Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

2016-04-27

Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

DEFF Research Database (Denmark)

Krarup, L.H.; Gluud, C.; Truelsen, T.

2008-01-01

of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

Illness Management & Recovery (IMR) in the Netherlands : A naturalistic pilot study to explore the feasibility of a randomized controlled trial

NARCIS (Netherlands)

Roosenschoon, B.J.; Van Weeghel, J.; Bogaards, M.; Deen, M.L.; Mulder, C.L.

2016-01-01

Background Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of

Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial

NARCIS (Netherlands)

B.J. Roosenschoon (Bert); J. van Weeghel (Jaap); Bogaards, M. (Moniek); M. Deen (Mathijs); C.L. Mulder (Niels)

2016-01-01

textabstractBackground: Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the

Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

Science.gov (United States)

Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

2017-11-01

The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period. NCT01900262. A total of 52 of the 129 (40%) novice runners experienced at least one running related injury: 21 in the functional strength training program, 16 in the resistance strength training program and 15 in the control stretching program. Injury rates did not differ between study groups [IR = 32.9 (95% CI 20.8, 49.3) in the functional group, IR = 31.6 (95% CI 18.4, 50.5) in the resistance group, and IR = 26.7 (95% CI 15.2, 43.2)] in the control group. Although this was a pilot assessment, home-based strength training did not appear to alter injury rates compared to stretching. Future studies should consider methods to minimize participant drop out to allow for the assessment of injury risk. Injury risk in novice runners based on this pilot study will inform the development of future larger studies investigating the impact of injury prevention interventions. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

DEFF Research Database (Denmark)

Kruse, A Y; Kjaergard, L L; Krogsgaard, K

2000-01-01

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

Science.gov (United States)

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: a pilot randomized controlled trial.

Science.gov (United States)

Prins, Jan C M; Stubbe, Janine H; van Meeteren, Nico L U; Scheffers, Frans A; van Dongen, Martien C J M

2011-05-01

To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. A pilot version of an intended prospective randomized controlled clinical trial was conducted. A total of 19 patients with an acute tear in the gastrocnemius muscle were randomly allocated to either active or control treatment. The intervention consisted of the repeated application of crushed ice. Primary outcome measures were functional capacity and reconvalescence time. Secondary outcome measures were pain and work absenteeism. The number of patients we could include within the 6-hour time window and dropping out from the pilot study were regarded as indicators of the feasibility of ice therapy. A total of 16 patients were excluded from the study because diagnosis was not made within 6 hours after onset of the complaint. The 19 patients included completed the treatment. For functional capacity, reconvalescence time, work absenteeism and pain relief, no significant differences between the intervention and control group were found. The execution of a randomized controlled trial on ice therapy for acute gastrocnemius tear is feasible though quite an enterprise. First, it is recommended to improve the recruitment processes. Second, power analysis demands inclusion of 396 participants. Preliminary effectiveness in our limited-sized trial indicates that the use of ice is not beneficial for people who receive ice therapy.

Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Rickard Kristen

2011-03-01

Full Text Available Abstract Background Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. Methods We used a prospective, randomized, open-label, blinded-endpoint (PROBE study design. Pregnant women presenting at Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg or usual care (screening result is not revealed, no treatment. The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth Results Of 779 women approached, 500 (64% participated in candidiasis screening, and 98 (19.6% had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. Conclusions A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609001052224

External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE pilot trial

Directory of Open Access Journals (Sweden)

Sheila M. Bird

2017-03-01

Full Text Available The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released.

Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

Science.gov (United States)

Khot, Sandeep P.; Davis, Arielle P.; Crane, Deborah A.; Tanzi, Patricia M.; Li Lue, Denise; Claflin, Edward S.; Becker, Kyra J.; Longstreth, W.T.; Watson, Nathaniel F.; Billings, Martha E.

2016-01-01

Study Objectives: Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. Methods: In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. Results: Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). Conclusions: A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding—though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials. Citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Li Lue D, Claflin ES, Becker KJ, Longstreth WT, Watson NF, Billings ME. Effect of continuous positive airway pressure on stroke rehabilitation: a pilot randomized sham-controlled trial. J Clin Sleep Med 2016;12(7):1019–1026. PMID

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

Science.gov (United States)

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

2018-01-01

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

Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

Science.gov (United States)

Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

2015-12-01

Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.

Science.gov (United States)

Deem, Steven; Yanez, David; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam

2016-01-01

Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP. A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP

Overcoming Barriers to Disseminating Exposure Therapies for Anxiety Disorders: A Pilot Randomized Controlled Trial of Training Methods

OpenAIRE

Harned, Melanie S.; Dimeff, Linda A.; Woodcock, Eric A.; Skutch, Julie M.

2011-01-01

The present study evaluated methods for training mental health providers (N=46) in exposure therapies (ETs) for anxiety disorders. A pilot randomized controlled trial compared: 1) an interactive, multimedia online training (ET OLT), 2) the ET OLT plus a brief Motivational Interviewing-based intervention (ET OLT + MI), and 3) a placebo control OLT. Assessments were completed at baseline, post-training, and one week following training. Both ET OLT and ET OLT + MI received high satisfaction rati...

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

Science.gov (United States)

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

Science.gov (United States)

Sood, Beena G; Keszler, Martin; Garg, Meena; Klein, Jonathan M; Ohls, Robin; Ambalavanan, Namasivayam; Cotten, C Michael; Malian, Monica; Sanchez, Pablo J; Lakshminrusimha, Satyan; Nelin, Leif D; Van Meurs, Krisa P; Bara, Rebecca; Saha, Shampa; Das, Abhik; Wallace, Dennis; Higgins, Rosemary D; Shankaran, Seetha

2014-12-12

Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary

Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomized controlled trial.

Science.gov (United States)

Clark, Julia; Holgan, Nikki; Craig, Leone; Morgan, Heather; Danielian, Peter; Devereux, Graham

2016-11-01

Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16-19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1-4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41-8.77) at 12 weeks, 6.41 mg/d (5.07-7.75) at 20 weeks, and 6.67 mg/d (5.38-7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21-7.79) at 12 weeks to 14.9 mg/d (13.3-16.4) at 20 weeks and 15.2 mg/d (12.9-17.5) at 34 weeks, P  clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16-25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.

Honest, Open, Proud for adolescents with mental illness: pilot randomized controlled trial.

Science.gov (United States)

Mulfinger, Nadine; Müller, Sabine; Böge, Isabel; Sakar, Vehbi; Corrigan, Patrick W; Evans-Lacko, Sara; Nehf, Luise; Djamali, Julia; Samarelli, Anna; Kempter, Michael; Ruckes, Christian; Libal, Gerhard; Oexle, Nathalie; Noterdaeme, Michele; Rüsch, Nicolas

2018-06-01

Due to public stigma or self-stigma and shame, many adolescents with mental illness (MI) struggle with the decision whether to disclose their MI to others. Both disclosure and nondisclosure are associated with risks and benefits. Honest, Open, Proud (HOP) is a peer-led group program that supports participants with disclosure decisions in order to reduce stigma's impact. Previously, HOP had only been evaluated among adults with MI. This two-arm pilot randomized controlled trial included 98 adolescents with MI. Participants were randomly assigned to HOP and treatment as usual (TAU) or to TAU alone. Outcomes were assessed pre (T0/baseline), post (T1/after the HOP program), and at 3-week follow-up (T2/6 weeks after T0). Primary endpoints were stigma stress at T1 and quality of life at T2. Secondary outcomes included self-stigma, disclosure-related distress, empowerment, help-seeking intentions, recovery, and depressive symptoms. The trial is registered on ClinicalTrials (NCT02751229; http://www.clinicaltrials.gov). Compared to TAU, adolescents in the HOP program showed significantly reduced stigma stress at T1 (d = .92, p self-stigma, disclosure-related distress, secrecy, help-seeking intentions, attitudes to disclosure, recovery, and depressive symptoms. Effects at T1 remained stable or improved further at follow-up. In a limited economic evaluation HOP was cost-efficient in relation to gains in quality of life. As HOP is a compact three-session program and showed positive effects on stigma and disclosure variables as well as on symptoms and quality of life, it could help to reduce stigma's negative impact among adolescents with MI. © 2017 Association for Child and Adolescent Mental Health.

Recruitment for 'A pilot study of randomized controlled trial to evaluate the efficacy of lung cancer screening by thoracic CT'

International Nuclear Information System (INIS)

Sagawa, Motoyasu; Tanaka, Makoto; Mizukami, Satoru

2011-01-01

The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)

Problem-solving skills training for parents of children with chronic pain: a pilot randomized controlled trial.

Science.gov (United States)

Palermo, Tonya M; Law, Emily F; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C

2016-06-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem-solving skills training (PSST) compared with treatment as usual on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional, and physical functioning) were also examined. Participants included 61 parents of children aged 10 to 17 years with chronic pain randomized to PSST (n = 31) or treatment as usual (n = 30) groups. Parents receiving PSST participated in 4 to 6 individual sessions of training in problem-solving skills. Outcomes were assessed at pretreatment, immediately after treatment, and at a 3-month follow-up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with posttreatment improvements in parental depression (d = -0.68), general mental health (d = 0.64), and pain catastrophizing (d = -0.48), as well as in child depression (d = -0.49), child general anxiety (d = -0.56), and child pain-specific anxiety (d = -0.82). Several effects were maintained at the 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youths with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results.

Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

Science.gov (United States)

van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

2014-02-01

Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ineke Van Der Meulen

2016-11-01

Full Text Available AbstractMelodic Intonation Therapy (MIT is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT. Subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list randomized controlled trial design. Patients with chronic (>1 year post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT or to the control group (6 weeks no intervention followed by 6 weeks MIT. Assessments were done at baseline (T1, after 6 weeks (T2, and 6 weeks later (T3. Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β=13.32, p=.02. This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This

Wean earlier and automatically with new technology (the WEAN study). A multicenter, pilot randomized controlled trial.

Science.gov (United States)

Burns, Karen E A; Meade, Maureen O; Lessard, Martin R; Hand, Lori; Zhou, Qi; Keenan, Sean P; Lellouche, Francois

2013-06-01

Automated weaning has not been compared with a paper-based weaning protocol in North America. We conducted a pilot randomized trial comparing automated weaning with protocolized weaning in critically ill adults to evaluate clinician compliance and acceptance of the weaning and sedation protocols, recruitment, and impact on outcomes. From August 2007 to October 2009, we enrolled critically ill adults requiring more than 24 hours of mechanical ventilation and at least partial reversal of the condition precipitating respiratory failure at nine Canadian intensive care units. We randomized patients who tolerated at least 30 minutes of pressure support and either failed or were not yet ready to undergo a spontaneous breathing trial to automated or protocolized weaning. Both groups used pressure support, included spontaneous breathing trials, used a common positive end-expiratory pressure-FI(O(2)) chart, sedation protocol, and criteria for extubation, reintubation, and noninvasive ventilation. We recruited 92 patients (49 automated, 43 protocolized) over 26 months. Adherence to assigned weaning protocols and extreme sedation scale scores fell within prespecified thresholds. Combined physician-respiratory therapist and nurse acceptance scores of the study weaning and sedation protocols, respectively, were not significantly different. Automated weaning patients had significantly shorter median times to first successful spontaneous breathing trial (1.0 vs. 4.0 d; P 4.0 d; P = 0.02), and successful extubation (4.0 vs. 5.0 d; P = 0.01), and underwent fewer tracheostomies and episodes of protracted ventilation. Compared with a standardized protocol, automated weaning was associated with promising outcomes that warrant further investigation. Minor protocol modifications may increase compliance, facilitate recruitment, and enhance feasibility. Clinical trial registered with www.controlled-trials.com (ISRCTN43760151).

Muscle energy technique compared to eccentric loading exercise in the management of achilles tendinitis: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Hariharasudhan Ravichandran

2017-01-01

Full Text Available Background: Achilles tendinitis is a common overuse injury among both elite and recreational athletes involved in activities such as repetitive jumping and running. Aim: The aim of this single-blinded randomized study was to compare the efficacy of muscle energy technique (MET and eccentric loading exercise (ELE interventions on improving functional ability and pain reduction among athletes with Achilles tendinitis. Methods: A single-blinded, pilot, randomized study was conducted in the Department of Physical Therapy, Global Hospitals and Health City, India, with 6-week follow-up. A total of 30 patients with Achilles tendinitis were randomly allocated to receive either MET (n = 15 or ELE (n = 15 treatment. Treatment effects were evaluated by pre- and post-treatment assessment of visual analog scale (VAS and Victorian Institute of Sports Assessment-Achilles (VISA-A questionnaire. Measures were performed by single-blinded evaluators at baseline and at 2, 4, and after 6 weeks of treatment. Results: Both groups showed a significant difference in VAS after 6 weeks' ELE group showed a significant improvement during treatment at 2 and 4 weeks in comparison with MET group. The VISA-A scale score significantly improved in both groups. Yet, comparison of VISA scores between groups showed marginally significant difference (P = 0.012. Conclusion: This pilot randomized controlled trial (RCT showed the efficacy of ELE in reducing pain and improving functional ability among patients with Achilles tendinitis. The findings of this study provide the rationale for undertaking a large-scale RCT. A large sized trial is needed to establish evidence for clinical practice of ELE in Achilles tendinitis cases.

An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial

Directory of Open Access Journals (Sweden)

Mark W. Vander Weg

2016-08-01

Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.

Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

Science.gov (United States)

Bachman, Jessica L; Raynor, Hollie A

2012-05-01

Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

Science.gov (United States)

Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors.

Science.gov (United States)

Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

2013-02-01

This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER), as compared to a matched-contact control intervention targeting physical activity (MoveMore). Both 5-week interventions included two interactive group sessions and three support telephone calls. Executing a patient-centered developmental process, the primary aim of this paper was to evaluate patient feedback on intervention content and structure. The secondary aim was to understand the potential reach (i.e., proportion enrolled, representativeness) and effectiveness (i.e. health behaviors, theorized mediating variables, quality of life) of SipSmartER. Twenty-five participants were randomized to SipSmartER (n=14) or MoveMore (n=11). Participants' intervention feedback was positive, ranging from 4.2-5.0 on a 5-point scale. Qualitative assessments reavealed several opportunties to improve clarity of learning materials, enhance instructions and communication, and refine research protocols. Although SSB consumption decreased more among the SipSmartER participants (-256.9 ± 622.6 kcals), there were no significant group differences when compared to control participants (-199.7 ± 404.6 kcals). Across both groups, there were significant improvements for SSB attitudes, SSB behavioral intentions, and two media literacy constructs. The value of using a patient-centered approach in the developmental phases of this intervention was apparent, and pilot findings suggest decreased SSB may be achieved through targeted health literacy and TPB strategies. Future efforts are needed to examine

Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial

DEFF Research Database (Denmark)

Højskov, Ida E; Moons, Philip; Hansen, Niels V

2015-01-01

BACKGROUND: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However......, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. AIMS: The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment......, patient acceptance of the intervention, safety and tolerability of the intervention. METHODS AND DESIGN: Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise...

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

Science.gov (United States)

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

Meal-Replacements followed by Topiramate for the Treatment of Adolescent Severe Obesity: A Pilot Randomized Controlled Trial

Science.gov (United States)

Fox, Claudia K.; Kaizer, Alexander M.; Rudser, Kyle D.; Nathan, Brandon M.; Gross, Amy C.; Sunni, Muna; Abuzzahab, M. Jennifer; Schwartz, Betsy L.; Kumar, Seema; Petryk, Anna; Billington, Charles J.; Ryder, Justin R.; Kelly, Aaron S.

