from 53 schools; and well-being outcome data were available for 927 students from 52 schools. The primary outcomes were mean minutes of accelerometer-measured moderate-to-vigorous intensity physical activity per day, and well-being as evaluated by the KIDSCREEN-27 questionnaire. These data were collected 6 weeks after the intervention; a 12-month follow-up is planned. No significant effects (main or interaction) were observed for the outcomes. However, small positive differences were found for both outcomes for the participative learning intervention. These findings suggest that the 2 school-based interventions did not modify levels of physical activity or well-being within the period monitored. Change in physical activity may require more comprehensive individual behavioural intervention, and/or more system-based efforts to address wider environmental influences such as family, peers, physical environment

  14. Randomized controlled trial to evaluate the effect of canola oil on blood vessel function in peripheral arterial disease: rationale and design of the Canola-PAD Study

    Directory of Open Access Journals (Sweden)

    Enns JE

    2014-10-01

    Full Text Available Jennifer E Enns,1,2 Peter Zahradka,1–3 Randolph P Guzman,4,5 Alanna Baldwin,1 Brendon Foot,1 Carla G Taylor1–31Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Research Centre, Winnipeg, Canada; 2Department of Physiology, University of Manitoba, Winnipeg, Manitoba, Canada; 3Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada; 4IH Asper Clinical Research Institute, St Boniface Hospital, Winnipeg, Canada; 5Section of Vascular Surgery, Department of Surgery, St Boniface Hospital, Winnipeg, CanadaBackground: Individuals with peripheral arterial disease (PAD are at high risk for cardiac events due to atherosclerosis. Dietary fatty acid composition has been shown to modulate blood vessel properties, but whether a diet enriched in conventional canola oil can improve clinical endpoints in PAD is not known.Purpose: To describe the rationale and design of a clinical trial testing the effect of canola oil consumption on vascular function and cardiovascular risk factors in an 8-week dietary intervention in individuals with PAD.Methods: The Canola-PAD Study was a single center, prospective, double-blind, randomized controlled trial in 50 patients over 40 years old with PAD. Participants were randomized into two groups and consumed food items containing either conventional canola oil (25 g/day or an oil mixture representing the Western diet (25 g/day for 8 weeks as part of their usual diet. The primary outcome was vascular function (ankle-brachial index, arterial stiffness, endothelial dysfunction, walking capacity, and cognitive function. Secondary measurements included anthropometrics, serum lipid profile and fatty acid composition, markers of inflammation and glycemic control, and serum metabolite profile.Discussion: The Canola-PAD Study uses an innovative and noninvasive approach to evaluate the effect of canola oil on clinically relevant outcomes in individuals with PAD, including

  15. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  16. Making healthy eating and physical activity policy practice: the design and overview of a group randomized controlled trial in afterschool programs.

    Science.gov (United States)

    Beets, Michael W; Glenn Weaver, R; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S; Freedman, Darcy A; Saunders, Ruth; Pate, Russell R; Beighle, Aaron; Hutto, Brent; Moore, Justin B

    2014-07-01

    National and state organizations have developed policies calling upon afterschool programs (ASPs, 3-6 pm) to serve a fruit or vegetable (FV) each day for snack, while eliminating foods and beverages high in added-sugars, and to ensure children accumulate a minimum of 30 min/d of moderate-to-vigorous physical activity (MVPA). Few efficacious and cost-effective strategies exist to assist ASP providers in achieving these important public health goals. This paper reports on the design and conceptual framework of Making Healthy Eating and Physical Activity (HEPA) Policy Practice in ASPs, a 3-year group randomized controlled trial testing the effectiveness of strategies designed to improve snacks served and increase MVPA in children attending community-based ASPs. Twenty ASPs, serving over 1800 children (6-12 years) will be enrolled and match-paired based on enrollment size, average daily min/d MVPA, and days/week FV served, with ASPs randomized after baseline data collection to immediate intervention or a 1-year delayed group. The framework employed, STEPs (Strategies To Enhance Practice), focuses on intentional programming of HEPA in each ASPs' daily schedule, and includes a grocery store partnership to reduce price barriers to purchasing FV, professional development training to promote physical activity to develop core physical activity competencies, as well as ongoing technical support/assistance. Primary outcome measures include children's accelerometry-derived MVPA and time spend sedentary while attending an ASP, direct observation of staff HEPA promoting and inhibiting behaviors, types of snacks served, and child consumption of snacks, as well as, cost of snacks via receipts and detailed accounting of intervention delivery costs to estimate cost-effectiveness. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Making Healthy Eating and Physical Activity Policy Practice: The Design and Overview of a Group Randomized Controlled Trial in Afterschool Programs

    Science.gov (United States)

    Beets, Michael W.; Weaver, R. Glenn; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S.; Freedman, Darcy A.; Saunders, Ruth; Pate, Russell R.; Beighle, Aaron; Moore, Justin B.

    2014-01-01

    National and state organizations have developed policies calling upon afterschool programs (ASPs, 3-6pm) to serve a fruit or vegetable (FV) each day for snack, while eliminating foods and beverages high in added-sugars, and to ensure children accumulate a minimum of 30 min/d of moderate-to-vigorous physical activity (MVPA). Few efficacious and cost-effective strategies exist to assist ASP providers in achieving these important public health goals. This paper reports on the design and conceptual framework of Making Healthy Eating and Physical Activity (HEPA) Policy Practice in ASPs, a 3-year group randomized controlled trial testing the effectiveness of strategies designed to improve snacks served and increase MVPA in children attending community-based ASPs. Twenty ASPs, serving over 1,800 children (6-12yrs) will be enrolled and match-paired based on enrollment size, average daily min/d MVPA, and days/week FV served, with ASPs randomized after baseline data collection to immediate intervention or a 1-year delayed group. The framework employed, STEPs (Strategies To Enhance Practice), focuses on intentional programming of HEPA in each ASPs’ daily schedule, and includes a grocery store partnership to reduce price barriers to purchasing FV, professional development training to promote physical activity to develop core physical activity competencies, as well as ongoing technical support/assistance. Primary outcome measures include children’s accelerometry-derived MVPA and time spend sedentary while attending an ASP, direct observation of staff HEPA promoting and inhibiting behaviors, types of snacks served, and child consumption of snacks, as well as, cost of snacks via receipts and detailed accounting of intervention delivery costs to estimate cost-effectiveness. PMID:24893225

  18. Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

    Science.gov (United States)

    Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

    2015-01-01

    Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

  19. Design and usability evaluation of user-centered and visual-based aids for dietary food measurement on mobile devices in a randomized controlled trial.