2016-01-01

Objective The objective of this pilot study was to assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Methods Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Results Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (−1.9% [95% CI (−5.2%, +1.5%); P=0.291]). Significant improvements in visceral fat and VLDL-c were observed in the topiramate compared to the placebo group. There were no concerning changes in neurocognitive function or bone health. Conclusion In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared to meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. PMID:27807925

Symptomatic treatment (ibuprofen or antibiotics (ciprofloxacin for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Wegscheider Karl

2010-05-01

Full Text Available Abstract Background Uncomplicated lower urinary tract infections (UTI are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options. This pilot study was set out 1 to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2 to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. Methods We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg (+1 placebo oral, both for three days. Intensity of main symptoms - dysuria, frequency, low abdominal pain - was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none to 4 (very strong. The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms, symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. Results Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39. On Day 4, 21/36 (58.3% of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5% in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42 than ciprofloxacin patients (1,3; SD 1,9, difference -0,33 (95% CI (-1,13 to +0,47, PP (per protocol analysis. During Days 0 and 9, 12/36 (33% of patients

The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL Pilot Trial

Directory of Open Access Journals (Sweden)

Lauren Galbraith

2014-11-01

Full Text Available Background: Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain. Objectives: We undertook a pilot RCT to determine the feasibility of a larger trial. Design: Pilot randomized controlled trial. Setting: Single center Canadian outpatient nephrology clinic. Patients: Participants with systemic lupus erythematosus (SLE and a history of class III or IV lupus nephritis that achieved at least partial remission and remained on prednisone were eligible. Measurements: Feasibility: proportion of eligible patients randomized and adherence to tapering regimen. Clinical: occurrence of renal or major non-renal flare of SLE. Methods: We conducted a blinded, two-parallel-group randomized controlled trial of prednisone 7.5 mg/day (continuation compared to a matching placebo (withdrawal. Results: Of nineteen eligible patients screened, 15 (79% were recruited and randomized; 8 to prednisone continuation and seven to withdrawal. All participants adhered to the tapering protocol to their assigned withdrawal or low-dose maintenance target. Over 36 months, the primary outcome occurred in four (50% patients in the continuation group (three renal and one major non-renal flare, compared with one patient (14% in the withdrawal group (one renal flare. Three participants (38% in the continuation group had minor flares, while no patients in the withdrawal group did. Limitations: This pilot RCT was small and not designed to assess the efficacy or safety of maintenance with low-dose prednisone. Conclusions: The high proportion of eligible patients recruited, and success of protocol adherence suggest a large trial of prednisone maintenance therapy compared to withdrawal is feasible. Trial registration: Current Controlled Trials ISRCTN31327267.

'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.

Science.gov (United States)

Tu, Xiang; Liu, Fang; Jordan, James B; Ye, Xue Feng; Fu, Ping; Wang, Fei; Zhong, Sen

2013-07-18

Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups: 1. A granule group, at 10 grams, three times daily (G10 group, n = 12); 2. A granule group, at 20 grams, three times daily (G20 group, n = 12); 3. A decoction group (D group, n = 12); and 4. An irbesartan group (Aprovel group, n = 12).The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial. It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820).

Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial.

Science.gov (United States)

Kolko, Rachel P; Kass, Andrea E; Hayes, Jacqueline F; Levine, Michele D; Garbutt, Jane M; Proctor, Enola K; Wilfley, Denise E

This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal setting) among nursing students. Participants (N = 63) were randomized to live interactive training or Web-facilitated self-study training. Pretraining, post-training, and 1-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Nearly all participants (98%) completed assessments. Both types of training were acceptable, with higher ratings for live training and participants with previous experience (ps pediatric obesity services. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

Science.gov (United States)

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: A pilot randomized controlled trial

NARCIS (Netherlands)

Oosting, E.; Jans, M.P.; Dronkers, J.J.; Naber, R.H.; Dronkers-Landman, C.M.; Appelman-De Vries, S.M.; Meeteren, N.L. van

2012-01-01

Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: a pilot randomized controlled trial. Objective: To investigate the feasibility and preliminary effectiveness of a home-based intensive exercise

A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

Science.gov (United States)

Whitley, Julie Anne; Rich, Bonnie L

2008-12-01

To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder.

Science.gov (United States)

Mataix-Cols, David; Fernández de la Cruz, Lorena; Isomura, Kayoko; Anson, Martin; Turner, Cynthia; Monzani, Benedetta; Cadman, Jacinda; Bowyer, Laura; Heyman, Isobel; Veale, David; Krebs, Georgina

2015-11-01

Body dysmorphic disorder (BDD) typically starts in adolescence, but evidence-based treatments are yet to be developed and formally evaluated in this age group. We designed an age-appropriate cognitive-behavioral therapy (CBT) protocol for adolescents with BDD and evaluated its acceptability and efficacy in a pilot randomized controlled trial. Thirty adolescents aged 12 to 18 years (mean = 16.0, SD = 1.7) with a primary diagnosis of BDD, together with their families, were randomly assigned to 14 sessions of CBT delivered over 4 months or a control condition of equivalent duration, consisting of written psycho-education materials and weekly telephone monitoring. Blinded evaluators assessed participants at baseline, midtreatment, posttreatment, and at 2-month follow-up. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, Adolescent Version (mean baseline score = 37.13, SD = 4.98, range = 24-43). The CBT group showed a significantly greater improvement than the control group, both at posttreatment (time × group interaction coefficient [95% CI] = -11.26 [-17.22 to -5.31]; p = .000) and at 2-month follow-up (time × group interaction coefficient [95% CI] = -9.62 [-15.74 to -3.51]; p = .002). Six participants (40%) in the CBT group and 1 participant (6.7%) in the control condition were classified as responders at both time points (χ(2) = 4.658, p = .031). Improvements were also seen on secondary measures, including insight, depression, and quality of life at posttreatment. Both patients and their families deemed the treatment as highly acceptable. Developmentally tailored CBT is a promising intervention for young people with BDD, although there is significant room for improvement. Further clinical trials incorporating lessons learned in this pilot study and comparing CBT and pharmacological therapies, as well as their combination, are warranted. Cognitive-Behaviour Therapy for Adolescents With Body Dysmorphic Disorder; http

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

Science.gov (United States)

2014-01-01

Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

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

Science.gov (United States)

Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

2012-06-01

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

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

International Nuclear Information System (INIS)

Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

2012-01-01

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

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

Science.gov (United States)

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

Science.gov (United States)

Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

2007-12-01

Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy.

Science.gov (United States)

Advani, Pragati; Brewster, Abenaa M; Baum, George P; Schover, Leslie R

2017-08-01

A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers. Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale. Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04). Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months. This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

Science.gov (United States)

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

Science.gov (United States)

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Patient participation in cancer clinical trials: A pilot test of lay navigation

Directory of Open Access Journals (Sweden)

Kathleen B. Cartmell

2016-08-01

Conclusions: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

Science.gov (United States)

Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

2015-06-05

Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

Science.gov (United States)

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

Science.gov (United States)

Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

2015-01-01

Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial

Directory of Open Access Journals (Sweden)

Uchenna Okafor

2017-02-01

Full Text Available Abstract Background The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs having a prevalence of 27.4%, six times higher than the prevalence in the general population. Methods/design The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

Science.gov (United States)

Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

2016-03-31

Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

2017-08-04

Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Vigod, Simone; Dennis, Cindy-Lee; Daskalakis, Zafiris; Murphy, Kellie; Ray, Joel; Oberlander, Tim; Somerton, Sarah; Hussain-Shamsy, Neesha; Blumberger, Daniel

2014-09-18

Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population. We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum. Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

Science.gov (United States)

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

Science.gov (United States)

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Prchal Alice

2012-01-01

Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

Science.gov (United States)

Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

2018-01-01

Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

A pilot randomized trial teaching mindfulness-based stress reduction to traumatized youth in foster care.

Science.gov (United States)

Jee, Sandra H; Couderc, Jean-Philippe; Swanson, Dena; Gallegos, Autumn; Hilliard, Cammie; Blumkin, Aaron; Cunningham, Kendall; Heinert, Sara

2015-08-01

This article presents a pilot project implementing a mindfulness-based stress reduction program among traumatized youth in foster and kinship care over 10 weeks. Forty-two youth participated in this randomized controlled trial that used a mixed-methods (quantitative, qualitative, and physiologic) evaluation. Youth self-report measuring mental health problems, mindfulness, and stress were lower than anticipated, and the relatively short time-frame to teach these skills to traumatized youth may not have been sufficient to capture significant changes in stress as measured by electrocardiograms. Main themes from qualitative data included expressed competence in managing ongoing stress, enhanced self-awareness, and new strategies to manage stress. We share our experiences and recommendations for future research and practice, including focusing efforts on younger youth, and using community-based participatory research principles to promote engagement and co-learning. CLINICALTRIALS.GOV: Protocol Registration System ID NCT01708291. Copyright © 2015 Elsevier Ltd. All rights reserved.

Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial

DEFF Research Database (Denmark)

L, Ledderer; KI, Cour; O, Mogensen

2013-01-01

. We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair. Objective The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life. Methods...... significant difference was observed between the intervention and the control group. Pairs reported that the time of inclusion was inconvenient and that rehabilitation ought to meet their changing needs. Conclusions The pilot study showed that it may be difficult to conduct an RCT of a psychosocial...... rehabilitation intervention for pairs, and difficulties with inclusion and drop out have to be addressed. Interventions need to be carefully developed and tested before evaluating an effect in a large-scale study....

A systematic review of the usage of flow diagram in cluster randomized trials

Directory of Open Access Journals (Sweden)

Kostić M.

2014-01-01

Full Text Available Flow diagram represent an integral part of consolidated standards of reporting trials (CONSORT. Its use in reporting cluster randomization trials is highly recommended. The aim of this article is to present frequency of the use of flow diagram in cluster randomized trials in accordance with standards of reporting. The team has researched Medline database and singled-out 474 studies with cluster randomization for analysis. The studies were reviewed to identify the use of graphic representation, compliance with standards of reporting and the date when study was published. Depending from its duration, studies were divided on completed, and those still ongoing. Usage of CONSORT is recorded in 145 (31% literature units. Frequency of flow diagram was statistically much higher in studies which were in compliance with standards (86,2%, in comparison to those which did not use CONSORT guidelines (71,4%, as well as in completed studies (81,2% in comparison to pilot project studies (54,3%. Number of cluster randomized trials gathered through MEDLINE's search of key words 'cluster randomized trial [ti]' and 'cluster randomised trial [ti]', as well as the use of CONSORT in the reports of cluster randomized trials, are showing linear growth over time (p<0,001. Frequency of flow diagram is higher in the reports of cluster randomized trials that were done in accordance with the standards of reporting.

Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment.

Science.gov (United States)

Johns, Shelley A; Von Ah, Diane; Brown, Linda F; Beck-Coon, Kathleen; Talib, Tasneem L; Alyea, Jennifer M; Monahan, Patrick O; Tong, Yan; Wilhelm, Laura; Giesler, R Brian

2016-06-01

Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated. Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.

Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

2015-06-18

Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

Pilot clinical trial of dehydroepiandrosterone (DHEA) versus placebo for Sjögren's syndrome

NARCIS (Netherlands)

Pillemer, Stanley R.; Brennan, Michael T.; Sankar, Vidya; Leakan, Rose Anne; Smith, Janine A.; Grisius, Margaret; Ligier, Sophie; Radfar, Lida; Kok, Marc R.; Kingman, Albert; Fox, Philip C.

2004-01-01

To screen for potential efficacy and assess feasibility and safety of dehydroepiandrosterone (DHEA) as a treatment for Sjögren's syndrome (SS). A 24-week randomized, double-blinded, pilot trial of oral DHEA (200 mg/day) versus placebo was conducted. The primary comparison was to a hypothesized 20%

Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial.

Science.gov (United States)

Morrill, Kristin E; Aceves, Benjamin; Valdez, Luis A; Thomson, Cynthia A; Hakim, Iman A; Bell, Melanie L; Martinez, Jessica A; Garcia, David O

2018-02-09

-reactive protein (hs-CRP). This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial. NCT02911753 ( ClinicalTrials.gov ). Registered September 19, 2016. Last updated November 1, 2017.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

Directory of Open Access Journals (Sweden)

Pai Menaka

2013-01-01

Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

Science.gov (United States)

Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

2017-01-01

The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population. The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary

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

Science.gov (United States)

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

2016-10-01

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

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

Science.gov (United States)

Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-01-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension.

Science.gov (United States)

Jacobs, Lotte; Persu, Alexandre; Huang, Qi-Fang; Lengelé, Jean-Philippe; Thijs, Lutgarde; Hammer, Frank; Yang, Wen-Yi; Zhang, Zhen-Yu; Renkin, Jean; Sinnaeve, Peter; Wei, Fang-Fei; Pasquet, Agnès; Fadl Elmula, Fadl Elmula M; Carlier, Marc; Elvan, Arif; Wunder, Cora; Kjeldsen, Sverre E; Toennes, Stefan W; Janssens, Stefan; Verhamme, Peter; Staessen, Jan A

2017-12-01

Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age efficacy endpoint, and 2.5 mL/min/1.73 m 2 (+1.5 vs. -1.1 mL/min/1.73 m 2 ; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. The INSPiRED pilot suggests that RDN with the EnligHTN ™ system is effective and safe and generated insights useful for the design of future RDN trials.

Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

Science.gov (United States)

Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

2016-08-01

Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

Acupuncture for alcohol withdrawal: a randomized controlled trial.

Science.gov (United States)

Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter

2003-01-01

Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.

Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

Directory of Open Access Journals (Sweden)

Lynne Shinto

Full Text Available Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS. Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30. Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.ClinicalTrials.gov NCT00122954.

A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

Science.gov (United States)

Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

2017-03-04

Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

An evidence-based walking program among older people with knee osteoarthritis: the PEP (participant exercise preference) pilot randomized controlled trial.

Science.gov (United States)

Loew, Laurianne; Brosseau, Lucie; Kenny, Glen P; Durand-Bush, Natalie; Poitras, Stéphane; De Angelis, Gino; Wells, George A

2017-07-01

Knee osteoarthritis is a common joint problem leading to an increase of pain and a loss of function in older individuals. The main objective of this study was to evaluate if a participant who was randomly assigned to his preferred group improved his adherence to an effective walking program compared to a participant who did not receive his preferred group. This was a 9-month pilot randomized clinical trial, based on a patient treatment preferences design. The 69 eligible participants had a diagnosis of knee osteoarthritis. Participants were randomized to one of two groups: a supervised community-based or unsupervised walking program, based on the Ottawa Panel guidelines. At 6 months, participants who expressed a preference, either for the supervised or unsupervised program, and who were assigned to their preferred choice of program showed significantly higher adherence to walking sessions (supervised 60.7 ± 12.3%, P walking program, while ensuring the maintenance of clinical benefits of walking, among older adults susceptible to avoid or not properly engage in physical activity.

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

Effect of Mozart music on heel prick pain in preterm infants: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Cristina Cavaiuolo

2015-02-01

Full Text Available Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU. Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out in the NICU of the “G. Rummo” Hospital in Benevento, Italy. The sample consisted of 42 preterm infants, with no hearing loss or significant cerebral lesions on cranial ultrasound. They were randomized to receive heel lance during a music condition or a no-music control condition. We set strict criteria for selecting and delivering the music. Baseline and postprocedural heart rate and transcutaneous oxygen saturation were manually recorded. The Premature Infant Pain Profile (PIPP score was used to measure the behavioral response to prick. An unpaired t-test was performed for the intergroup comparisons.Results: There were significant differences between groups on heart rate increase, oxygen saturation reduction and PIPP score following the procedure.Conclusions: Listening to Mozart music during heel prick is a simple and inexpensive tool for pain alleviating in preterm stable neonates.

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial.

Science.gov (United States)

Goldstein, Tina R; Fersch-Podrat, Rachael K; Rivera, Maribel; Axelson, David A; Merranko, John; Yu, Haifeng; Brent, David A; Birmaher, Boris

2015-03-01

The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). We recruited participants 12-18 years of age with a primary BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly over 1 year. Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation. DBT may offer promise as an adjunct to pharmacotherapy in the treatment of depressive symptoms and suicidal ideation for

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

Science.gov (United States)

Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

2017-03-01

To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

Science.gov (United States)

Weeks, Douglas L; Whitney, Anthony A; Tindall, Angelique G; Carter, Gregory T

2015-10-01

The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. This study is a prospective, randomized pilot trial. Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

Science.gov (United States)

Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

Science.gov (United States)

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients.

Science.gov (United States)

Kleidon, Tricia M; Ullman, Amanda J; Gibson, Victoria; Chaseling, Brett; Schoutrop, Jason; Mihala, Gabor; Rickard, Claire M

2017-11-01

To evaluate feasibility of an efficacy trial comparing peripherally inserted central catheter (PICC) dressing and securement techniques to prevent complications and failure. This pilot, 3-armed, randomized controlled trial was undertaken at Royal Children's Hospital and Lady Cilento Children's Hospital, Brisbane, Australia, between April 2014 and September 2015. Pediatric participants (N = 101; age range, 0-18 y) were assigned to standard care (bordered polyurethane [BPU] dressing, sutureless securement device), tissue adhesive (TA) (plus BPU dressing), or integrated securement dressings (ISDs). Average PICC dwell time was 8.1 days (range, 0.2-27.7 d). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were PICC complications, dressing performance, and parent and staff satisfaction. Protocol feasibility was established. PICC failure was 6% (2/32) with standard care, 6% (2/31) with ISD, and 3% (1/32) with TA. PICC complications were 16% across all groups. TA provided immediate postoperative hemostasis, prolonging the first dressing change until 5.5 days compared with 3.5 days and 2.5 days with standard care and ISD respectively. Bleeding was the most common reason for first dressing change: standard care (n = 18; 75%), ISD (n = 11; 69%), TA (n = 4; 27%). Parental satisfaction (median 9.7/10; P = .006) and staff feedback (9.2/10; P = .002) were most positive for ISD. This research suggests safety and acceptability of different securement dressings compared with standard care; securement dressings may also reduce dressing changes after insertion. Further research is required to confirm clinically cost-effective methods to prevent PICC failure. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

Directory of Open Access Journals (Sweden)

Seungwon Shin

2016-01-01

Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

Science.gov (United States)

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial.

Science.gov (United States)

Fox, Claudia K; Kaizer, Alexander M; Rudser, Kyle D; Nathan, Brandon M; Gross, Amy C; Sunni, Muna; Jennifer Abuzzahab, M; Schwartz, Betsy L; Kumar, Seema; Petryk, Anna; Billington, Charles J; Ryder, Justin R; Kelly, Aaron S

2016-12-01

To assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m 2 ) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m 2 ) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (-1.9%; 95% CI: -5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very-low-density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health. In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. © 2016 The Obesity Society.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

A Pilot Randomized Trial of a Companion Robot for People With Dementia Living in the Community.

Science.gov (United States)

Liang, Amy; Piroth, Isabell; Robinson, Hayley; MacDonald, Bruce; Fisher, Mark; Nater, Urs M; Skoluda, Nadine; Broadbent, Elizabeth

2017-10-01

To investigate the affective, social, behavioral, and physiological effects of the companion robot Paro for people with dementia in both a day care center and a home setting. A pilot block randomized controlled trial over 12 weeks. Participants were randomized to the intervention (Paro) or control condition (standard care). Two dementia day care centers and participants' homes in Auckland, New Zealand. Thirty dyads (consisting of a care recipient with dementia and their caregiver) took part in this study. All care recipients attended dementia day care centers at Selwyn Foundation and had a formal diagnosis of dementia. Thirty-minute unstructured group sessions with Paro at the day care center were run 2 to 3 times a week for 6 weeks. Participants also had Paro at home for 6 weeks. At the day care centers, observations of the care recipients' behavior, affect, and social responses were recorded using a time sampling method. Observations of interactions with Paro for participants in the intervention were also recorded. Blood pressure and salivary cortisol were collected from care recipients before and after sessions at day care. In the home setting, level of cognition, depressive symptoms, neuropsychiatric symptoms, behavioral agitation, and blood pressure were measured at baseline, 6 weeks, and 12 weeks. Hair cortisol measures were collected at baseline and at 6 weeks. Observations showed that Paro significantly improved facial expressions (affect) and communication with staff (social interaction) at the day care centers. Subanalyses showed that care recipients with less cognitive impairment responded significantly better to Paro. There were no significant differences in care recipient dementia symptoms, nor physiological measures between the intervention and control group. Paro shows promise in enhancing affective and social outcomes for certain individuals with dementia in a community context. Larger randomized controlled trials in community settings, with

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

Science.gov (United States)

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

A pilot randomized, controlled trial of metformin versus insulin in women with type 2 diabetes mellitus during pregnancy.

Science.gov (United States)

Refuerzo, Jerrie S; Gowen, Rose; Pedroza, Claudia; Hutchinson, Maria; Blackwell, Sean C; Ramin, Susan

2015-02-01

Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

Science.gov (United States)

Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

2017-12-13

Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

Science.gov (United States)

Mikocka-Walus, Antonina; Hughes, Patrick A; Bampton, Peter; Gordon, Andrea; Campaniello, Melissa A; Mavrangelos, Chris; Stewart, Benjamin J; Esterman, Adrian; Andrews, Jane M

2017-04-01

Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.]. © European Crohn’s and Colitis Organistion (ECCO) 2016.

Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial.

Science.gov (United States)

Højskov, Ida E; Moons, Philip; Hansen, Niels V; Greve, Helle; Olsen, Dorte Bæk; Cour, Søren La; Glud, Christian; Winkel, Per; Lindschou, Jane; Egerod, Ingrid; Christensen, Anne Vinggaard; Berg, Selina Kikkenborg

2016-10-01

Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment, patient acceptance of the intervention, safety and tolerability of the intervention. Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise and psycho-educational plus usual care, or 4) usual care alone during a four week period after surgery. The acceptability of trial participation was 67% during the three month recruitment period. In the physical exercise groups, patients complied with 59% of the total expected training sessions during hospitalization. Nine patients (30%) complied with >75% and nine patients (30%) complied with 50% of the planned exercise sessions. Eleven patients (42%) participated in ⩾75% of the four consultations and six patients (23%) participated in 50% of the psycho-educational programme. Comprehensive phase one rehabilitation combining physical exercise and psycho-education in coronary artery bypass graft patients shows reasonably high inclusion, feasibility and safety. © The European Society of Cardiology 2015.

A randomized controlled trial of an electronic informed consent process.

Science.gov (United States)

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

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.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

Science.gov (United States)

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

Enhancing trunk stability in acute poststroke subjects using physioball exercise and proprioceptive neuromuscular facilitation technique: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ravichandran Hariharasudhan

2016-01-01

Full Text Available Background: Stroke is one of the leading causes of death and disability worldwide. Poststroke, most survivors experience trunk control impairment and instability. Previous works on exercise on an unstable surface to improve trunk stability in nonstroke population had proven effective. Thus, physioball exercises (PBEs in poststroke subjects may be useful in the recovery of trunk stability and thereby reduce disability. We hypothesize that PBE is feasible and effective in enhancing trunk stability. Aims: To test the feasibility and successful implementation of conducting a randomized controlled study to assess the clinical effectiveness of PBE and proprioceptive neuromuscular facilitation (PNF technique to enhance trunk control in poststroke subjects. Methods: This study was conducted in a stroke unit of Global Hospitals and Health City, Chennai, India. Thirty patients with the first onset of stroke within 40 days of stroke duration, lesion to one side, and ability to sit independently with or without arm support for 15 days were recruited. All thirty poststroke subjects were randomized either into PBE group or PNF group, and outcome assessors involved in the trail were blinded to allocation. PBE group performed task-oriented activities on an unstable surface and PNF group were treated with PNF-specific trunk stability exercise program for 4 weeks (30 min/day, 5 times/week. Trunk impairment scale (TIS was used as a main outcome measure. Results: Data were analyzed using Wilcoxon signed rank sum test and Mann–Whitney U-test for intra- and inter-group comparison. The baseline characteristics between both groups were statistically nonsignificant. Within groups, there were significant improvements between baseline and at 4 weeks in the measure of TIS. In addition, PBE group showed a significant increase in trunk control (mean 2.33, 95% confidence interval 1.14-3.52, P = 0.002 than the PNF subject. Conclusion: This pilot randomized controlled trial

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ceren Acarturk

2015-05-01

Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

Science.gov (United States)

Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

Science.gov (United States)

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Effects of guided imagery on blood pressure in pregnant women with hypertension: a pilot randomized controlled trial.

Science.gov (United States)

Moffatt, Faith Wight; Hodnett, Ellen; Esplen, Mary Jane; Watt-Watson, Judy

2010-12-01

Hypertension occurs in nearly 10 percent of pregnancies, and is associated with higher risk of infant and maternal morbidity and mortality than in normal pregnancies. Previous studies have suggested that relaxation therapies reduce blood pressure in nonpregnant adults. The objectives of this pilot randomized trial were to provide preliminary evidence of whether relaxation by means of guided imagery would reduce blood pressure in hypertensive pregnant women, and to assess the feasibility of a larger trial. A total of 69 pregnant women with hypertension were randomized to periods of guided imagery or of quiet rest, twice daily for 4 weeks or until delivery, whichever came first. Daytime ambulatory mean arterial pressure, systolic and diastolic blood pressure, and anxiety were measured weekly for up to 4 weeks. Women allocated to guided imagery had lower mean arterial pressure elevations over time than those allocated to quiet rest (guided imagery: M = 1.58 mmHg, SD = 7.63; quiet rest: M = 5.93 mmHg, SD = 6.55; t = 2.36, p = 0.02). However, when adjusted for baseline mean arterial pressure and gestation, the effect was not significant (p = 0.14). Numbers of women prescribed antihypertensive medication postrandomization were similar (guided imagery: n = 16; quiet rest: n = 13, χ(2) = 0.74, p = 0.46). There was also no evidence of an effect on women's anxiety. Nearly 90 percent (n = 26) of the guided imagery group indicated that they would use it again. Further rigorous study is warranted to determine effects of guided imagery on maternal blood pressure and perinatal health outcomes. © 2010, Copyright the Authors. Journal compilation © 2010, Wiley Periodicals, Inc.

Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

Science.gov (United States)

Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

2013-03-05

Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

Science.gov (United States)

Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, Francisco

2017-01-01

Background Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery

A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

Directory of Open Access Journals (Sweden)

Peterson Caroline D

2012-06-01

Full Text Available Abstract Background This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results Fifty-seven participants were randomized into the exercise (n = 22, spinal manipulation (n = 15, and Neuro Emotional Technique (n = 20 treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically

Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

Science.gov (United States)

Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

2016-01-01

Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

Science.gov (United States)

McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

2016-12-01

Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

Effect of continuous oral suctioning on the development of ventilator-associated pneumonia: a pilot randomized controlled trial.

Science.gov (United States)

Chow, Meyrick C M; Kwok, Shu-Man; Luk, Hing-Wah; Law, Jenny W H; Leung, Bartholomew P K

2012-11-01

Both continuous and intermittent aspiration of subglottic secretions by means of specially designed endotracheal tubes containing a separate dorsal lumen that opens into the subglottic region have been shown to be useful in reducing ventilator-associated pneumonia (VAP). However, the high cost of these tubes restricts their use. The aim of this pilot randomized controlled trial was to test the effect of a low-cost device (saliva ejector) for continuous oral suctioning (COS) on the incidence of VAP in patients receiving mechanical ventilation. The study was conducted in the six-bed medical-surgical ICU of a hospital with over 400 beds that provides comprehensive medical services to the public. The design of this study was a parallel-group randomized controlled trial. While both the experimental and control groups used the conventional endotracheal tube, the saliva ejector was only applied to patients assigned to the experimental group. The device was put between the patient's cheek and teeth, and then connected to 100mmHg of suction for the continuous drainage of saliva. Fourteen patients were randomized to receive COS and 13 patients were randomized to the control group. The two groups were similar in demographics, reasons for intubation, co-morbidity, and risk factors for acquiring VAP. VAP was found in 3 patients (23.1%; 71 episodes of VAP per 1000 ventilation days) receiving COS and in 10 patients (83.3%; 141 episodes of VAP per 1000 ventilation days) in the control group (relative risk, 0.28; 95% confidence interval, 0.10-0.77; p=0.003). The duration of mechanical ventilation in the experimental group was 3.2 days (SD 1.3), while that in the control group was 5.9 days (SD 2.8) (p=0.009); and the length of ICU stay was 4.8 days (SD 1.6) versus 9.8 days (SD 6.3) for the experimental and control groups, respectively (p=0.019). Continuous clearance of oral secretion by the saliva ejector may have an important role to play in reducing the rate of VAP, decreasing the

Attention Measures of Accuracy, Variability, and Fatigue Detect Early Response to Donepezil in Alzheimer's Disease: A Randomized, Double-blind, Placebo-Controlled Pilot Trial.

Science.gov (United States)

Vila-Castelar, Clara; Ly, Jenny J; Kaplan, Lillian; Van Dyk, Kathleen; Berger, Jeffrey T; Macina, Lucy O; Stewart, Jennifer L; Foldi, Nancy S

2018-04-09

Donepezil is widely used to treat Alzheimer's disease (AD), but detecting early response remains challenging for clinicians. Acetylcholine is known to directly modulate attention, particularly under high cognitive conditions, but no studies to date test whether measures of attention under high load can detect early effects of donepezil. We hypothesized that load-dependent attention tasks are sensitive to short-term treatment effects of donepezil, while global and other domain-specific cognitive measures are not. This longitudinal, randomized, double-blind, placebo-controlled pilot trial (ClinicalTrials.gov Identifier: NCT03073876) evaluated 23 participants newly diagnosed with AD initiating de novo donepezil treatment (5 mg). After baseline assessment, participants were randomized into Drug (n = 12) or Placebo (n = 11) groups, and retested after approximately 6 weeks. Cognitive assessment included: (a) attention tasks (Foreperiod Effect, Attentional Blink, and Covert Orienting tasks) measuring processing speed, top-down accuracy, orienting, intra-individual variability, and fatigue; (b) global measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental Status Examination, Dementia Rating Scale); and (c) domain-specific measures (memory, language, visuospatial, and executive function). The Drug but not the Placebo group showed benefits of treatment at high-load measures by preserving top-down accuracy, improving intra-individual variability, and averting fatigue. In contrast, other global or cognitive domain-specific measures could not detect treatment effects over the same treatment interval. The pilot-study suggests that attention measures targeting accuracy, variability, and fatigue under high-load conditions could be sensitive to short-term cholinergic treatment. Given the central role of acetylcholine in attentional function, load-dependent attentional measures may be valuable cognitive markers of early treatment response.

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

Science.gov (United States)

Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

2013-08-19

Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Andrew M. Busch

2017-04-01

Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

Science.gov (United States)

Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

2017-02-01

Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ 2 1  = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average

Web-Based Intervention for Nutritional Management in Cystic Fibrosis: Development, Usability, and Pilot Trial.