    Science.gov (United States)

    Liu, Ying-Chieh; Chen, Chien-Hung; Lee, Chien-Wei; Lin, Yu-Sheng; Chen, Hsin-Yun; Yeh, Jou-Yin; Chiu, Sherry Yueh-Hsia

    2016-12-01

    We designed and developed two interactive apps interfaces for dietary food measurements on mobile devices. The user-centered designs of both the IPI (interactive photo interface) and the SBI (sketching-based interface) were evaluated. Four types of outcomes were assessed to evaluate the usability of mobile devices for dietary measurements, including accuracy, absolute weight differences, and the response time to determine the efficacy of food measurements. The IPI presented users with images of pre-determined portion sizes of a specific food and allowed users to scan and then select the most representative image matching the food that they were measuring. The SBI required users to relate the food shape to a readily available comparator (e.g., credit card) and scribble to shade in the appropriate area. A randomized controlled trial was conducted to evaluate their usability. A total of 108 participants were randomly assigned into the following three groups: the IPI (n=36) and SBI (n=38) experimental groups and the traditional life-size photo (TLP) group as the control. A total of 18 types of food items with 3-4 different weights were randomly selected for assessment by each type. The independent Chi-square test and t-test were performed for the dichotomous and continuous variable analyses, respectively. The total accuracy rates were 66.98%, 44.15%, and 72.06% for the IPI, SBI, and TLP, respectively. No significant difference was observed between the IPI and TLP, regardless of the accuracy proportion or weight differences. The SBI accuracy rates were significantly lower than the IPI and TLP accuracy rates, especially for several spooned, square cube, and sliced pie food items. The time needed to complete the operation assessment by the user was significantly lower for the IPI than for the SBI. Our study corroborates that the user-centered visual-based design of the IPI on a mobile device is comparable the TLP in terms of the usability for dietary food measurements

  20. A Patient Advocate to facilitate access and improve communication, care, and outcomes in adults with moderate or severe asthma: Rationale, design, and methods of a randomized controlled trial

    Science.gov (United States)

    Apter, Andrea J.; Morales, Knashawn H.; Han, Xiaoyan; Perez, Luzmercy; Huang, Jingru; Ndicu, Grace; Localio, Anna; Nardi, Alyssa; Klusaritz, Heather; Rogers, Marisa; Phillips, Alexis; Cidav, Zuleyha; Schwartz, J. Sanford

    2017-01-01

    Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices. The PA coaches, models, and assists participants with preparations for a visit with the asthma clinician; attends the visit with permission of participant and provider; and confirms participants’ understanding of what transpired at the visit. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients’ unique social and administrative barriers to carrying out medical advice and transfer of information between providers and patients. PA activities are individualized, take account of comorbidities, and are generalizable to other chronic diseases. PAs are recent college graduates interested in health-related careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential participants. We test whether the PA intervention, compared to usual care, is associated with improved and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with the intervention’s cost-effectiveness. PMID:28315481

  1. Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

    Science.gov (United States)

    Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

    2015-10-09

    The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

  2. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial.

    Science.gov (United States)

    Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

    2017-01-01

    Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women's sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce. This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD. Two hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG) or a 6-month waitlist control group. Assessments take place at baseline (T1), peritreatment after completion of Session 5 in IG (T2), after completion of Session 8 or 12 weeks after randomization (T3), and after 6 months (T4). Data will be analyzed on an intention-to-treat and a completer basis. The primary outcome will be sexual intercourse involving the insertion of the partner's penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1) and investigated as a potential moderator of the primary treatment outcome. Given the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap. German Register of Clinical Studies (DRKS): DRKS00010228.

  3. The effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in cancer patients treated with radiotherapy: design of a cluster randomised controlled trial

    International Nuclear Information System (INIS)

    Braeken, Anna PBM; Lechner, Lilian; Gils, Francis CJM van; Houben, Ruud MA; Eekers, Daniëlle; Ambergen, Ton; Kempen, Gertrudis IJM

    2009-01-01

    The Screening Inventory of Psychosocial Problems (SIPP) is a short, validated self-reported questionnaire to identify psychosocial problems in Dutch cancer patients. The one-page 24-item questionnaire assesses physical complaints, psychological complaints and social and sexual problems. Very little is known about the effects of using the SIPP in consultation settings. Our study aims are to test the hypotheses that using the SIPP (a) may contribute to adequate referral to relevant psychosocial caregivers, (b) should facilitate communication between radiotherapists and cancer patients about psychosocial distress and (c) may prevent underdiagnosis of early symptoms reflecting psychosocial problems. This paper presents the design of a cluster randomised controlled trial (CRCT) evaluating the effectiveness of using the SIPP in cancer patients treated with radiotherapy. A CRCT is developed using a Solomon four-group design (two intervention and two control groups) to evaluate the effects of using the SIPP. Radiotherapists, instead of cancer patients, are randomly allocated to the experimental or control groups. Within these groups, all included cancer patients are randomised into two subgroups: with and without pre-measurement. Self-reported assessments are conducted at four times: a pre-test at baseline before the first consultation and a post-test directly following the first consultation, and three and 12 months after baseline measurement. The primary outcome measures are the number and types of referrals of cancer patients with psychosocial problems to relevant (psychosocial) caregivers. The secondary outcome measures are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life. Furthermore, a process evaluation will be carried out. Data of the effect-evaluation will be analysed according to the intention-to-treat principle and data regarding the types of referrals to health care providers and patient

  4. 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

  5. Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce

    2008-10-01

    Full Text Available Abstract Background The one year prevalence of thoracic back pain has been estimated as 17% compared to 64% for neck pain and 67% for low back pain. At present only one randomised controlled trial has been performed assessing the efficacy of spinal manipulative therapy (SMT for thoracic spine pain. In addition no high quality trials have been performed to test the efficacy and effectiveness of Graston Technique® (GT, a soft tissue massage therapy using hand-held stainless steel instruments. The objective of this trial is to determine the efficacy of SMT and GT compared to a placebo for the treatment of non specific thoracic spine pain. Methods Eighty four eligible people with non specific thoracic pain mid back pain of six weeks or more will be randomised to one of three groups, either SMT, GT, or a placebo (de-tuned ultrasound. Each group will receive up to 10 supervised treatment sessions at the Murdoch University Chiropractic student clinic over a 4-week period. Treatment outcomes will be measured at baseline, one week after their first treatment, upon completion of the 4-week intervention period and at three, six and twelve months post randomisation. Outcome measures will include the Oswestry Back Pain Disability Index and the Visual Analogue Scale (VAS. Intention to treat analysis will be utilised in the statistical analysis of any group treatment effects. Trial Registration This trial was registered with the Australia and New Zealand Clinical Trials Registry on the 7th February 2008. Trial number: ACTRN12608000070336

  6. The design and protocol of heat-sensitive moxibustion for knee osteoarthritis: a multicenter randomized controlled trial on the rules of selecting moxibustion location

    Directory of Open Access Journals (Sweden)