Science.gov (United States)

Stark, Lori J; Opipari-Arrigan, Lisa; Filigno, Stephanie S; Simon, Stacey L; Leonard, Amanda; Mogayzel, Peter J; Rausch, Joseph; Zion, Cynthia; Powers, Scott W

2016-06-01

Usability and pilot testing of a web intervention (BeInCharge.org [BIC]) of behavior plus nutrition intervention for children with cystic fibrosis (CF) ages 4-9 years. Think Aloud methodology was used with five mothers to assess usability and refine the intervention. A pilot trial was then conducted with 10 mothers of children with CF ages 4-9 years randomized to the web-based BIC or a Standard Care Control (STC). Change in weight gain for each group was compared in a pre-to-post design. Mothers rated the usability and clarity of BIC highly. The pilot trial showed children of mothers who received BIC had a significant change in weight pre-to-post-treatment (0.67 kg, p = .04). Change for the STC was not significant (0.41 kg, p = .10). A web-based behavior plus nutrition intervention appears promising in increasing weight gain in children with CF. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

Science.gov (United States)

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

Cupping for treating neck pain in video display terminal (VDT) users: a randomized controlled pilot trial.

Science.gov (United States)

Kim, Tae-Hun; Kang, Jung Won; Kim, Kun Hyung; Lee, Min Hee; Kim, Jung Eun; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon Eui

2012-01-01

This was a randomized controlled pilot trial to evaluate the effectiveness of cupping therapy for neck pain in video display terminal (VDT) workers. Forty VDT workers with moderate to severe neck pain were recruited from May, 2011 to February, 2012. Participants were randomly allocated into one of the two interventions: 6 sessions of wet and dry cupping or heating pad application. The participants were offered an exercise program to perform during the participation period. A 0 to 100 numeric rating scale (NRS) for neck pain, measure yourself medical outcome profile 2 score (MYMOP2 score), cervical spine range of motion (C-spine ROM), neck disability index (NDI), the EuroQol health index (EQ-5D), short form stress response inventory (SRI-SF) and fatigue severity scale (FSS) were assessed at several points during a 7-week period. Compared with a heating pad, cupping was more effective in improving pain (adjusted NRS difference: -1.29 [95% CI -1.61, -0.97] at 3 weeks (p=0.025) and -1.16 [-1.48, -0.84] at 7 weeks (p=0.005)), neck function (adjusted NDI difference: -0.79 [-1.11, -0.47] at 3 (p=0.0039) and 7 weeks (pcupping and 0.91 [0.86, 0.91] with heating pad treatment, p=0.0054). Four participants reported mild adverse events of cupping. Two weeks of cupping therapy and an exercise program may be effective in reducing pain and improving neck function in VDT workers.

The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

DEFF Research Database (Denmark)

Pontoppidan, Maiken W.

2015-01-01

support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

Science.gov (United States)

Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

2015-11-01

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

Science.gov (United States)

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

Melodic intonation therapy in chronic aphasia: Evidence from a pilot randomized controlled trial

NARCIS (Netherlands)

I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)

2016-01-01

textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia.

Science.gov (United States)

Brown, Kirk Warren; Coogle, Constance L; Wegelin, Jacob

2016-11-01

The majority of care for those with Alzheimer's disease and other age-related dementias is provided in the home by family members. To date, there is no consistently effective intervention for reducing the significant stress burden of many family caregivers. The present pilot randomized controlled trial tested the efficacy of an adapted, eight-week mindfulness-based stress reduction (MBSR) program, relative to a near structurally equivalent, standard social support (SS) control condition for reducing caregiver stress and enhancing the care giver-recipient relationship. Thirty-eight family caregivers were randomized to MBSR or SS, with measures of diurnal salivary cortisol, and perceived stress, mental health, experiential avoidance, caregiver burden, and relationship quality collected pre- and post-intervention and at three-month follow-up. MBSR participants reported significantly lower levels of perceived stress and mood disturbance at post-intervention relative to SS participants. At three-month follow-up, participants in both treatment conditions reported improvements on several psychosocial outcomes. At follow-up, there were no condition differences on these outcomes, nor did MBSR and SS participants differ in diurnal cortisol response change over the course of the study. Both MBSR and SS showed stress reduction effects, and MBSR showed no sustained neuroendocrine and psychosocial advantages over SS. The lack of treatment condition differences could be attributable to active ingredients in both interventions, and to population-specific and design factors.

Body composition influenced by progressive elastic band resistance exercise of sarcopenic obesity elderly women: a pilot randomized controlled trial.

Science.gov (United States)

Huang, Shih-Wei; Ku, Jan-Wen; Lin, Li-Fong; Liao, Chun-De; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-08-01

Sarcopenia involves age-related decreases in muscle strength and muscle mass, leading to frailty and disability in elderly people. When combined with obesity, it is defined as sarcopenic obesity (SO), which can result in more functional limitations and metabolic disorders than either disorder alone. The aim of this study was to investigate body composition changes after elastic band resistance training in elderly women with SO. Randomized single-blinded (assessor blinded) controlled pilot trial. Academic medical center. Thirty-five elderly (>60 years old) women with SO. This pilot randomized controlled trial focused on elderly women with SO. The study group underwent progressive elastic band resistance training for 12 weeks (3 times per week). The control group received only a 40-minute lesson about the exercise concept. Dual-energy X-ray absorptiometry was performed before and after intervention to evaluate body composition. Mann-Whitney U and Wilcoxon signed rank tests were used to analyze the differences within and between these groups. In total, 35 elderly women with SO were enrolled and divided into study (N.=18) and control groups (N.=17). No difference was observed in age, biochemical parameters, or Body Mass Index between both groups. After the intervention, the fat proportion of body composition in the right upper extremity (P=0.03), left upper extremity (P=0.04), total fat (P=0.035), and fat percentage (P=0.012) had decreased, and bone mineral density (BMD) (P=0.026), T-score (P=0.028), and Z-score (P=0.021) had increased in the study group. Besides, statistical difference was observed in outcome measurements of right upper extremity (P=0.013), total fat (P=0.023), and fat percentage (P=0.012) between the groups. Our study demonstrated that progressive elastic band resistance exercise can reduce fat mass and increase BMD in elderly women with SO, and that this exercise program is feasible for this demographic. Additional studies with larger sample sizes

Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

Science.gov (United States)

White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

2013-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…

Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Kim Yoon-Bum

2011-03-01

Full Text Available Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE, and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. Methods/Design A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL, KRTE only group (KO, acupuncture only group (AO, and KRTE and acupuncture combined treatment group (KA. After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS and investigator global assessment (IGA from baseline to the end of the trial. Trial Registration The trial is registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000071.

SMS text message reminders to improve infant vaccination coverage in Guatemala: A pilot randomized controlled trial.

Science.gov (United States)

Domek, Gretchen J; Contreras-Roldan, Ingrid L; O'Leary, Sean T; Bull, Sheana; Furniss, Anna; Kempe, Allison; Asturias, Edwin J

2016-05-05

Patient reminder systems are an evidence-based way to improve childhood vaccination rates but are difficult to implement in low- and middle-income countries (LMICs). Short Message Service (SMS) texts may offer a potential low-cost solution, especially in LMICs where mobile phones are becoming more ubiquitous. To determine if an SMS-based vaccination reminder system aimed at improving completion of the infant primary immunization series is feasible and acceptable in Guatemala. A pilot randomized controlled trial was conducted at two public health clinics in Guatemala City. Infants aged 8-14 weeks presenting for the first dose of the primary immunization series were enrolled in March-April 2013. Participants randomized into the intervention received three SMS reminders one week before the second and third dose. A follow-up acceptability survey was administered to both groups. The participation rate was 86.8% (321/370); 8 did not own a cell phone and 12 could not use SMS. 96.9% of intervention parents were sent at least one SMS reminder prior to visit 2 and 96.3% prior to visit 3. Both intervention and usual care participants had high rates of vaccine and visit completion, with a non-statistically significant higher percentage of children in the intervention completing both visit 2 (95.0% vs. 90.1%, p=.12) and visit 3 (84.4% vs. 80.7%, p=.69). More intervention vs. usual care parents agreed that SMS reminders would be helpful for remembering appointments (p<.0001), agreed to being interested in receiving future SMS reminders (p<.0001), and said that they would be willing to pay for future SMS reminders (p=.01). This proof of concept evaluation showed that a new application of SMS technology is feasible to implement in a LMIC with high user satisfaction. Larger studies with modifications in the SMS system are needed to determine effectiveness (Clinical Trial Registry NCT01663636). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial.

Science.gov (United States)

Almufleh, Balqees; Emami, Elham; Alageel, Omar; de Melo, Fabiana; Seng, Francois; Caron, Eric; Nader, Samer Abi; Al-Hashedi, Ashwaq; Albuquerque, Rubens; Feine, Jocelyne; Tamimi, Faleh

2018-04-01

Clinical data regarding newly introduced laser-sintered removable partial dentures (RPDs) are needed before this technique can be recommended. Currently, only a few clinical reports have been published, with no clinical studies. This clinical trial compared short-term satisfaction in patients wearing RPDs fabricated with conventional or computer-aided design and computer-aided manufacturing (CAD-CAM) laser-sintering technology. Twelve participants with partial edentulism were enrolled in this pilot crossover double-blinded clinical trial. Participants were randomly assigned to wear cast or CAD-CAM laser-sintered RPDs for alternate periods of 30 days. The outcome of interest was patient satisfaction as measured using the McGill Denture Satisfaction Instrument. Assessments was conducted at 1, 2, and 4 weeks. The participant's preference in regard to the type of prosthesis was assessed at the final evaluation. The linear mixed effects regression models for repeated measures were used to analyze the data, using the intention-to-treat principle. To assess the robustness of potential, incomplete adherence, sensitivity analyses were conducted. Statistically significant differences were found in patients' satisfaction between the 2 methods of RPD fabrication. Participants were significantly more satisfied with laser-sintered prostheses than cast prostheses in regard to general satisfaction, ability to speak, ability to clean, comfort, ability to masticate, masticatory efficiency, and oral condition (Premovable partial dentures may lead to better outcomes in terms of patient satisfaction in the short term. The conclusion from this pilot study requires confirmation by a larger randomized controlled trial. ClinicalTrials.gov. A study about patient satisfaction with laser-sintered removable partial dentures; NCT02769715. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Kuskowski Michael A

2008-02-01

Full Text Available Abstract Background This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee. Methods Subjects (n = 70 with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a Glucosamine sulfate (1500 mg/d; (b Aquamin (2400 mg/d; (c Combined treatment composed of Glucosamine sulfate (1500 mg/d plus Aquamin (2400 mg/d and (d Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD. Laboratory based blood tests were used as safety measures. Results Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA; however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA. Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7% and 56 feet (+3.5% extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups. Conclusion This small preliminary study suggested that a multi mineral supplement (Aquamin may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and

Relaxation Therapy and Anxiety, Self-Esteem, and Emotional Regulation among Adults with Intellectual Disabilities: A Randomized Controlled Trial

Science.gov (United States)

Bouvet, Cyrille; Coulet, Aurélie

2016-01-01

This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who…

ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.

Science.gov (United States)

Kim, Min Jeong; Tsinalis, Dimitrios; Franz, Stefan; Binet, Isabelle; Gürke, Lorenz; Mihatsch, Michael J; Steiger, Jürg; Thiel, Gilbert; Dickenmann, Michael

2008-01-01

Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible. Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group. The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient. In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

NARCIS (Netherlands)

Kessels, R.P.C.; Hensken, L.M.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

NARCIS (Netherlands)

Kessels, R.P.C.; Olde Hensken, L.M.G.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Chan AW

2017-01-01

Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR Purpose: To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. Patients and methods: “Hidden elderly” is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24 and standard care control (n=24 groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. Results: The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale (B=-1.32, 95% confidence interval [CI] -2.54 to -0.11, P=0.033 and the satisfaction component of the social support questionnaire (B=3.43, 95% CI 0.10–6.76, P=0.044 than the control group. Conclusion: The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

Science.gov (United States)

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie

2017-01-01

Background Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

Science.gov (United States)

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

Science.gov (United States)

Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

2017-08-01

The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial

Directory of Open Access Journals (Sweden)

Bernardete Weber

2012-12-01

Full Text Available OBJECTIVE: To evaluate the effectiveness of the Brazilian Cardioprotective Diet Program in reducing blood pressures, fasting glucose levels and body mass indices in patients with established atherothrombotic disease. METHOD: This randomized controlled pilot trial included outpatients who were over 45 years of age with atherothrombotic cardiovascular disease. Group A, who received the Brazilian Cardioprotective Diet Program, had weekly sessions with dietitians. Groups B and C received the usual dietary therapy that is given to patients with cardiovascular diseases as proposed by the Brazilian guidelines. This diet had the same nutrient profile as that given to Group A, but it was customized by the integration of typical Mediterranean foods. The difference between Groups B and C was the number of sessions with the dietitian. Group B received weekly sessions, while group C only had monthly sessions. ClinicalTrials.gov: NCT 01453166. RESULTS: There was a greater reduction in systolic (7.8% and diastolic (10.8% blood pressures in Group A compared with Group B (2.3% and 7.3%, and Group C (3.9% and 4.9%, respectively. Fasting glucose decreased by 5.3% and 2% in Groups A and B, respectively. Fasting glucose increased by 3.7% in Group C. The BMIs decreased by 3.5% and 3.3% in Groups A and B, respectively. Group C did not present with any changes in BMI. However, none of these data showed statistical differences between the groups, which is methodologically acceptable in pilot trials. CONCLUSIONS: The Brazilian Cardioprotective Diet Program seems to be more effective in reducing blood pressures, fasting glucose levels, weights and BMIs in patients with previous cardiovascular disease compared with the diet that has been proposed by the Brazilian guidelines.

Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

Science.gov (United States)

Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

2013-01-01

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

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

Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.

Science.gov (United States)

Paramasivan, S; Rogers, C A; Welbourn, R; Byrne, J P; Salter, N; Mahon, D; Noble, H; Kelly, J; Mazza, G; Whybrow, P; Andrews, R C; Wilson, C; Blazeby, J M; Donovan, J L

2017-11-01

Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

Science.gov (United States)

Toth, Maria; Marcantonio, Edward R; Davis, Roger B; Walton, Tracy; Kahn, Janet R; Phillips, Russell S

2013-07-01

The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

Science.gov (United States)

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p Home patients were more physically active (median minutes, 209 vs. 78; p home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Efficacy of an educational manual for childbirth companions: pilot study of a randomized clinical trial

Directory of Open Access Journals (Sweden)

Liana Mara Rocha Teles

2018-05-01

Full Text Available ABSTRACT Objective: to evaluate the effectiveness of an educational manual in the instrumentalization of companions to provide support to the parturients and check its influence on the satisfaction of companions and women during vaginal delivery. Method: pilot study of a randomized controlled clinical trial with 65 companions and puerperal women (intervention = 21 and control = 44. The previous knowledge of the companions was evaluated at baseline. The Evaluation Form for Companions in the Delivery Room was used to measure the actions provided and the satisfaction with the experience, and the Questionnaire for Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery was used to evaluate the satisfaction of women with childbirth. The Student’s t-test or Wilcoxon, chi-square or Fisher’s exact test, risk ratios and 95% confidence intervals were used. Results: the companions in the intervention group performed a greater number of support actions (7.2 vs 4.6, p: 0.001 and had higher satisfaction scores (72.4 vs 64.2; p = 0.00. Puerperal women in the intervention group had higher satisfaction with childbirth (119.6 vs 107.9; p: 0.000. Conclusion: the manual was effective for the instrumentalization of companions, contributed to support actions to the parturients and had repercussions on the satisfaction of companions and women with the birthing process. RBR-776d9s

The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial

Directory of Open Access Journals (Sweden)

Park Ji-Eun

2011-12-01

Full Text Available Abstract Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy deficiency or qi excess syndrome were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS and the constipation assessment scale (CAS. Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78, -1.22 (95% CI: -2.7, 0.26, p = 0.1, 0.91 (95% CI: -1.46, 3.28, p = 0.44 in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06 and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15 after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03. Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168

Neuroimaging Correlates of Post-Stroke Aphasia Rehabilitation in a Pilot Randomized Trial of Constraint-Induced Aphasia Therapy.

Science.gov (United States)

Nenert, Rodolphe; Allendorfer, Jane B; Martin, Amber M; Banks, Christi; Ball, Angel; Vannest, Jennifer; Dietz, Aimee R; Szaflarski, Jerzy P

2017-07-18

BACKGROUND Recovery from post-stroke aphasia is a long and complex process with an uncertain outcome. Various interventions have been proposed to augment the recovery, including constraint-induced aphasia therapy (CIAT). CIAT has been applied to patients suffering from post-stroke aphasia in several unblinded studies to show mild-to-moderate linguistic gains. The aim of the present study was to evaluate the neuroimaging correlates of CIAT in patients with chronic aphasia related to left middle cerebral artery stroke. MATERIAL AND METHODS Out of 24 patients recruited in a pilot randomized blinded trial of CIAT, 19 patients received fMRI of language. Eleven of them received CIAT (trained) and eight served as a control group (untrained). Each patient participated in three fMRI sessions (before training, after training, and 3 months later) that included semantic decision and verb generation fMRI tasks, and a battery of language tests. Matching healthy control participants were also included (N=38; matching based on age, handedness, and sex). RESULTS Language testing showed significantly improved performance on Boston Naming Test (BNT; paphasia with no specific effect from CIAT training.

Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

Science.gov (United States)

Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard

2018-01-01

The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

Trial of early noninvasive ventilation for ALS: A pilot placebo-controlled study.

Science.gov (United States)

Jacobs, Teresa L; Brown, Devin L; Baek, Jonggyu; Migda, Erin M; Funckes, Timothy; Gruis, Kirsten L

2016-11-01

To evaluate the use and tolerability of noninvasive positive pressure ventilation (NIV) in patients with amyotrophic lateral sclerosis (ALS) early in their disease by comparing active NIV and sham NIV in patients not yet eligible for NIV use as recommended by practice guidelines. This was a single-center, prospective, double-blind, randomized, placebo (sham)-controlled pilot trial. Patients with ALS were randomized to receive either sham NIV or active NIV and underwent active surveillance approximately every 3 months until they reached a forced vital capacity (FVC) NIV for clinical symptom management. In total, 54 participants were randomized. The mean NIV use was 2.0 hours (95% confidence interval [CI] 1.1-3.0) per day in the sham NIV treatment group and 3.3 hours (CI 2.0-4.6) per day in the active NIV group, which did not differ by treatment group (p = 0.347). The majority of sham NIV participants (88%) and active NIV participants (73%) reported only mild or no problem with NIV use. Difference of change in FVC through the treatment period by group (0.44 per month) favored active NIV (p = 0.049). Survival and changes in maximal inspiratory or expiratory pressure did not differ between treatment groups. The efficacy of early NIV in ALS should be tested in randomized, placebo-controlled trials. The trial is registered on clinicaltrials.gov (NCT00580593). This study provides Class II evidence that for patients with ALS, adherence with NIV and sham NIV are similar. © 2016 American Academy of Neurology.

The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

Science.gov (United States)

Grubbs, Vanessa; Garcia, Faviola; Jue, Bonnie L; Vittinghoff, Eric; Ryder, Mark; Lovett, David; Carrillo, Jacqueline; Offenbacher, Steven; Ganz, Peter; Bibbins-Domingo, Kirsten; Powe, Neil R

2017-02-01

Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials. Copyright © 2016. Published by Elsevier Inc.

A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

Science.gov (United States)

Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

2015-12-01

Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. We included 142 of 231 protocols in the final analysis (concept=78; ad hoc=64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval=0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p=0.67). The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application. © The Author(s) 2015.

The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

Science.gov (United States)

Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

2018-04-01

Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

Science.gov (United States)

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial.

Science.gov (United States)

Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

2013-07-18

The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. The result

Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

Directory of Open Access Journals (Sweden)

Sudha Prathikanti

Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.

Science.gov (United States)

DeZern, Amy E; Williams, Katherine; Zahurak, Marianna; Hand, Wesley; Stephens, R Scott; King, Karen E; Frank, Steven M; Ness, Paul M

2016-07-01

Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused. Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms. This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting. © 2016 AABB.

Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial

NARCIS (Netherlands)

Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

OBJECTIVES: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). METHODS: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys).

Household-based ceramic water filters for the prevention of diarrhea: a randomized, controlled trial of a pilot program in Colombia.

Science.gov (United States)

Clasen, Thomas; Garcia Parra, Gloria; Boisson, Sophie; Collin, Simon

2005-10-01

Household water treatment is increasingly recognized as an effective means of reducing the burden of diarrheal disease among low-income populations without access to safe water. Oxfam GB undertook a pilot project to explore the use of household-based ceramic water filters in three remote communities in Colombia. In a randomized, controlled trial over a period of six months, the filters were associated with a 75.3% reduction in arithmetic mean thermotolerant coliforms (TTCs) (P Health Organization limits for low risk (1-10 TTCs/100 mL), respectively, compared with 0.9% and 7.3% for control group samples. Overall, prevalence of diarrhea was 60% less among households using filters than among control households (odds ratio = 0.40, 95% confidence interval = 0.25, 0.63, P < 0.0001). However, the microbiologic performance and protective effect of the filters was not uniform throughout the study communities, suggesting the need to consider the circumstances of the particular setting before implementing this intervention.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

Science.gov (United States)

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence

Training cognitive flexibility in patients with anorexia nervosa: a pilot randomized controlled trial of cognitive remediation therapy.

Science.gov (United States)

Brockmeyer, Timo; Ingenerf, Katrin; Walther, Stephan; Wild, Beate; Hartmann, Mechthild; Herzog, Wolfgang; Bents, Hinrich; Friederich, Hans-Christoph

2014-01-01

Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group. Copyright © 2013 Wiley Periodicals, Inc.

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

Science.gov (United States)

Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

A pilot randomized controlled trial of EKG for neonatal resuscitation.

Directory of Open Access Journals (Sweden)

Anup Katheria

Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

A Randomized Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Development Disorders

Science.gov (United States)

2015-03-01

hyperactivity disorder, oppositional defiant disorder, schizophrenia, ASD, social anxiety disorder, and major depression ). The child’s appropriateness for...4):958-964. 31. Hardan AY, Fung LK, Libove RA, et al. A randomized controlled pilot trial of oral N- acetylcysteine in children with autism. Biological

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.

Science.gov (United States)

Carpenter, Matthew J; Heckman, Bryan W; Wahlquist, Amy E; Wagener, Theodore L; Goniewicz, Maciej L; Gray, Kevin M; Froeliger, Brett; Cummings, K Michael

2017-12-01

Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking. Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks ( n = 46), or not ( n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents. Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants ( P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not ( P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants. Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors. Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795-803. ©2017 AACR . ©2017 American Association for Cancer Research.

How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial.

Directory of Open Access Journals (Sweden)

Cheryl Carling

Full Text Available BACKGROUND: Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this. METHODS AND FINDINGS: We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD. Participants rated the relative importance of treatment consequences using visual analogue scales (VAS and category rating scales (CRS with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers. We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03. Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51% preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074. However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007. Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins. CONCLUSIONS: Internet-based trials comparing different presentations

Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

Directory of Open Access Journals (Sweden)

Jose M Trigo

Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

Science.gov (United States)

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

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

Using Brothel Leadership to Improve Condom Use among Brothel-based Female Sex Workers in Abuja, Nigeria : Results of a Cluster Randomized Pilot Study

NARCIS (Netherlands)

Okafor, Uchenna O.; Crutzen, Rik; Sylvia, Adebajo; Ifeanyi, Okekearu; Van Den Borne, Bart

2017-01-01

Support by brothel leaders and the promotion of a conducive environment for HIV prevention programs within brothel establishments are important to promote a safe working environment for Brothel-Based Female Sex Workers (BB FSWs). This study assesses the effects of a cluster randomized pilot trial

Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

Science.gov (United States)

Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

2017-11-28

Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

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

Science.gov (United States)

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

2017-08-01

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

Evaluation of internal peer-review to train nurses recruiting to a randomized controlled trial--Internal Peer-review for Recruitment Training in Trials (InterPReTiT).

Science.gov (United States)

Mann, Cindy; Delgado, Debbie; Horwood, Jeremy

2014-04-01

A discussion and qualitative evaluation of the use of peer-review to train nurses and optimize recruitment practice in a randomized controlled trial. Sound recruitment processes are critical to the success of randomized controlled trials. Nurses recruiting to trials must obtain consent for an intervention that is administered for reasons other than anticipated benefit to the patient. This requires not only patients' acquiescence but also evidence that they have weighed the relevant information in reaching their decision. How trial information is explained is vital, but communication and training can be inadequate. A discussion of a new process to train nurses recruiting to a randomized controlled trial. Literature from 1999-2013 about consenting to trials is included. Over 3 months from 2009-2010, recruiting nurses reviewed recruitment interviews recorded during the pilot phase of a single-site randomized controlled trial and noted content, communication style and interactions. They discussed their findings during peer-review meetings, which were audio-recorded and analysed using qualitative methodology. Peer-review can enhance nurses' training in trial recruitment procedures by supporting development of the necessary communication skills, facilitating consistency in information provision and sharing best practice. Nurse-led peer-review can provide a forum to share communication strategies that will elicit and address participant concerns and obtain evidence of participant understanding prior to consent. Comparing practice can improve consistency and accuracy of trial information and facilitate identification of recruitment issues. Internal peer-review was well accepted and promoted team cohesion. Further evaluation is needed. © 2013 John Wiley & Sons Ltd.

Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

Directory of Open Access Journals (Sweden)

Mountain Gail A

2011-01-01

Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

Directory of Open Access Journals (Sweden)

Stoline Michael R

2006-08-01

Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

OpenAIRE

White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

2013-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...

Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

Science.gov (United States)

Viana, R T; Laurentino, G E C; Souza, R J P; Fonseca, J B; Silva Filho, E M; Dias, S N; Teixeira-Salmela, L F; Monte-Silva, K K

2014-01-01

Upper limb (UL) impairment is the most common disabling deficit following a stroke. Previous studies have suggested that transcranial direct current stimulation (tDCS) enhances the effect of conventional therapies. This pilot double-blind randomized control trial aimed to determine whether or not tDCS, combined with Wii virtual reality therapy (VRT), would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals. Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS, or a control group that received VRT and sham tDCS. The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS, and one hour of virtual reality therapy. The outcomes included were determined using the Fugl-Meyer scale, the Wolf motor function test, the modified Ashworth scale (MAS), grip strength, and the stroke specific quality of life scale (SSQOL). Minimal clinically important differences (MCID) were observed when assessing outcome data. Both groups demonstrated gains in all evaluated areas, except for the SSQOL-UL domain. Differences between groups were only observed in wrist spasticity levels in the experimental group, where more than 50% of the participants achieved the MCID. These findings support that tDCS, combined with VRT therapy, should be investigated and clarified further.

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

Science.gov (United States)

Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

2014-04-24

Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

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

Science.gov (United States)

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

2017-10-10

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

Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

Science.gov (United States)

Wong, Virginia C. N.; Kwan, Queenie K.

2010-01-01

We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

Science.gov (United States)

Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

2018-01-01

Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mh

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial

NARCIS (Netherlands)

Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine

2016-01-01

To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year

Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study.

Science.gov (United States)

Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

2014-07-15

To determine the feasibility and pilot a sleep education program in New Zealand high school students. A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. An overall treatment effect was observed for weekend sleep duration (F 1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. A commentary on this article appears in this issue on page 793.

A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Griauzde, Dina H; Kullgren, Jeffrey T; Liestenfeltz, Brad; Richardson, Caroline; Heisler, Michele

2018-01-01

Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience

Mobile access to virtual randomization for investigator-initiated trials.

Science.gov (United States)

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

Science.gov (United States)

2014-01-01

Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a

Are Anti-Stigma Films a Useful Strategy for Reducing Weight Bias Among Trainee Healthcare Professionals? Results of a Pilot Randomized Control Trial

Directory of Open Access Journals (Sweden)

Judy Anne Swift

2013-03-01

Full Text Available Background: Weight bias is an important clinical issue that the educators of tomorrow's healthcare professionals cannot afford to ignore. This study, therefore, aimed to pilot a randomized controlled trial of the effects of educational films designed to reduce weight stigmatization toward obese patients on trainee dietitians' and doctors' attitudes. Methods: A pre-post experimental design with a 6-week follow-up, which consisted of an intervention group (n = 22 and a control group (n = 21, was conducted to assess the efficacy of brief anti-stigma films in reducing weight bias, and to test whether future, larger-scale studies among trainee healthcare professionals are feasible. Results: Participants at baseline demonstrated weight bias, on both implicit and explicit attitude measures, as well as strong beliefs that obesity is under a person's control. The intervention films significantly improved explicit attitudes and beliefs toward obese people, and participant evaluation was very positive. The intervention did not significantly improve implicit anti-fat bias. Conclusion: The current study suggests both that it is possible to conduct a substantive trial of the effects of educational films designed to reduce weight stigma on a larger cohort of trainee healthcare professionals, and that brief educational interventions may be effective in reducing stigmatizing attitudes in this population.

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

John F. Emerson

2015-12-01

Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

The effect of aquatic therapy on postural balance and muscle strength in stroke survivors--a randomized controlled pilot trial.

Science.gov (United States)

Noh, Dong Koog; Lim, Jae-Young; Shin, Hyung-Ik; Paik, Nam-Jong

2008-01-01

To evaluate the effect of an aquatic therapy programme designed to increase balance in stroke survivors. A randomized, controlled pilot trial. Rehabilitation department of a university hospital. Ambulatory chronic stroke patients (n = 25):13 in an aquatic therapy group and 12 in a conventional therapy group. The aquatic therapy group participated in a programme consisting of Ai Chi and Halliwick methods, which focused on balance and weight-bearing exercises. The conventional therapy group performed gym exercises. In both groups, the interventions occurred for 1 hour, three times per week, for eight weeks. The primary outcome measures were Berg Balance Scale score and weight-bearing ability, as measured by vertical ground reaction force during four standing tasks (rising from a chair and weight-shifting forward, backward and laterally). Secondary measures were muscle strength and gait. Compared with the conventional therapy group, the aquatic therapy group attained significant improvements in Berg Balance Scale scores, forward and backward weight-bearing abilities of the affected limbs, and knee flexor strength (P aquatic therapy based on the Halliwick and Ai Chi methods in stroke survivors. Because of limited power and a small population base, further studies with larger sample sizes are required.

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

Science.gov (United States)

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity

DEFF Research Database (Denmark)

Kingston, Jessica; Chadwick, Paul; Meron, Daniel

2007-01-01

Objective: To investigate the effect of mindfulness training on pain tolerance, psychological well-being, physiological activity, and the acquisition of mindfulness skills. Methods: Forty-two asymptomatic University students participated in a randomized, single-blind, active control pilot study. ...

Tailored education for older patients to facilitate engagement in falls prevention strategies after hospital discharge--a pilot randomized controlled trial.