    Chi Zhenhai

    2010-06-01

    Full Text Available Abstract Background Knee osteoarthritis is a major cause of pain and functional limitation. Complementary and alternative medical approaches have been employed to relieve symptoms and to avoid the side effects of conventional medication. Moxibustion has been widely used to treat patients with knee osteoarthritis. Our past researches suggested heat-sensitive moxibustion might be superior to the conventional moxibustion. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion or conventional drug treatment. Methods This study consists of a multi-centre (four centers in China, randomised, controlled trial with three parallel arms (A: heat-sensitive moxibustion; B: conventional moxibustion; C: conventional drug group. The moxibustion locations are different from A and B. Group A selects heat-sensitization acupoint from the region consisting of Yin Lingquan(SP9, Yang Lingquan(GB34, Liang Qiu(ST34, and Xue Hai (SP10. Meanwhile, fixed acupoints are used in group B, that is Xi Yan (EX-LE5 and He Ding (EX-LE2. The conventional drug group treats with intra-articular Sodium Hyaluronate injection. The outcome measures above will be assessed before the treatment, the 30 days of the last moxibustion session and 6 months after the last moxibustion session. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It will provide evidence for the effectiveness of moxibustion as a treatment for moderate and severe knee osteoarthritis. Moreover, the result will clarify the rules of heat-sensitive moxibustion location to improve the therapeutic effect with suspended moxibustion, and propose a new concept and a new theory of moxibustion to guide clinical practices. Trial Registration The trial is registered at Controlled Clinical Trials: ChiCTR-TRC-00000600.

  7. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  8. Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Theodoros Deborah

    2007-03-01

    Full Text Available Abstract Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+ greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2 will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction

  9. Multidisciplinary Collaborative Care for Depressive Disorder in the Occupational Health Setting: design of a randomised controlled trial and cost-effectiveness study

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2008-05-01

    Full Text Available Abstract Background Major depressive disorder (MDD has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs and other health care professionals with occupational physicians (OPs. The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW. From a societal perspective, the (costeffectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting. Methods/Design A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST, a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU. 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness. Discussion The high burden of MDD and the high level of sickness absence among people with MDD contribute to

  10. Effectiveness and cost-effectiveness of 'BeweegKuur', a combined lifestyle intervention in the Netherlands: Rationale, design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kremers Stef PJ

    2011-10-01

    Full Text Available Abstract Background Improving the lifestyle of overweight and obese adults is of increasing interest in view of its role in several chronic diseases. Interventions aiming at overweight or weight-related chronic diseases suffer from high drop-out rates. It has been suggested that Motivational Interviewing and more frequent and more patient-specific coaching could decrease the drop-out rate. 'BeweegKuur' is a multidisciplinary lifestyle intervention which offers three programmes for overweight persons. The effectiveness and the cost-effectiveness of intensively guided programmes, such as the 'supervised exercise programme' of 'BeweegKuur', for patients with high weight-related health risk, remain to be assessed. Our randomized controlled trial compares the expenses and effects of the 'supervised exercise programme' with those of the less intensively supervised 'start-up exercise programme'. Methods/Design The one-year intervention period involves coaching by a lifestyle advisor, a physiotherapist and a dietician, coordinated by general practitioners (GPs. The participating GP practices have been allocated to the interventions, which differ only in terms of the amount of coaching offered by the physiotherapist. Whereas the 'start-up exercise programme' includes several consultations with physiotherapists to identify barriers hampering independent exercising, the 'supervised exercise programme' includes more sessions with a physiotherapist, involving exercise under supervision. The main goal is transfer to local exercise facilities. The main outcome of the study will be the participants' physical activity at the end of the one-year intervention period and after one year of follow-up. Secondary outcomes are dietary habits, health risk, physical fitness and functional capacity. The economic evaluation will consist of a cost-effectiveness analysis and a cost-utility analysis. The primary outcome measures for the economic evaluation will be the physical

  11. Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

    Science.gov (United States)

    Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M

    2016-05-10

    Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and

  12. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

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    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  13. Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

    Directory of Open Access Journals (Sweden)

    Moskowitz JT

    2014-09-01

    currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress. Keywords: positive affect, HIV diagnosis, stress, coping, RCT, intervention, physical health

  14. Pattern Recognition Control Design

    Science.gov (United States)

    Gambone, Elisabeth A.

    2018-01-01

    Spacecraft control algorithms must know the expected vehicle response to any command to the available control effectors, such as reaction thrusters or torque devices. Spacecraft control system design approaches have traditionally relied on the estimated vehicle mass properties to determine the desired force and moment, as well as knowledge of the effector performance to efficiently control the spacecraft. A pattern recognition approach was used to investigate the relationship between the control effector commands and spacecraft responses. Instead of supplying the approximated vehicle properties and the thruster performance characteristics, a database of information relating the thruster ring commands and the desired vehicle response was used for closed-loop control. A Monte Carlo simulation data set of the spacecraft dynamic response to effector commands was analyzed to establish the influence a command has on the behavior of the spacecraft. A tool developed at NASA Johnson Space Center to analyze flight dynamics Monte Carlo data sets through pattern recognition methods was used to perform this analysis. Once a comprehensive data set relating spacecraft responses with commands was established, it was used in place of traditional control methods and gains set. This pattern recognition approach was compared with traditional control algorithms to determine the potential benefits and uses.

  15. Sample size requirements for separating out the effects of combination treatments: Randomised controlled trials of combination therapy vs. standard treatment compared to factorial designs for patients with tuberculous meningitis

    Directory of Open Access Journals (Sweden)

    Farrar Jeremy

    2011-02-01

    Full Text Available Abstract Background In certain diseases clinical experts may judge that the intervention with the best prospects is the addition of two treatments to the standard of care. This can either be tested with a simple randomized trial of combination versus standard treatment or with a 2 × 2 factorial design. Methods We compared the two approaches using the design of a new trial in tuberculous meningitis as an example. In that trial the combination of 2 drugs added to standard treatment is assumed to reduce the hazard of death by 30% and the sample size of the combination trial to achieve 80% power is 750 patients. We calculated the power of corresponding factorial designs with one- to sixteen-fold the sample size of the combination trial depending on the contribution of each individual drug to the combination treatment effect and the strength of an interaction between the two. Results In the absence of an interaction, an eight-fold increase in sample size for the factorial design as compared to the combination trial is required to get 80% power to jointly detect effects of both drugs if the contribution of the less potent treatment to the total effect is at least 35%. An eight-fold sample size increase also provides a power of 76% to detect a qualitative interaction at the one-sided 10% significance level if the individual effects of both drugs are equal. Factorial designs with a lower sample size have a high chance to be underpowered, to show significance of only one drug even if both are equally effective, and to miss important interactions. Conclusions Pragmatic combination trials of multiple interventions versus standard therapy are valuable in diseases with a limited patient pool if all interventions test the same treatment concept, it is considered likely that either both or none of the individual interventions are effective, and only moderate drug interactions are suspected. An adequately powered 2 × 2 factorial design to detect effects of

  16. The Infant Fish Oil Supplementation Study (IFOS): design and research protocol of a double-blind, randomised controlled n--3 LCPUFA intervention trial in term infants.

    Science.gov (United States)

    Meldrum, S J; D'Vaz, N; Dunstan, J; Mori, T A; Prescott, S L

    2011-09-01

    The Infant Fish Oil Supplementation Study is a double-blind randomised controlled trial investigating whether the incidence of allergic disease can be reduced and developmental outcomes enhanced through supplementation with omega-3 fatty acids. Infants at high risk of developing allergic disease will be randomised to receive either fish oil or olive oil supplements until 6 months of age and followed up at six postnatal clinic visits to assess allergy outcomes and infant neurodevelopment. Study groups to consist of a treatment group allocated to receive 650 mg of fish oil daily (250-280 mg docosahexaenoic acid and at least 60 mg eicosapentaenoic acid and a placebo group (olive oil) from birth to 6 months of age. Allergy outcomes will be assessed by clinical history, clinical assessments and allergen skin prick tests at the 12, 30 and 60 month visits. Neurodevelopmental assessments to be conducted at 18 months, and language questionnaires at 12, 18 and 30 months. Samples will be collected from mothers antenatally, from infants at birth, and at clinic visits from 6 months onwards for immunological assessments. Fatty acid composition to be measured in erythrocytes and plasma (at birth and after the supplementation period) to assess the effect of the intervention on fatty acid status. Information on medical history, diet and other lifestyle factors at an antenatal clinic visit and postnatal clinic visits will also be collected. This study is designed to examine clinically relevant effects of a novel, non-invasive and potentially low cost approach to reduce the incidence of allergic disease and facilitate neurodevelopment during early childhood. Copyright © 2011 Elsevier Inc. All rights reserved.

  17. Demographic variables, design characteristics, and effect sizes of randomized, placebo-controlled, monotherapy trials of major depressive disorder and bipolar depression.

    Science.gov (United States)

    Papakostas, George I; Martinson, Max A; Fava, Maurizio; Iovieno, Nadia

    2016-05-01

    The aim of this work is to compare the efficacy of pharmacologic agents for the treatment of major depressive disorder (MDD) and bipolar depression. MEDLINE/PubMed databases were searched for studies published in English between January 1980 and September 2014 by cross-referencing the search term placebo with each of the antidepressant agents identified and with bipolar. The search was supplemented by manual bibliography review. We selected double-blind, randomized, placebo-controlled trials of antidepressant monotherapies for the treatment of MDD and of oral drug monotherapies for the treatment of bipolar depression. 196 trials in MDD and 19 trials in bipolar depression were found eligible for inclusion in our analysis. Data were extracted by one of the authors and checked for accuracy by a second one. Data extracted included year of publication, number of patients randomized, probability of receiving placebo, duration of the trial, baseline symptom severity, dosing schedule, study completion rates, and clinical response rates. Response rates for drug versus placebo in trials of MDD and bipolar depression were 52.7% versus 37.5% and 54.7% versus 40.5%, respectively. The random-effects meta-analysis indicated that drug therapy was more effective than placebo in both MDD (risk ratio for response = 1.373; P depression (risk ratio = 1.257; P depression trials in favor of MDD (P = .008). Although a statistically significantly greater treatment effect size was noted in MDD relative to bipolar depression studies, the absolute magnitude of the difference was numerically small. Therefore, the present study suggests no clinically significant differences in the overall short-term efficacy of pharmacologic monotherapies for MDD and bipolar depression. © Copyright 2016 Physicians Postgraduate Press, Inc.

  18. Improving return-to-work after childbirth: design of the Mom@Work study, a randomised controlled trial and cohort study.

    Science.gov (United States)

    Stomp-van den Berg, Suzanne G M; van Poppel, Mireille N M; Hendriksen, Ingrid J M; Bruinvels, David J; Uegaki, Kimi; de Bruijne, Martine C; van Mechelen, Willem

    2007-03-29

    Many women suffer from health problems after giving birth, which can lead to sick leave. About 30% of Dutch workers are on sick leave after maternity leave. Structural contact of supervisors with employees on maternity leave, supported by early medical advice of occupational physicians, may increase the chances of return-to-work after maternity leave. In addition, to understand the process of sick leave and return-to-work after childbirth it is important to gain insight into which factors hinder return-to-work after childbirth, as well, as which prognostic factors lead to the development of postpartum health complaints. In this paper, the design of the Mom@Work study is described. The Mom@Work study is simultaneously a randomised controlled trial and a cohort study. Pregnant women working for at least 12 hours a week at one of the 15 participating companies are eligible to participate. The supervisors of these pregnant employees are randomised at 35 weeks pregnancy into the intervention group or control group. During maternity leave, supervisors in the intervention group contact their employee six weeks after delivery using a structured interview. When employees do not expect to return to their jobs at the end of their scheduled maternity leave due to health problems, the supervisor offers early support of the occupational physician. Supervisors in the control group have no structural contact with their employees during maternity leave. Measurements take place at 30 weeks pregnancy and at 6, 12, 24 and 52 weeks postpartum. In addition, cost data are collected. For the RCT, primary outcome measures are sick leave and return-to-work, and secondary outcome measures are costs, health, satisfaction with intervention and global feelings of recovery. Outcome measures for the cohort are pregnancy-related pelvic girdle pain, fatigue and depression. Finally, a number of prognostic factors for return-to-work and for the development of complaints will be measured. The Mom

  19. Improving return-to-work after childbirth: design of the Mom@Work study, a randomised controlled trial and cohort study

    Directory of Open Access Journals (Sweden)

    Bruinvels David J

    2007-03-01

    Full Text Available Abstract Background Many women suffer from health problems after giving birth, which can lead to sick leave. About 30% of Dutch workers are on sick leave after maternity leave. Structural contact of supervisors with employees on maternity leave, supported by early medical advice of occupational physicians, may increase the chances of return-to-work after maternity leave. In addition, to understand the process of sick leave and return-to-work after childbirth it is important to gain insight into which factors hinder return-to-work after childbirth, as well, as which prognostic factors lead to the development of postpartum health complaints. In this paper, the design of the Mom@Work study is described. Methods The Mom@Work study is simultaneously a randomised controlled trial and a cohort study. Pregnant women working for at least 12 hours a week at one of the 15 participating companies are eligible to participate. The supervisors of these pregnant employees are randomised at 35 weeks pregnancy into the intervention group or control group. During maternity leave, supervisors in the intervention group contact their employee six weeks after delivery using a structured interview. When employees do not expect to return to their jobs at the end of their scheduled maternity leave due to health problems, the supervisor offers early support of the occupational physician. Supervisors in the control group have no structural contact with their employees during maternity leave. Measurements take place at 30 weeks pregnancy and at 6, 12, 24 and 52 weeks postpartum. In addition, cost data are collected. For the RCT, primary outcome measures are sick leave and return-to-work, and secondary outcome measures are costs, health, satisfaction with intervention and global feelings of recovery. Outcome measures for the cohort are pregnancy-related pelvic girdle pain, fatigue and depression. Finally, a number of prognostic factors for return-to-work and for the

  20. A randomized placebo-controlled trial of the effect of coffee consumption on insulin sensitivity: Design and baseline characteristics of the Coffee for METabolic Health (COMETH study

    Directory of Open Access Journals (Sweden)

    Derrick Johnston Alperet

    2016-12-01

    Trial registration: ClinicalTrials.gov identifier: NCT01738399. Registered on 28 November 2012. Trial Sponsor: Nestlé Research Center, Lausanne, Switzerland. Trial Site: National University of Singapore.