Directory of Open Access Journals (Sweden)

Anne-Marie Hill

Full Text Available BACKGROUND: The aims of the study were to evaluate the effect of providing tailored falls prevention education in hospital on: i engagement in targeted falls prevention behaviors in the month after discharge: ii patients' self-perceived risk and knowledge about falls and falls prevention strategies after receiving the education. METHODS: A pilot randomized controlled trial (n = 50: baseline and outcome assessments conducted by blinded researchers. PARTICIPANTS: hospital inpatients 60 years or older, discharged to the community. Participants were randomized into two groups. The intervention was a tailored education package consisting of multimedia falls prevention information with trained health professional follow-up, delivered in addition to usual care. Outcome measures were engagement in falls prevention behaviors in the month after discharge measured at one month after discharge with a structured survey, and participants' knowledge, confidence and motivation levels before and after receiving the education. The feasibility of providing the intervention was examined and falls outcomes (falls, fall-related injuries were also collected. RESULTS: Forty-eight patients (98% provided follow-up data. The complete package was provided to 21 (84% intervention group participants. Participants in the intervention group were significantly more likely to plan how to safely restart functional activities [Adjusted odds ratio 3.80, 95% CI (1.07, 13.52, p = 0.04] and more likely to complete other targeted behaviors such as completing their own home exercise program [Adjusted odds ratio 2.76, 95% CI (0.72, 10.50, p = 0.14] than the control group. The intervention group was significantly more knowledgeable, confident and motivated to engage in falls prevention strategies after receiving the education than the control group. There were 23 falls (n = 5 intervention; n = 18 control and falls rates were 5.4/1000 patient days (intervention; 18.7/1000 patient days

The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

Directory of Open Access Journals (Sweden)

Scardino Peter T

2009-03-01

Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

Science.gov (United States)

Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

2017-09-01

To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

EMDR for Syrian refugees with posttraumatic stress disorder symptoms:results of a pilot randomized controlled trial

NARCIS (Netherlands)

Acarturk, C.; Konuk, E.; Cetinkaya, M.; Senay, I.; Sijbrandij, M.; Cuijpers, P.; Aker, T.

2015-01-01

Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating

Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus

DEFF Research Database (Denmark)

Simmons, David; Jelsma, Judith G M; Galjaard, Sander

2015-01-01

OBJECTIVE: Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS...

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

2018-01-01

Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited ( n = 12). Subjects were randomly divided into two groups-one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Kay Kulason

2018-03-01

Full Text Available Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA cognitive training in elderly Japanese postsurgical patients.Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited (n = 12. Subjects were randomly divided into two groups—one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J, Frontal Assessment Battery (FAB, computerized Cogstate Brief Battery (CBB] and emotional state [General Health Questionnaire-12 (GHQ-12, Geriatric Depression Scale (GDS, Quality of Life Scale-5 (QOL-5].Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved.Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions.Trial registration: This study was

Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

NARCIS (Netherlands)

Bom, T. van der; Winter, M.M.; Bouma, B.J.; Groenink, M.; Vliegen, H.W.; Pieper, P.G.; Dijk, A.P.J. van; Sieswerda, G.T.; Roos-Hesselink, J.W.; Zwinderman, A.H.; Mulder, B.J.

2013-01-01

BACKGROUND: The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. METHODS AND RESULTS: We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

NARCIS (Netherlands)

van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

2013-01-01

Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial

Science.gov (United States)

Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

2016-01-01

Background Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. Method In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Main Outcome Measures Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. Results We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. Conclusion The results suggest that occupational therapy using the ADOC for older

Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

Science.gov (United States)

van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

2018-01-01

We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

NARCIS (Netherlands)

van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

2013-01-01

The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

Science.gov (United States)

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

2017-08-24

Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly

Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

Science.gov (United States)

Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

2018-02-01

Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial.

Science.gov (United States)

Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K

2007-09-25

To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

Pilot randomized trial of a volitional help sheet-based tool to increase leisure time physical activity in breast cancer survivors.

Science.gov (United States)

Chapman, Janine; Fletcher, Chloe; Flight, Ingrid; Wilson, Carlene

2018-05-16

To develop and test a volitional help sheet-based tool to improve physical activity in breast cancer survivors compared to a standard self-generated implementation intention intervention. Pilot randomized trial conducted online over 3 months. Participants were randomized to an online volitional help sheet (n = 50) or implementation intention (n = 51) intervention. Measures were taken at baseline, 1 and 3 months. The main outcome measure was moderate-strenuous leisure time physical activity. Secondary outcomes were health-related quality of life and mood. Participants exposed to the volitional help sheet and implementation intention interventions showed similar effects after 1 month, with both groups reporting a significant increase in moderate-strenuous physical activity. After 3 months, the initial increase in physical activity was maintained by the volitional help sheet group, but not the implementation intention group. Improvements were also found for negative affect and emotional quality of life. While both interventions show promise in promoting physical activity in breast cancer survivors, the volitional help sheet may be more effective for facilitating lasting change and emotional well-being. Findings suggest that the volitional help sheet may have potential to offer a cost-effective contribution to consumer-led tertiary preventive health. Future research should test these initial findings in a definitive trial. Statement of contribution What is already known on this subject? Physical activity is important for optimizing health in breast cancer survivors. Despite this, physical activity in this cohort remains low. Theory-based strategies are needed to help breast cancer survivors independently manage and maintain regular physical activity over the long term. What does this study add? Online planning interventions can improve physical activity in breast cancer survivors. Volitional help sheets, but not implementation intentions, show sustained

Recruitment barriers in a randomized controlled trial from the physicians' perspective – A postal survey

Directory of Open Access Journals (Sweden)

Karrer Werner

2009-03-01

Full Text Available Abstract Background The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment. Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier to 7 (no agreement with statement = no recruitment barrier. Results 38 of 55 recruiting physicians returned questionnaires (69% response rate, of which 35 could be analyzed (64% useable response rate. Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2–5 had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3–6. Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment. Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be

Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

Science.gov (United States)

Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-06-01

(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (psmindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (psmindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138

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

Directory of Open Access Journals (Sweden)

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

A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study.

Science.gov (United States)

Wozniak, Janet; Faraone, Stephen V; Chan, James; Tarko, Laura; Hernandez, Mariely; Davis, Jacqueline; Woodworth, K Yvonne; Biederman, Joseph

2015-11-01

We conducted a 12-week, randomized, double-blind, controlled clinical trial to evaluate the effectiveness and tolerability of high eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) omega-3 fatty acids and inositol as monotherapy and in combination in children with bipolar spectrum disorders. Participants were children 5-12 years of age meeting DSM-IV diagnostic criteria for bipolar spectrum disorders (bipolar I or II disorder or bipolar disorder not otherwise specified [NOS]) and displaying mixed, manic, or hypomanic symptoms. Subjects with severe illness were excluded. Subjects were randomized to 1 of 3 treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, and the combined active treatment of omega-3 fatty acids plus inositol. Data were collected from February 2012 to November 2013. Twenty-four subjects were exposed to treatment (≥ 1 week of study completed) (inositol [n = 7], omega-3 fatty acids [n = 7], and omega-3 fatty acids plus inositol [n =10]). Fifty-four percent of the subjects completed the study. Subjects randomized to the omega-3 fatty acids plus inositol arm had the largest score decrease comparing improvement from baseline to end point with respect to the Young Mania Rating Scale (P < .05). Similar results were found for the Children's Depression Rating Scale (P < .05) and the Brief Psychiatric Rating Scale (P <.05). Results of this pilot randomized, double-blind, controlled trial suggest that the combined treatment of omega-3 fatty acids plus inositol reduced symptoms of mania and depression in prepubertal children with mild to moderate bipolar spectrum disorders. Results should be interpreted in light of limitations, which include exclusion of severely ill subjects, 54% completion rate, and small sample size. ClinicalTrials.gov identifier: NCT01396486. © Copyright 2015 Physicians Postgraduate Press, Inc.

Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education

Directory of Open Access Journals (Sweden)

Gustavo Saposnik

2017-08-01

Full Text Available BackgroundPhysicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI. Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI.ObjectivesTo evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS.MethodsWe conducted a pilot double-blind, parallel-group, randomized clinical trial. Inclusion criteria included neurologists who are actively involved in managing MS patients. Participants were exposed to 20 simulated case-scenarios (10 cases at baseline, and 10 cases post-randomization to usual care vs. educational intervention of relapsing–remitting MS with moderate or high risk of disease progression. The educational intervention employed a traffic light system (TLS to facilitate decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. We also measured differences between blocks to invoke decision fatigue. The control group responded as they would do in their usual clinical practice not exposed to the educational intervention. The primary feasibility outcome was the proportion of participants who completed the study and the proportion of participants who correctly identified a high-risk case-scenario with the “red traffic light.” Secondary outcomes included decision fatigue (defined as an increment of TI in the second block of case-scenarios compared to the first block and the efficacy of the educational intervention measured as a reduction in TI for MS treatment.ResultsOf 30 neurologists invited to be part of the study, the participation rate was 83.3% (n = 25. Of the 25 participants, 14 were randomly assigned to the control group and 11 to the intervention group. TI was present in 72.0% of participants in at least one case scenario. For the primary feasibility

Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

Science.gov (United States)

Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

2017-08-01

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end

Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

Science.gov (United States)

Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

2017-01-01

An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

Science.gov (United States)

Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

2015-01-01

Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

Science.gov (United States)

Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

2015-01-01

To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP): a randomized trial.

Science.gov (United States)

Landolfi, R; Marchioli, R

1997-01-01

Thrombotic complications characterize the clinical course of polycythemia vera (PV) and represent the main cause of morbidity and mortality. However, uncertainty still exists as to the benefit/risk ratio of aspirin prophylaxis in this setting. In vivo platelet biosynthesis of thromboxane A2 is enhanced and can be suppressed by low-dose aspirin in PV, thus providing a rationale for assessing the efficacy and safety of a low-dose aspirin regimen in these patients. The Gruppo Italiano Studio Policitemia Vera has recently performed a pilot study on 112 patients randomized to receive aspirin, 40 mg daily, or placebo and followed for 16 +/- 6 months (mean +/- SD). This study showed that low-dose aspirin is well tolerated in PV patients, and that a large-scale efficacy trial is feasible in this setting. In this article we report the protocol of the European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP) study, which is a randomized trial designed to assess the risk/benefit ratio of low-dose aspirin in PV. To estimate the size and the follow-up duration required for the ECLAP trial, a retrospective analysis of the clinical epidemiology of a large PV population has recently been completed by the Gruppo Italiano Studio Policitemia Vera. On this basis, approximately 3500 patients will be enrolled in the ECLAP study with a follow-up of 3 to 4 years. The uncertainty principle will be used as the main eligibility criterion: Polycythemic patients of any age, having no clear indication for or contraindication to aspirin treatment, will be randomized in a double-blind fashion to receive oral aspirin (100 mg daily) or placebo. According to current therapeutic recommendations, the basic treatment of randomized patients should be aimed at maintaining the hematocrit value 50. Randomization will be stratified by participating center. The study is funded by the European Union BIOMED 2 program.

Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

Science.gov (United States)

Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

2017-08-01

There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

Early vibration assisted physiotherapy in toddlers with cerebral palsy ? a randomized controlled pilot trial

OpenAIRE

Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

2016-01-01

Objectives: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Methods: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD?3.1); 13 boys). Intervention: 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (?70% adherence) a...

Manual Therapy With Cryotherapy Versus Manual Therapy With Kinesio Taping for Males With Lumbar Discopathy: A Pilot Randomized Trial.

Science.gov (United States)

Lizis, Pawel; Kobza, Wojciech

2017-06-23

Context • Numerous modalities of therapeutic interventions exist for lumbar discopathy. Manual therapy is one option, although its effectiveness remains controversial. The addition of cryotherapy to manual therapy may enhance the health benefits in patients with lumbar discopathy.  Objective • The study intended to evaluate the efficacy of manual therapy combined with cryotherapy vs manual therapy combined with Kinesio taping for males with lumbar discopathy. Design • The research team designed a pilot randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting • The study occurred in the Physiotherapy Outpatient Department of the Regional Hospital (Zywiec, Poland). Participants • The participants were 40 males with lumbar discopathy, aged 30-75 y, who were patients in the department at the hospital. Intervention • The participants were randomly assigned to an intervention group that received Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) combined with cryotherapy, the KEOMT-C group (n = 20), or to a control group that received KEOMT combined with Kinesio taping, the KEOMT-K group (n = 20). The participants in both groups received 10 treatments, 2 per wk for 5 wk. Outcome Measures • The primary outcome was measured using a visual analog scale and the Laitinen scale pain ratings. The secondary outcome measured the quality of life using the short form-36 questionnaire. The participants completed the tests at baseline and postintervention. Results • After the treatments, the intervention group had significantly lower scores than the control group for pain as well as significantly higher scores for quality of life. Conclusions • Patients achieved better health benefits from manual therapy when it was combined with cryotherapy.

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

Directory of Open Access Journals (Sweden)

S.A. Costigan

2015-01-01

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

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

Science.gov (United States)

Costigan, S A; Eather, N; Plotnikoff, R C; Taaffe, D R; Pollock, E; Kennedy, S G; Lubans, D R

2015-01-01

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

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

Science.gov (United States)

Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

2018-01-26

Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

Science.gov (United States)

Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

2016-01-01

Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95�

Effectiveness of school-based humanistic counselling for psychological distress in young people: Pilot randomized controlled trial with follow-up in an ethnically diverse sample.

Science.gov (United States)

Pearce, Peter; Sewell, Ros; Cooper, Mick; Osman, Sarah; Fugard, Andrew J B; Pybis, Joanne

2017-06-01

The aim of this study was to pilot a test of the effectiveness of school-based humanistic counselling (SBHC) in an ethnically diverse group of young people (aged 11-18 years old), with follow-up assessments at 6 and 9 months. Pilot randomized controlled trial, using linear-mixed effect modelling and intention-to-treat analysis to compare changes in levels of psychological distress for participants in SBHC against usual care (UC). ISRCTN44253140. In total, 64 young people were randomized to either SBHC or UC. Participants were aged between 11 and 18 (M = 14.2, SD = 1.8), with 78.1% of a non-white ethnicity. The primary outcome was psychological distress at 6 weeks (mid-therapy), 12 weeks (end of therapy), 6-month follow-up and 9-month follow-up. Secondary measures included emotional symptoms, self-esteem and attainment of personal goals. Recruitment and retention rates for the study were acceptable. Participants in the SBHC condition, as compared with participants in the UC condition, showed greater reductions in psychological distress and emotional symptoms, and greater improvements in self-esteem, over time. However, at follow-up, only emotional symptoms showed significant differences across groups. The study adds to the pool of evidence suggesting that SBHC can be tested and that it brings about short-term reductions in psychological and emotional distress in young people, across ethnicities. However, there is no evidence of longer-term effects. School-based humanistic counselling can be an effective means of reducing the psychological distress experienced by young people with emotional symptoms in the short term. The short-term effectiveness of school-based humanistic counselling is not limited to young people of a White ethnicity. There is no evidence that school-based humanistic counselling has effects beyond the end of therapy. © 2016 The British Psychological Society.

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

Science.gov (United States)

Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

2010-02-01

This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

Cardiorespiratory fitness moderates the effect of an affect-guided physical activity prescription: A pilot randomized controlled trial

NARCIS (Netherlands)

Baldwin, A.S.; Kangas, J.L.; Denman, D.C.; Smits, J.A.J.; Yamada, T.; Otto, M.W.

2016-01-01

Physical activity (PA) interventions have a clear role in promoting mental health. Current PA guidelines directed toward specific PA intensities may have negative effects on affective response to exercise, and affective response is an important determinant of PA adherence. In this randomized trial

A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses.

Science.gov (United States)

Hidderley, Margaret; Holt, Martin

2004-03-01

Autogenic training (AT) is a type of meditation usually used for reducing stress. This pilot study describes how AT was used on a group of early stage cancer patients and the observed effect on stress-related behaviours and immune system responses. This was a randomized trial with 31 early stage breast cancer women, having received a lumpectomy and adjuvant radiotherapy. The women were randomized into two groups. Group 1 received a home visit only. Group 2 received a home visit and 2 months' weekly Autogenic training. At the beginning and end of the 2 monthly periods, the Hospital Anxiety and Depression Scale (HADS) and T and B cell markers were measured to give an indication of changes in immune system responses and measurement of anxiety and depression. At the end of the study, HADS scores and T and B cell markers remained similar in the women who did not receive AT. The women receiving AT showed a strong statistical difference for an improvement in their HADS scores and those women observed in a meditative state as opposed to a relaxed state were found to have an increase in their immune responses. This study suggests AT as a powerful self-help therapy.

Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

Science.gov (United States)

Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

2017-06-01

Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial.

Science.gov (United States)

Ahmed, Sara; Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-12-01

Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI -0.12 to 1.05) and 9 months (mean change 0.39, 95% CI -0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically

Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

Science.gov (United States)

Broadbent, Elizabeth; Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

2018-02-13

Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference -4.53, 95% CI -7.16 to -1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be

Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Voils Corrine I

2012-08-01

Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

Healthy lifestyle promotion in primary schools through the board game Kaledo: a pilot cluster randomized trial.

Science.gov (United States)

Viggiano, Emanuela; Viggiano, Alessandro; Di Costanzo, Anna; Viggiano, Adela; Viggiano, Andrea; Andreozzi, Eleonora; Romano, Vincenzo; Vicidomini, Claudia; Di Tuoro, Daniela; Gargano, Giuliana; Incarnato, Lucia; Fevola, Celeste; Volta, Pietro; Tolomeo, Caterina; Scianni, Giuseppina; Santangelo, Caterina; Apicella, Maria; Battista, Roberta; Raia, Maddalena; Valentino, Ilaria; Palumbo, Marianna; Messina, Giovanni; Messina, Antonietta; Monda, Marcellino; De Luca, Bruno; Amaro, Salvatore

2018-01-20

The board game Kaledo was proven to be effective in improving nutrition knowledge and in modifying dietary behavior in students attending middle and high school. The present pilot study aims to reproduce these results in younger students (7-11 years old) attending primary school. A total of 1313 children from ten schools were recruited to participate in the present study. Participants were randomized into two groups: (1) the treatment group which consisted of playing Kaledo over 20 sessions and (2) the no intervention group. Anthropometric measures were carried out for both groups at baseline (prior to any treatment) and at two follow-up post-assessments (8 and 18 months). All the participants completed a questionnaire concerning physical activity and a 1-week food diary at each assessment. The primary outcomes were (i) BMI z-score, (ii) scores on physical activity, and (iii) scores on a dietary questionnaire. BMI z-score was significantly lower in the treated group compared to the control group at 8 months. Frequency and duration of self-reported physical activity were also significantly augmented in the treated group compared to the control group at both post-assessments. Moreover, a significant increase in the consumption of healthy food and a significant decrease in junk food intake were observed in the treated group. The present results confirm the efficacy of Kaledo in younger students in primary schools, and it can be used as a useful nutritional tool for obesity prevention programs in children. What is Known: • Kaledo is a new educational board game to improve nutrition knowledge and to promote a healthy lifestyle. • In two cluster randomized trials conducted in Campania region (Italy), we showed that Kaledo could improve nutrition knowledge and dietary behavior and have a positive effect on the BMI z-score in children with age ranging from 9 to 14 years old attending school. • Kaledo may be used as an effective tool for obesity prevention

A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

Directory of Open Access Journals (Sweden)

Tamara J. Somers

2016-01-01

Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial

Directory of Open Access Journals (Sweden)

Ambar Kulshreshtha

2010-01-01

Full Text Available Remote monitoring (RM of homebound heart failure (HF patients has previously been shown to reduce hospital admissions. We conducted a pilot trial of ambulatory, non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting. Eligible patients from Massachusetts General Hospital (=150 were randomized to a control group (=68 or to a group that was offered RM (=82. The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study. Participants in the RM program had a lower all-cause per person readmission rate (mean=0.64, SD±0.87 compared to the usual care group (mean=0.73, SD±1.51; -value=.75 although the difference was not statistically significant. HF-related readmission rate was similarly reduced in participants. This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates.

Subgroup Analysis of Trials Is Rarely Easy (SATIRE: a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

Directory of Open Access Journals (Sweden)

Malaga German

2009-11-01

Full Text Available Abstract Background Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1 to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2 to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3 to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. Discussion A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

Science.gov (United States)

Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

2015-10-01

To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

Science.gov (United States)

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final

Effects of a lighter, smaller football on acute match injuries in adolescent female football: a pilot cluster-randomized controlled trial.

Science.gov (United States)

Zebis, Mette K; Thorborg, Kristian; Andersen, Lars L; Møller, Merete; Christensen, Karl B; Clausen, Mikkel B; Hölmich, Per; Wedderkopp, Niels; Andersen, Thomas B; Krustrup, Peter

2018-05-01

The high injury incidence during match-play in female adolescent football is a major concern. In football, males and females play matches with the same football size. No studies have investigated the effect of football size on injury incidence in female adolescent football. Thus, the aim of the present study was to investigate the effects of introducing a lighter, smaller football on the injury pattern in female adolescent football. We conducted a pilot cluster randomized controlled trial including 26 football teams representing 346 adolescent female football players (age 15-18 years). The teams were randomized to a new lighter, smaller football (INT, N.=12 teams) or a traditional FIFA size 5 football (CON, N.=14 teams) during a full match-season. Acute time-loss injuries and football-exposure during match-play were reported weekly by text-message questions and verified subsequently by telephone interview. In total, 46 acute time-loss injuries were registered (5 severe injuries), yielding an incidence rate of 15.2 injuries per 1000 hours of match-play (95% CI: 8.5-27.2) in INT and 18.6 injuries per 1000 hours of match-play (95% CI: 14.0-24.8) in CON. The estimated 22% greater injury incidence rate risk (IRR: 1.22 [95% CI: 0.64-2.35]) in the CON group was not significant. With an IRR of 1.22, a future RCT main study would need to observe 793 acute time-loss injuries during match-play, in order to have a power of 80%. A large-scaled RCT is required to definitively test for beneficial or harmful effects of a lighter, smaller football in adolescent female football.

Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

Science.gov (United States)

Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

2011-01-01

We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

Science.gov (United States)

Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

2017-01-01

Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

A pilot feeding study for adults with asthma: The healthy eating better breathing trial.

Directory of Open Access Journals (Sweden)

Emily P Brigham

Full Text Available Evidence from observational studies and to a lesser extent clinical trials suggest that a healthy diet may improve symptoms and lung function in patients with asthma. We conducted a pilot study to determine the feasibility of conducting a larger scale dietary trial and to provide preliminary evidence on the impact of a healthy diet on asthma outcomes.In a randomized, two period cross-over trial, participants with asthma received a 4-week dietary intervention followed by a usual diet (or vice versa, separated by a 4-week washout. The dietary intervention was a healthy diet rich in unsaturated fat. During the dietary intervention, participants ate three meals per week on site at the Johns Hopkins ProHealth Research Center. All remaining meals and snacks were provided for participants to consume off-site. During the control diet, participants were instructed to continue their usual dietary intake. Relevant biomarkers and asthma clinical outcomes were assessed at 0, 2, and 4 weeks after starting each arm of the study.Eleven participants were randomized, and seven completed the full study protocol. Among these seven participants, average age was 42 years, six were female, and six were African American. Participant self-report of dietary intake revealed significant increases in fruit, vegetable, and omega-3 fatty acid intake with the dietary intervention compared to usual diet. Serum carotenoids (eg. lutein and beta-cryptoxanthin increased in the intervention versus control. Total cholesterol decreased in the intervention versus control diet. There was no consistent effect on asthma outcomes.The findings suggest that a feeding trial in participants with asthma is feasible. Larger trials are needed to definitively assess the potential benefits of dietary interventions on pulmonary symptoms and function in patients with asthma.

Special features of health services and register based trials – experiences from a randomized trial of childbirth classes

Directory of Open Access Journals (Sweden)

Sevón Tiina

2008-06-01

Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health

Topiramate for the management of methamphetamine dependence: a pilot randomized, double-blind, placebo-controlled trial.

Science.gov (United States)

Rezaei, Farzin; Ghaderi, Ebrahim; Mardani, Roya; Hamidi, Seiran; Hassanzadeh, Kambiz

2016-06-01

To date, no medication has been approved as an effective treatment for methamphetamine dependence. Topiramate has attracted considerable attention as a treatment for the dependence on alcohol and stimulants. Therefore, this study aimed to evaluate the effect of topiramate for methamphetamine dependence. This study was a double-blind, randomized, placebo-controlled trial. In the present investigation, 62 methamphetamine-dependent adults were enrolled and randomized into two groups, and received topiramate or a placebo for 10 weeks in escalating doses from 50 mg/day to the target maintenance dose of 200 mg/day. Addiction severity index (ASI) and craving scores were registered every week. The Beck questionnaire was also given to each participant at baseline and every 2 weeks during the treatment. Urine samples were collected at baseline and every 2 weeks during the treatment. Fifty-seven patients completed 10 weeks of the trial. There was no significant difference between both groups in the mean percentage of prescribed capsules taken by the participants. At week six, the topiramate group showed a significantly lower proportion of methamphetamine-positive urine tests in comparison with the placebo group (P = 0.01). In addition, there were significantly lower scores in the topiramate group in comparison with the placebo group in two domains of ASI: drug use severity (P methamphetamine dependence. © 2016 Société Française de Pharmacologie et de Thérapeutique.

Maximizing scientific knowledge from randomized clinical trials

DEFF Research Database (Denmark)

Gustafsson, Finn; Atar, Dan; Pitt, Bertram

2010-01-01

Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Warm ambient temperature decreases food intake in a simulated office setting: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Molly eBernhard

2015-08-01

Full Text Available Background: We hypothesized that exposure to temperatures above the thermoneutral zone would decrease food intake in young adults in a sedentary office environment over a 2-hour period. Methods: Participants wearing standardized clothing were randomized to perform routine office work in either within the thermoneutral zone, considered control (19-20°C, or above the thermoneutral zone considered warmer (26-27°C treatment in parallel-group design (n=11 and 9, respectively. Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, 1st, and 2nd hour during this lunchtime study. Relative heat dissipation was estimated as peripheral temperature. General linear models were conducted to examine the effects of thermal treatment the calories intake and potential mediation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April- May 2014. Results: During the 2 hours stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (P=0.024 in both groups and there was no significant association between calories intake and participant’s BMI. After controlling for thermal treatment, gender and BMI, the participant’s peripheral temperature was significantly associated with calories intake (p=0.002, suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature indicating reduced heat dissipation, participants ate 85.9 kcal less food. Conclusions: This pilot study provided preliminary evidence of effects of thermal environment on food intake and the decreased food intake in the experimental (warmer environment is potentially mediated through thermoregulatory mechanisms.

Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Bernhard, Molly C; Li, Peng; Allison, David B; Gohlke, Julia M

2015-01-01

We hypothesized that exposure to temperatures above the thermoneutral zone (TNZ) would decrease food intake in young adults in a sedentary office environment over a 2-h period. Participants wearing standardized clothing were randomized to perform routine office work in the TNZ, considered control (19-20°C), or above the TNZ considered warmer (26-27°C) using a parallel-group design (n = 11 and 9, respectively). Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, first, and second hour during this lunchtime study. Heat dissipation was estimated using peripheral temperature. General linear models were built to examine the effects of thermal treatment on caloric intake and potential mediation by heat dissipation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April to May 2014. During the 2-h stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (p = 0.024) in both groups and there was no significant association between caloric intake and participant's body mass index (BMI). After controlling for thermal treatment, gender and BMI, the participant's peripheral temperature was significantly associated with caloric intake (p = 0.002), suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature suggesting increased heat dissipation, participants ate 85.9 kcal less food. This pilot study provided preliminary evidence of effects of thermal environment on food intake. It suggests that decreased food intake in the experimental (warmer) environment is potentially mediated through thermoregulatory mechanisms.

Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

Directory of Open Access Journals (Sweden)

Laurier Claudine

2011-01-01

Full Text Available Abstract Background The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care. Methods A pilot clustered randomised trial was conducted. Family medicine groups (FMGs were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program. Results Among 21 FMGs contacted, 5 (24% agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group, and the overall mean level of satisfaction regarding the workshops was 94%. Conclusions This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians

Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial.

Science.gov (United States)

Rickhi, Badri; Kania-Richmond, Ania; Moritz, Sabine; Cohen, Jordan; Paccagnan, Patricia; Dennis, Charlotte; Liu, Mingfu; Malhotra, Sonya; Steele, Patricia; Toews, John

2015-12-24

Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity. A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n = 31) and young adults (ages 19 to 24 years; n = 31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period. At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p = 0.01 at week 16 and p = 0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the

Off-label use of recombinant factor VIIa for treatment of haemorrhage: results from randomized clinical trials

DEFF Research Database (Denmark)

Johansson, Per Ingemar

2008-01-01

) for evidence of such an approach. Methods In October 2007, a review of RCT involving rFVIIa for non-haemophilic indications was performed. The effect of rFVIIa on blood loss and transfusion requirements was recorded. Results Seventeen RCTs were identified concerning different bleeding conditions, for example......, secondary to surgery, infection and stem cell transplantation. Three pilot studies reported a significant reduction in transfusion requirements and/or blood loss in the rFVIIa-treated groups, but these have not been confirmed in large randomized trials. No difference in thromboembolic complications between...

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

OpenAIRE

Eichas Katy; Mandel David R; Holmes Judith

2010-01-01

Abstract Background Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in co...

A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes

OpenAIRE

Richardson, Caroline R; Mehari, Kathleen S; McIntyre, Laura G; Janney, Adrienne W; Fortlage, Laurie A; Sen, Ananda; Strecher, Victor J; Piette, John D

2007-01-01

Abstract Background The majority of individuals with type 2 diabetes do not exercise regularly. Pedometer-based walking interventions can help; however, pedometer-based interventions targeting only total daily accumulated steps might not yield the same health benefits as physical activity programs specifying a minimum duration and intensity of physical activity bouts. Methods This pilot randomized trial compared two goal-setting strategies: 1) lifestyle goals targeting total daily accumulated...

Print versus a culturally-relevant Facebook and text message delivered intervention to promote physical activity in African American women: a randomized pilot trial.

Science.gov (United States)

Joseph, Rodney P; Keller, Colleen; Adams, Marc A; Ainsworth, Barbara E

2015-03-27

African American women report insufficient physical activity and are disproportionally burdened by associated disease conditions; indicating the need for innovative approaches to promote physical activity in this underserved population. Social media platforms (i.e. Facebook) and text messaging represent potential mediums to promote physical activity. This paper reports the results of a randomized pilot trial evaluating a theory-based (Social Cognitive Theory) multi-component intervention using Facebook and text-messages to promote physical activity among African American women. Participants (N = 29) were randomly assigned to receive one of two multi-component physical activity interventions over 8 weeks: a culturally-relevant, Social Cognitive Theory-based, intervention delivered by Facebook and text message (FI) (n = 14), or a non-culturally tailored print-based intervention (PI) (n = 15) consisting of promotion brochures mailed to their home. The primary outcome of physical activity was assessed by ActiGraph GT3X+ accelerometers. Secondary outcomes included self-reported physical activity, physical activity-related psychosocial variables, and participant satisfaction. All randomized participants (N = 29) completed the study. Accelerometer measured physical activity showed that FI participants decreased sedentary time (FI = -74 minutes/week vs. PI = +118 minute/week) and increased light intensity (FI = +95 minutes/week vs. PI = +59 minutes/week) and moderate-lifestyle intensity physical activity (FI = + 27 minutes/week vs. PI = -34 minutes/week) in comparison to PI participants (all P's  .05). Results of secondary outcomes showed that in comparison to the PI, FI participants self-reported greater increases in moderate-to-vigorous physical activity (FI = +62 minutes/week vs. PI = +6 minutes/week; P = .015) and had greater enhancements in self-regulation for physical activity (P program to a friend

Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

Science.gov (United States)

Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

2012-12-14

Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program.