  1. Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests

    OpenAIRE

    Smith, Kirsty S; Hocking, Jane S; Chen, Marcus; Fairley, Christopher K; McNulty, Anna; Read, Phillip; Bradshaw, Catriona S; Tabrizi, Sepehr N; Wand, Handan; Saville, Marion; Rawlinson, William; Garland, Suzanne M; Donovan, Basil; Kaldor, John M; Guy, Rebecca

    2014-01-01

    Background Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups. ...

  2. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

    Science.gov (United States)

    Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

    2008-08-06

    Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

  3. The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design

    Directory of Open Access Journals (Sweden)

    Dowell Anthony C

    2007-07-01

    Full Text Available Abstract Background Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints. Methods The Women's Lifestyle Study is a two year randomized controlled trial involving a nurse-led intervention to increase physical activity in 40–74 year old physically inactive women recruited from primary care. Baseline measures were assessed in a face-to-face interview with a primary care nurse. The intervention involved delivery of a 'Lifestyle script' by a primary care nurse followed by telephone counselling for nine months and a face-to-face nurse visit at six months. Outcome measurements are assessed at 12 and 24 months. The primary outcome is physical activity measured using a validated physical activity questionnaire. Secondary outcomes include blood pressure, weight, waist circumference, physical fitness (step test, serum HbA1c, fasting glucose, lipids, insulin, and quality of life (SF36. Costs were measured prospectively to allow a subsequent cost-effectiveness evaluation if the trial is positive. Discussion Due to report in 2008, the Women's Lifestyle Study tests the effectiveness of an enhanced low-cost, evidence-based intervention in increasing physical activity, and improving cardiovascular and diabetes risk indicators over two years. If successful in demonstrating improvements in health outcomes, this randomized controlled trial will be the first to demonstrate long-term cardiovascular and diabetes risk health benefit, in addition to improvements in physical activity, from a sustainable physical activity intervention based in primary care. Trial Registration Australian Clinical Trials

  4. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    International Nuclear Information System (INIS)

    Ruiter, Marieke A de; Meeteren, Antoinette YN Schouten-Van; Mourik, Rosa van; Janssen, Tieme WP; Greidanus, Juliette EM; Oosterlaan, Jaap; Grootenhuis, Martha A

    2012-01-01

    Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. ClinicalTrials.gov NCT00961922

  5. The GRONORUN study: is a graded training program for novice runners effective in preventing running related injuries? Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Pepping Gert-Jan

    2007-03-01

    Full Text Available Abstract Background Running is a popular form of recreational exercise. Beside the positive effects of running on health and fitness, the risk of a running related injury has to be considered. The incidence of injuries in runners is high and varies from 30–79%. However, few intervention studies on prevention of running related injuries have been performed and none of these studies involved novice runners. Methods GRONORUN (Groningen Novice Running is a two armed randomized controlled trial, comparing the effects of two different training programs for novice runners on the incidence of running related injuries. Participants are novice runners, who want to train for a four mile running event. The control group will train according a standard 8 week training program. The intervention group will use a more gradual, 13 week training program which is based on "the ten percent training rule". During the thirteen week follow up participants register information on running and RRI's in an internet based running log. The primary outcome measure is RRI. An injury is defined as a musculoskeletal ailment of the lower extremity or back, causing a restriction of running for at least one week. Discussion The GRONORUN trial is the first randomized controlled trial to study a preventive intervention in novice runners. Many different training programs for novice runners are offered, but none are evidence based.

  6. Design of clinical trials Phase I and II with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Giannone, C.A.; Soroa, V.E.

    2015-01-01

    We presented some usual designs for clinical studies in Phase I and Phase II. For Phase I we considered the 3 + 3 Classic design, designs with accelerated titration and those with dose escalation schemes with overdose control (EWOC). For Phase II designs with efficacy outcomes are presented. The design proposed by Fleming is discussed as well as those with inclusion of patients in two stages: Gehan’s design and the Optimal two–stage Simon’s design. We also discussed the design of combined endpoints of efficacy and safety of Bryant and Day with an application example of therapeutically Lu-177. Finally some proposals for phase II trials with control group are considered. (authors) [es

  7. Sample size requirements for separating out the effects of combination treatments: randomised controlled trials of combination therapy vs. standard treatment compared to factorial designs for patients with tuberculous meningitis.

    Science.gov (United States)

    Wolbers, Marcel; Heemskerk, Dorothee; Chau, Tran Thi Hong; Yen, Nguyen Thi Bich; Caws, Maxine; Farrar, Jeremy; Day, Jeremy

    2011-02-02

    In certain diseases clinical experts may judge that the intervention with the best prospects is the addition of two treatments to the standard of care. This can either be tested with a simple randomized trial of combination versus standard treatment or with a 2 x 2 factorial design. We compared the two approaches using the design of a new trial in tuberculous meningitis as an example. In that trial the combination of 2 drugs added to standard treatment is assumed to reduce the hazard of death by 30% and the sample size of the combination trial to achieve 80% power is 750 patients. We calculated the power of corresponding factorial designs with one- to sixteen-fold the sample size of the combination trial depending on the contribution of each individual drug to the combination treatment effect and the strength of an interaction between the two. In the absence of an interaction, an eight-fold increase in sample size for the factorial design as compared to the combination trial is required to get 80% power to jointly detect effects of both drugs if the contribution of the less potent treatment to the total effect is at least 35%. An eight-fold sample size increase also provides a power of 76% to detect a qualitative interaction at the one-sided 10% significance level if the individual effects of both drugs are equal. Factorial designs with a lower sample size have a high chance to be underpowered, to show significance of only one drug even if both are equally effective, and to miss important interactions. Pragmatic combination trials of multiple interventions versus standard therapy are valuable in diseases with a limited patient pool if all interventions test the same treatment concept, it is considered likely that either both or none of the individual interventions are effective, and only moderate drug interactions are suspected. An adequately powered 2 x 2 factorial design to detect effects of individual drugs would require at least 8-fold the sample size of the

  8. Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial.

    Science.gov (United States)

    Heber, Elena; Ebert, David Daniel; Lehr, Dirk; Nobis, Stephanie; Berking, Matthias; Riper, Heleen

    2013-07-15

    Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a

  9. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

    Science.gov (United States)

    Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

    2011-05-06

    Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

  10. [Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

    Science.gov (United States)

    Hartholt, Klaas A; Boyé, Nicole D A; Van der Velde, Nathalie; Van Lieshout, Esther M M; Polinder, Suzanne; De Vries, Oscar J; Kerver, Albert J H; Ziere, Gijsbertus; Bruijninckx, Milko M M; De Vries, Mark R; Mattace-Raso, Francesco U S; Uitterlinden, André G; Van Beeck, Ed F; Lips, Paul; Patka, Peter; Van der Cammen, Tischa J M

    2011-08-21

    Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. The trial is registered in the Netherlands Trial Register (NTR1593).

  11. Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests.

    Science.gov (United States)

    Smith, Kirsty S; Hocking, Jane S; Chen, Marcus; Fairley, Christopher K; McNulty, Anna; Read, Phillip; Bradshaw, Catriona S; Tabrizi, Sepehr N; Wand, Handan; Saville, Marion; Rawlinson, William; Garland, Suzanne M; Donovan, Basil; Kaldor, John M; Guy, Rebecca

    2014-04-24

    Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups. The REACT (retest after Chlamydia trachomatis) trial involves 600 patients diagnosed with chlamydia: 200 MSM, 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice. Participants will be randomised to the home group (3-month SMS reminder and home-collection) or the clinic group (3-month SMS reminder to return to the clinic). Participants in the home group will be given the choice of attending the clinic if they prefer. The mailed home-collection kit includes a self-collected vaginal swab (women), UriSWAB (Copan) for urine collection (heterosexual men), and UriSWAB plus rectal swab (MSM). The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis, and the secondary outcomes are: the repeat positive test rate; the reinfection rate; the acceptability of home testing with SMS reminders; and the cost effectiveness of home testing. Sexual behaviour data collected via an online survey at 4-5 months, and genotyping of repeat infections, will be used to discriminate reinfections from treatment failures. The trial will be conducted over two years. An intention to treat analysis will be conducted. This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting, repeat infection and reinfection rates in three risk groups. The trial will determine client acceptability and cost effectiveness of this strategy. Australian and New

  12. Big Data in Designing Clinical Trials: Opportunities and Challenges.

    Science.gov (United States)

    Mayo, Charles S; Matuszak, Martha M; Schipper, Matthew J; Jolly, Shruti; Hayman, James A; Ten Haken, Randall K

    2017-01-01

    Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

  13. Big Data in Designing Clinical Trials: Opportunities and Challenges

    Directory of Open Access Journals (Sweden)

    Charles S. Mayo

    2017-08-01

    Full Text Available Emergence of big data analytics resource systems (BDARSs as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

  14. A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

    Science.gov (United States)

    Johnson, Miriam J; Booth, Sara; Currow, David C; Lam, Lawrence T; Phillips, Jane L

    2016-05-01

    The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom. To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures. This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion. Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome. A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  15. Screening for type 2 diabetes in a high-risk population: study design and feasibility of a population-based randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Klijs Bart

    2012-08-01

    Full Text Available Abstract Background We describe the design and present the results of the first year of a population-based study of screening for type 2 diabetes in individuals at high risk of developing the disease. High risk is defined as having abdominal obesity. Methods Between 2006 and 2007, 79,142 inhabitants of two Dutch municipalities aged 40–74 years were approached to participate in screening. Eligible participants had a self-reported waist circumference of ≥80 cm for women and ≥94 cm for men, and no known pre-existing diabetes. Of the respondents (n = 20,578; response rate 26%, 16,135 were abdominally obese. In total, 10,609 individuals gave written informed consent for participation and were randomized into either the screening (n = 5305 or the control arm (n = 5304. Participants in the screening arm were invited to have their fasting plasma glucose (FPG measured and were referred to their general practitioner (GP if it was ≥6.1 mmol/L. In addition, blood lipids were determined in the screening arm, because abdominal obesity is often associated with cardiovascular risk factors. Participants in both arms received written healthy lifestyle information. Between-group differences were analyzed with Chi-square tests and logistic regression (categorical variables and unpaired t-tests (continuous variables. Results The screening attendance rate was 84.1%. Attending screening was associated with age at randomization (OR = 1.03, 95% CI 1.02-1.04, being married (OR = 1.57, 95% CI 1.33-1.83 and not-smoking currently (OR = 0.52, 95% CI 0.44-0.62. Of the individuals screened, 5.6% had hyperglycemia, and a further 11.6% had an estimated absolute cardiovascular disease risk of 5% or higher, according to the Systematic Coronary Risk Evaluation risk model. These participants were referred to their GP. Conclusions Self-reported home-assessed waist circumference could feasibly detect persons at high risk of hyperglycemia or

  16. Effectiveness and cost-effectiveness of an internet intervention for family caregivers of people with dementia: design of a randomized controlled trial.

    Science.gov (United States)

    Blom, Marco M; Bosmans, Judith E; Cuijpers, Pim; Zarit, Steve H; Pot, Anne Margriet

    2013-01-10

    The number of people with dementia is rising rapidly as a consequence of the greying of the world population. There is an urgent need to develop cost effective approaches that meet the needs of people with dementia and their family caregivers. Depression, feelings of burden and caregiver stress are common and serious health problems in these family caregivers. Different kinds of interventions are developed to prevent or reduce the negative psychological consequences of caregiving. The use of internet interventions is still very limited, although they may be a cost effective way to support family caregivers in an earlier stage and diminish their psychological distress in the short and longer run. A pragmatic randomized controlled trial is designed to evaluate the effectiveness and cost-effectiveness of 'Mastery over Dementia', an internet intervention for caregivers of people with dementia. The intervention aims at prevention and decrease of psychological distress, in particular depressive symptoms. The experimental condition consists of an internet course with 8 sessions and a booster session over a maximum period of 6 months guided by a psychologist. Caregivers in the comparison condition receive a minimal intervention. In addition to a pre and post measurement, an intermediate measurement will be conducted. In addition, there will be two follow-up measurements 3 and 6 months after post-treatment in the experimental group only. To study the effectiveness of the intervention, depressive symptoms are used as the primary outcome, whereas symptoms of anxiety, role overload and caregiver perceived stress are used as secondary outcomes. To study which caregivers profit most of the internet intervention, several variables that may modify the impact of the intervention are taken into account. Regarding the cost-effectiveness, an economic evaluation will be conducted from a societal perspective. This study will provide evidence about the effectiveness and cost

  17. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

    Science.gov (United States)

    Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

    2013-05-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination. Copyright © 2013. Published by Elsevier Inc.

  18. The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

    Science.gov (United States)

    Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

    2015-01-01

    To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  19. Efficacy and safety of bilateral continuous theta burst stimulation (cTBS for the treatment of chronic tinnitus: design of a three-armed randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Plontke Stefan K

    2009-08-01

    Full Text Available Abstract Background Tinnitus, the perception of sound and noise in absence of an auditory stimulus, has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex. Transient modulation of tinnitus by repetitive transcranial magnetic stimulation (rTMS indicated that these areas are critically involved in the pathophysiology of tinnitus and suggested new treatment strategies. However, the therapeutic efficacy of rTMS in tinnitus is still unclear, individual response is variable, and the optimal stimulation area disputable. Recently, continuous theta burst stimulation (cTBS has been put forward as an effective rTMS protocol for the reduction of pathologically enhanced cortical excitability. Methods 48 patients with chronic subjective tinnitus will be included in this randomized, placebo controlled, three-arm trial. The treatment consists of two trains of cTBS applied bilaterally to the secondary auditory cortex, the temporoparietal associaction cortex, or to the lower occiput (sham condition every working day for four weeks. Primary outcome measure is the change of tinnitus distress as quantified by the Tinnitus Questionnaire (TQ. Secondary outcome measures are tinnitus loudness and annoyance as well as tinnitus change during and after treatment. Audiologic and speech audiometric measurements will be performed to assess potential side effects. The aim of the present trail is to investigate effectiveness and safety of a four weeks cTBS treatment on chronic tinnitus and to compare two areas of stimulation. The results will contribute to clarify the therapeutic capacity of rTMS in tinnitus. Trial registration The trial was registered with the clinical trials register of http://www.clinicaltrials.gov (NCT00518024.

  20. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. The TOPSHOCK study: effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial.

    Science.gov (United States)

    van der Worp, Henk; Zwerver, Johannes; van den Akker-Scheek, Inge; Diercks, Ron L

    2011-10-11

    Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. The TOPSHOCK study is the first randomised controlled trial that

  2. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ

    Directory of Open Access Journals (Sweden)

    Kielbassa Andrej M

    2011-04-01

    Full Text Available Abstract Background Hyposalivation is caused by various syndromes, diabetes, drugs, inflammation, infection, or radiotherapy of the salivary glands. Patients with hyposalivation often show an increased caries incidence. Moreover, hyposalivation is frequently accompanied by oral discomfort and impaired oral functions, and saliva substitutes are widely used to alleviate oral symptoms. However, preference of saliva substitutes due to taste, handling, and relief of oral symptoms has been discussed controversially. Some of the marketed products have shown demineralizing effects on dental hard tissues in vitro. This demineralizing potential is attributed to the undersaturation with respect to calcium phosphates. Therefore, it is important to modify the mineralizing potential of saliva substitutes to prevent carious lesions. Thus, the aim of the present study was to evaluate the effects of a possible remineralizing saliva substitute (SN; modified Saliva natura compared to a demineralizing one (G; Glandosane on mineral parameters of sound bovine dentin and enamel as well as on artificially demineralized enamel specimens in situ. Moreover, oral well-being after use of each saliva substitute was recorded. Methods/Design Using a randomized, double-blind, crossover, phase II/III in situ trial, volunteers with hyposalivation utilize removable dentures containing bovine specimens during the experimental period. The volunteers are divided into two groups, and are required to apply both saliva substitutes for seven weeks each. After both test periods, differences in mineral loss and lesion depth between values before and after exposure are evaluated based on microradiographs. The oral well-being of the volunteers before and after therapy is determined using questionnaires. With respect to the microradiographic analysis, equal mineral losses and lesion depths of enamel and dentin specimens during treatment with SN and G, and no differences in patients

  3. A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial.

    Science.gov (United States)

    Coffeng, Jennifer K; van der Ploeg, Hidde P; Castellano, José M; Fernández-Alvira, Juan M; Ibáñez, Borja; García-Lunar, Inés; van der Beek, Allard J; Fernández-Ortiz, Antonio; Mocoroa, Agustín; García-Leal, Laura; Cárdenas, Evelyn; Rojas, Carolina; Martínez-Castro, María I; Santiago-Sacristán, Silvia; Fernández-Gallardo, Miriam; Mendiguren, José M; Bansilal, Sameer; van Mechelen, Willem; Fuster, Valentín

    2017-02-01

    Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  4. Rationale, design and methods for a randomised and controlled trial to investigate whether home access to electronic games decreases children's physical activity

    Directory of Open Access Journals (Sweden)

    Piek Jan P

    2009-06-01

    Full Text Available Abstract Background Many children are reported to have insufficient physical activity (PA placing them at greater risk of poor health outcomes. Participating in sedentary activities such as playing electronic games is widely believed to contribute to less PA. However there is no experimental evidence that playing electronic games reduces PA. There is also no evidence regarding the effect of different types of electronic games (traditional sedentary electronic games versus new active input electronic games on PA. Further, there is a poor understanding about how characteristics of children may moderate the impact of electronic game access on PA and about what leisure activities are displaced when children play electronic games. Given that many children play electronic games, a better understanding of the effect of electronic game use on PA is critical to inform child health policy and intervention. Methods This randomised and controlled trial will examine whether PA is decreased by access to electronic games and whether any effect is dependent on the type of game input or the child's characteristics. Children aged 10–12 years (N = 72, 36 females will be recruited and randomised to a balanced ordering of 'no electronic games', 'traditional' electronic games and 'active' electronic games. Each child will participate in each condition for 8 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is PA, assessed by Actical accelerometers worn for 7 days on the wrist and hip. Energy expenditure will be assessed by the doubly labelled water technique and motor coordination, adiposity, self-confidence, attitudes to technology and PA and leisure activities will also be assessed. A sample of 72 will provide a power of > 0.9 for detecting a 15 mins difference in PA (sd = 30 mins. Discussion This is the first such trial and will provide critical information to understand whether access to electronic games affects

  5. The implementation effectiveness of the 'Strengthen your ankle' smartphone application for the prevention of ankle sprains: design of a randomized controlled trial.

    Science.gov (United States)

    Van Reijen, Miriam; Vriend, Ingrid I; Zuidema, Victor; van Mechelen, Willem; Verhagen, Evert A

    2014-01-07

    Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App ('Strenghten your ankle' translated in Dutch as: 'Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The 'Strengthen your ankle' App has not been evaluated against the 'regular' prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the 'Strengthen your ankle' App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice. The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive 'Strengthen your ankle' App. This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to

  6. Use of risk stratification to target therapies in patients with recent onset arthritis; design of a prospective randomized multicenter controlled trial

    Directory of Open Access Journals (Sweden)

    Claessen Susanne JJ

    2009-06-01

    Full Text Available Abstract Background Early and intensive treatment is important to inducing remission and preventing joint damage in patients with rheumatoid arthritis. While intensive combination therapy (Disease Modifying Anti-rheumatic Drugs and/or biologicals is the most effective, rheumatologists in daily clinical practice prefer to start with monotherapy methotrexate and bridging corticosteroids. Intensive treatment should be started as soon as the first symptoms manifest, but at this early stage, ACR criteria may not be fulfilled, and there is a danger of over-treatment. We will therefore determine which induction therapy is most effective in the very early stage of persistent arthritis. To overcome over-treatment and under-treatment, the intensity of induction therapy will be based on a prediction model that predicts patients' propensity for persistent arthritis. Methods A multicenter stratified randomized single-blind controlled trial is currently being performed in patients 18 years or older with recent-onset arthritis. Eight hundred ten patients are being stratified according to the likelihood of their developing persistent arthritis. In patients with a high probability of persistent arthritis, we will study combination Disease Modifying Antirheumatic Drug therapy compared to monotherapy methotrexate. In patients with an intermediate probability of persistent arthritis, we will study Disease Modifying Antirheumatic Drug of various intensities. In patients with a low probability, we will study non-steroidal anti-inflammatory drugs, hydroxychloroquine and a single dose of corticosteroids. If disease activity is not sufficiently reduced, treatment will be adjusted according to a step-up protocol. If remission is achieved for at least six months, medication will be tapered off. Patients will be followed up every three months over two years. Discussion This is the first rheumatological study to base treatment in early arthritis on a prediction rule

  7. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

    Science.gov (United States)

    Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

    2018-01-08

    The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

  8. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

    Science.gov (United States)

    Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

    2015-05-01

    Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

  9. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  10. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale

    Science.gov (United States)

    Arnold, Benjamin F; Null, Clair; Luby, Stephen P; Unicomb, Leanne; Stewart, Christine P; Dewey, Kathryn G; Ahmed, Tahmeed; Ashraf, Sania; Christensen, Garret; Clasen, Thomas; Dentz, Holly N; Fernald, Lia C H; Haque, Rashidul; Hubbard, Alan E; Kariger, Patricia; Leontsini, Elli; Lin, Audrie; Njenga, Sammy M; Pickering, Amy J; Ram, Pavani K; Tofail, Fahmida; Winch, Peter J; Colford, John M

    2013-01-01

    Introduction Enteric infections are common during the first years of life in low-income countries and contribute to growth faltering with long-term impairment of health and development. Water quality, sanitation, handwashing and nutritional interventions can independently reduce enteric infections and growth faltering. There is little evidence that directly compares the effects of these individual and combined interventions on diarrhoea and growth when delivered to infants and young children. The objective of the WASH Benefits study is to help fill this knowledge gap. Methods and analysis WASH Benefits includes two cluster-randomised trials to assess improvements in water quality, sanitation, handwashing and child nutrition—alone and in combination—to rural households with pregnant women in Kenya and Bangladesh. Geographically matched clusters (groups of household compounds in Bangladesh and villages in Kenya) will be randomised to one of six intervention arms or control. Intervention arms include water quality, sanitation, handwashing, nutrition, combined water+sanitation+handwashing (WSH) and WSH+nutrition. The studies will enrol newborn children (N=5760 in Bangladesh and N=8000 in Kenya) and measure outcomes at 12 and 24 months after intervention delivery. Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea. Secondary outcomes include stunting prevalence, markers of environmental enteropathy and child development scores (verbal, motor and personal/social). We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests. Ethics and dissemination Study protocols have been reviewed and approved by human subjects review boards at the University of California, Berkeley, Stanford University, the International Centre for Diarrheal Disease Research, Bangladesh, the Kenya Medical Research Institute, and Innovations for Poverty Action. Independent data safety monitoring

  11. 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

    2013-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  12. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Veldhuis, Lydian; Struijk, Mirjam K; Kroeze, Willemieke; Oenema, Anke; Renders, Carry M; Bulk-Bunschoten, Anneke Mw; Hirasing, Remy A; Raat, Hein

    2009-06-08

    The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change.The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games), parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years), and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the use of this protocol will result in a healthier lifestyle of the

  13. Screenings of lung cancer with low dose spiral CT: results of a three year pilot study and design of the randomised controlled trial Italung-CT

    International Nuclear Information System (INIS)

    Picozzi, Giulia; Paci, Enrico; Lopes Pegna, Andrea

    2005-01-01

    Purpose: To report the results of a three-year observational pilot study of lung cancer screening with low dose computed tomography (CT) and to present the study design of a randomised clinical trial named as Italung CT. Materials and methods: Sixty (47 males and 13 females, mean age 64±4.5 years) heavy smokers (at least 20 packs-year) underwent three low-dose spiral CT screening tests one year apart on a single slice or multislice CT scanner. Indeterminate nodules were managed according to the recommendations of the Early Lung Cancer Action Project. Results: Indeterminate nodules were observed in 33 (55%) of the subjects (60% at the baseline screening test, 24% at the first annual test and 16% at the second annual test). The size of the largest indeterminate nodule was [it

  14. Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial.

    Science.gov (United States)

    Cao, Hui-Juan; Liu, Jian-Ping; Hu, Hui; Wang, Nissi S

    2014-07-10

    Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality. This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).

  15. WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

    Directory of Open Access Journals (Sweden)

    Vernooij-Dassen Myrra

    2009-10-01

    Full Text Available Abstract Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver

  16. Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Myers, Bronwyn; Lund, Crick; Lombard, Carl; Joska, John; Levitt, Naomi; Butler, Christopher; Cleary, Susan; Naledi, Tracey; Milligan, Peter; Stein, Dan J; Sorsdahl, Katherine

    2018-03-16

    In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models

  17. Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Lee Myoungsook

    2011-01-01

    Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

  18. Lessons learned from the London Exercise and Pregnant (LEAP Smokers randomised controlled trial process evaluation: implications for the design of physical activity for smoking cessation interventions during pregnancy

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    Nikoletta Giatras

    2017-01-01

    Full Text Available Abstract Background The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved. Methods Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures. Topics included recruitment, retention and how the physical activity intervention for pregnant smokers was delivered and how it was adapted when necessary to suit the women. The focus groups were audio-recorded, transcribed verbatim and subjected to thematic analysis. Results Five themes emerged related to barriers or enablers to intervention delivery: (1 nature of the intervention; (2 personal characteristics of trial participants; (3 practical issues; (4 researchers’ engagement with participants; (5 training and support needs. Researchers perceived that participants may have been deterred by the intensive and generic nature of the intervention and the need to simultaneously quit smoking and increase physical activity. Women also appeared hampered by pregnancy ailments, social deprivation, and poor mental health. Researchers observed that thei