Science.gov (United States)

Murphy, Debra A; Armistead, Lisa; Payne, Diana L; Marelich, William D; Herbeck, Diane M

2017-01-01

A pilot study was conducted to assess the effects of the IMAGE pilot intervention (Improving Mothers' parenting Abilities, Growth, and Effectiveness) on mothers living with HIV (MLH). Based on Fisher and Fisher's IMB model [1992. Changing AIDS risk behavior. Psychological Bulletin, 111, 455-474], the intervention focused on self-care and parenting behavior skills of MLH that affect maternal, child, and family outcomes. A randomized pre-test-post-test two-group design with repeated assessments was used. MLH (n = 62) and their children aged 6-14 (n = 62; total N = 124) were recruited for the trial and randomized to the theory-based skills training condition or a standard care control condition. Assessments were conducted at baseline with follow-ups at 3, 6, and 12 months. Maternal, child, and family outcomes were assessed. Results show significant effects of the intervention for improving parenting practices for mothers. The intervention also improved family outcomes, and showed improvements in the parent-child relationship. IMAGE had a positive impact on parenting behaviors, and on maternal, child, and family outcomes. Given MLH can be challenged by their illness and also live in under-resourced environments, IMAGE may be viewed as a viable way to improve quality of life and family outcomes.

Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

Science.gov (United States)

Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

2011-06-01

To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

Science.gov (United States)

Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

2013-07-02

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the

Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

Directory of Open Access Journals (Sweden)

Ting Joseph

2009-01-01

Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

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

Science.gov (United States)

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

2016-01-01

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

Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

International Nuclear Information System (INIS)

Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

2013-01-01

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

Energy Technology Data Exchange (ETDEWEB)

Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

2013-02-15

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.

Science.gov (United States)

Seo, Jung-Chul; Lee, Hyun-jong; Kwak, Min-Ah; Park, Sung-Hoon; Shin, ImHee; Yun, Woo-Sung; Park, Kihyuk

2014-09-04

Cold hands sensation is a common disorder within the Korean population. Many Korean family physicians believe that it is a mild early manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress, and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands. However, this has not shown a clear benefit, and these medications can cause unwanted side effects. It is also reported that traditional Korean medicine, including acupuncture, is widely used to treat cold hands, although the current level of evidence for this approach is also poor and to date, there have been no published randomized controlled clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold hands. We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial. The proposed study is a five-week pilot RCT. A total of 14 subjects will be recruited and randomly allocated to two groups: an acupuncture plus medication group (experimental group) and a medication-only group (control group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg three times daily) for three weeks. The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks (nine sessions total). The primary outcome will be measured using a visual analogue scale. Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands, frequency and duration of episodes of cold hands, and heart rate variability. Assessments will be made at baseline and at one, three, and five weeks thereafter. This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial. This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the

RTOG: Updated results of randomized trials

International Nuclear Information System (INIS)

Curran, Walter J.

1997-01-01

Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.

Science.gov (United States)

Saposnik, Gustavo; Teasell, Robert; Mamdani, Muhammad; Hall, Judith; McIlroy, William; Cheung, Donna; Thorpe, Kevin E; Cohen, Leonardo G; Bayley, Mark

2010-07-01

Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or "Jenga") among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (P=0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, -14.5, -0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote

Effects of Functional Fascial Taping on pain and function in patients with non-specific low back pain: a pilot randomized controlled trial.

Science.gov (United States)

Chen, Shu-Mei; Alexander, Ron; Lo, Sing Kai; Cook, Jill

2012-10-01

To compare the short-term and medium-term effect of Functional Fascial Taping to placebo taping on pain and function in people with non-specific low back pain. A pilot randomized controlled trial with a 2-week intervention, and 2-, 6- and 12-week follow-up. Individuals with non-specific low back pain recruited from local communities. Forty-three participants with non-specific low back pain for more than 6 weeks were randomized into either Functional Fascial Taping group (n = 21) or placebo group (n = 22). The intervention group was treated with Functional Fascial Taping while the control group was treated with placebo taping. Both groups received four treatments over 2 weeks. Worst and average pain and function were assessed at baseline, after the 2-week intervention, and at 6 and 12 weeks follow-up. The Functional Fascial Taping group demonstrated significantly greater reduction in worst pain compared to placebo group after the 2-week intervention (P = 0.02, effect size = 0.74; 95% confidence interval 0.11-1.34). A higher proportion of participants in Functional Fascial Taping group attained the minimal clinically important difference in worst pain (P = 0.007) and function (P = 0.007) than those in placebo group after the 2-week intervention. There were no significant differences in either group's disability rating or clinically important difference in average pain at any time. Functional Fascial Taping reduced worst pain in patients with non-acute non-specific low back pain during the treatment phase. No medium-term differences in pain or function were observed.

Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol

Directory of Open Access Journals (Sweden)

Costello Anthony

2011-06-01

Full Text Available Abstract Background There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective. Aims Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine: (i The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles (ii The temperature profile of encephalopathic infants with standard care (iii The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome (iv The feasibility of neurodevelopmental follow-up at 18-22 months of age Methods/Design Ethical approval was obtained from Makerere University and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C. Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were

Distant delivery of a mindfulness-based intervention for people with Parkinson's disease: the study protocol of a randomised pilot trial.

Science.gov (United States)

Bogosian, A; Hurt, C S; Vasconcelos E Sa, D; Hindle, J V; McCracken, L; Cubi-Molla, P

2017-01-01

Psychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson's disease. Pharmacological treatments for these conditions appear relatively ineffective in Parkinson's disease. Mindfulness courses are increasingly popular and recognised as effective for managing emotional states, and there is growing evidence for the effectiveness of mindfulness courses for people with long-term medical conditions. With this exploratory pilot trial, we want to assess the feasibility of the procedures and processes, including recruitment, most appropriate outcome measure(s), acceptability of type and number of measures, potential nocebo effects, and potential effectiveness and cost-effectiveness of a specially adapted distance-delivered mindfulness-based intervention in people affected by Parkinson's disease. This is a pilot two-arm randomised parallel group controlled trial. Sixty participants who meet eligibility criteria will be randomly assigned either to an 8-week mindfulness-based intervention group or a wait-list control group. The mindfulness intervention will include 1-h weekly sessions delivered by a health psychologist trained to facilitate mindfulness courses. Participants in both groups will complete standardised questionnaires assessing anxiety, depression, pain, insomnia, fatigue, and daily activities at four time points (baseline, 4, 8, and 20 weeks). The analysis will also consider potential mechanisms of change, such as acceptance, self-compassion, and tolerance of uncertainty, as well as health economic outcomes. Participants' experiences of the mindfulness interventions will be explored via in-depth interviews. A mindfulness-based intervention for people with Parkinson's delivered remotely, through Skype group videoconferences, may represent a viable, more accessible, intervention for people with mobility limitations and people who live in rural areas. The trial will provide important information about the

Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

Science.gov (United States)

Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

2017-02-01

To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( Ppilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.

Science.gov (United States)

Wang, Jingyun; Neely, Daniel E; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G; Kovarik, Jessica; Bowsher, James; Smith, Heather A; Donaldson, Dana; Haider, Kathryn M; Roberts, Gavin J; Sprunger, Derek T; Plager, David A

2016-08-01

To compare the effectiveness of intermittent occlusion therapy (IO therapy) using liquid crystal glasses and continuous occlusion therapy using traditional adhesive patches for treating amblyopia. Children 3-8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled in this randomized controlled trial. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn any optimal refractive correction for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO therapy group with liquid crystal glasses (Amblyz), set at 30-second opaque/transparent intervals (occluded 50% of wear time), and a 2-hour continuous patching group (occluded 100% of wear time). For each patient, visual acuity was measured using ATS-HOTV before and after 12 weeks of treatment. Data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15 ± 0.12 logMAR (95% CI, 0.09-0.15) in the IO therapy group (n = 19) and 0.15 ± 0.11 logMAR (95% CI, 0.1-0.15) in the patching group (n = 15). In both groups improvement was significant, but the difference between groups was not (P = 0.73). No adverse effects were reported. In this pilot study, IO therapy with liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3-8 years of age with moderate amblyopia. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial.

Science.gov (United States)

Reichert, Christoph; Kutschera, Eric; Plötz, Christina; Scharf, Sven; Gölz, Lina; Fimmers, Rolf; Fuhrmann, Christine; Wahl, Gerhard; Braumann, Bert; Jäger, Andreas

2017-09-01

Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.

A New Zealand pilot randomized controlled trial of a web-based interactive self-management programme (MSInvigor8) with and without email support for the treatment of multiple sclerosis fatigue.

Science.gov (United States)

van Kessel, Kirsten; Wouldes, Trecia; Moss-Morris, Rona

2016-05-01

To pilot and compare the efficacy of an internet-based cognitive behavioural therapy self-management programme with (MSInvigor8-Plus) and without (MSInvigor8-Only) the use of email support in reducing fatigue severity and impact (primary outcomes), and depressed and anxious mood (secondary outcomes). Randomized controlled trial using an independent randomization system built into the website and intention-to-treat analysis. Participants were recruited through the local Multiple Sclerosis Society and hospital neurological services in New Zealand. A total of 39 people (aged 31-63 years), experiencing multiple sclerosis fatigue, able to walk with and without walking aids, were randomized to MSInvigor8-Only (n = 20) or to MSInvigor8-Plus (n = 19). MSInvigor8 is an eight-session programme based on cognitive behaviour therapy principles including psycho-education, self-monitoring, and changing unhelpful activity and thought patterns. Outcome measures included fatigue severity (Chalder Fatigue Scale) and impact (Modified Fatigue Impact Scale), and anxiety and depression (Hospital Anxiety and Depression Scale). Assessments were performed at baseline and at 10 weeks. The MSInvigor8-Plus condition resulted in significantly greater reductions in fatigue severity (F [1,36] = 9.09, p multiple sclerosis in New Zealand. © The Author(s) 2015.

The Design of Cluster Randomized Trials with Random Cross-Classifications

Science.gov (United States)

Moerbeek, Mirjam; Safarkhani, Maryam

2018-01-01

Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Levinger, Pazit; Dunn, Jeremy; Bifera, Nancy; Butson, Michael; Elias, George; Hill, Keith D

2017-08-18

The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined. This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA. The results of this study will improve understanding

Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial.

Science.gov (United States)

Gillis, Chelsia; Loiselle, Sarah-Eve; Fiore, Julio F; Awasthi, Rashami; Wykes, Linda; Liberman, A Sender; Stein, Barry; Charlebois, Patrick; Carli, Francesco

2016-05-01

A previous comprehensive prehabilitation program, providing nutrition counseling with whey protein supplementation, exercise, and psychological care, initiated 4 weeks before colorectal surgery for cancer, improved functional capacity before surgery and accelerated functional recovery. Those receiving standard of care deteriorated. The specific role of nutritional prehabilitation alone on functional recovery is unknown. This study was undertaken to estimate the impact of nutrition counseling with whey protein on preoperative functional walking capacity and recovery in patients undergoing colorectal resection for cancer. We conducted a double-blinded randomized controlled trial at a single university-affiliated tertiary center located in Montreal, Quebec, Canada. Colon cancer patients (n=48) awaiting elective surgery for nonmetastatic disease were randomized to receive either individualized nutrition counseling with whey protein supplementation to meet protein needs or individualized nutrition counseling with a nonnutritive placebo. Counseling and supplementation began 4 weeks before surgery and continued for 4 weeks after surgery. The primary outcome was change in functional walking capacity as measured with the 6-minute walk test. The distance was recorded at baseline, the day of surgery, and 4 weeks after surgery. A change of 20 m was considered clinically meaningful. The whey group experienced a mean improvement in functional walking capacity before surgery of +20.8 m, with a standard deviation of 42.6 m, and the placebo group improved by +1.2 (65.5) m (P=0.27). Four weeks after surgery, recovery rates were similar between groups (P=0.81). Clinically meaningful improvements in functional walking capacity were achieved before surgery with whey protein supplementation. These pilot results are encouraging and justify larger-scale trials to define the specific role of nutrition prehabilitation on functional recovery after surgery. Copyright © 2016 Academy of

A Pilot Randomized, Single Blind, Placebo-Controlled Trial of Traditional Acupuncture for Vasomotor Symptoms and Mechanistic Pathways of Menopause

Science.gov (United States)

Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey

2011-01-01

Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial. PMID:21968279

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

Science.gov (United States)

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

2013-03-09

Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task

A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood.

Science.gov (United States)

Roberts, Susan B; Franceschini, Maria Angela; Krauss, Amy; Lin, Pei-Yi; de Sa, Augusto Braima; Có, Raimundo; Taylor, Salima; Brown, Carrie; Chen, Oliver; Johnson, Elizabeth J; Pruzensky, William; Schlossman, Nina; Balé, Carlito; Wu, Kuan-Cheng Tony; Hagan, Katherine; Saltzman, Edward; Muentener, Paul

2017-11-01

Cognitive impairment associated with childhood malnutrition and stunting is generally considered irreversible. The aim was to test a new nutritional supplement for the prevention and treatment of moderate-acute malnutrition (MAM) focused on enhancing cognitive performance. An 11-wk, village-randomized, controlled pilot trial was conducted in 78 children aged 1-3 or 5-7 y living in villages in Guinea-Bissau. The supplement contained 291 kcal/d for young children and 350 kcal/d for older children and included 5 nutrients and 2 flavan-3-ol-rich ingredients not present in current food-based recommendations for MAM. Local bakers prepared the supplement from a combination of locally sourced items and an imported mix of ingredients, and it was administered by community health workers 5 d/wk. The primary outcome was executive function abilities at 11 wk. Secondary outcomes included additional cognitive measures and changes in z scores for weight (weight-for-age) and height (height-for-age) and hemoglobin concentrations at 11 wk. An index of cerebral blood flow (CBF) was also measured at 11 wk to explore the use of this measurement as a biological index of cognitive impairment. There were no significant differences in any outcome between groups at baseline. There was a beneficial effect of random assignment to the supplement group on working memory at 11 wk in children aged 1-3 y ( P < 0.05). This difference contrasted with no effect in older children and was not associated with faster growth rate. In addition, CBF correlated with task-switching performance ( P < 0.05). These preliminary data suggest that cognitive impairment can be monitored with measurement of CBF. In addition, the findings provide preliminary data that suggest that it may be possible to improve poor cognitive performance in young children through changes in the nutritional formulation of supplementary foods used to prevent and treat MAM. Powered studies of the new supplement formulation are needed. This

Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Chan AWK

2016-09-01

Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi, Diana TF Lee, Janet WH Sit, Helen YL Chan The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, People’s Republic of China Purpose: Age-related cognitive decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ on improving the night-time sleep quality of older adults with cognitive impairment. Participants: Older adults with cognitive impairment who complain of sleep disturbance. Methods: A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27 or the control group (n=25. The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results: Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004, sleep duration (P=0.003, habitual sleep efficiency (P=0.002, and the Short-form 12 mental health component (P<0.001. The TCQ participants reported better sleep quality and a better (quality of life mental health component than the control group. Conclusion: TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment.Clinical trial registration: CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287. Keywords: cognitive decline, mind�

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

Science.gov (United States)

2012-01-01

Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

Directory of Open Access Journals (Sweden)

Ashby Rebecca L

2012-07-01

Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

Science.gov (United States)

Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

2017-07-18

The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean

Early skin-to-skin contact after cesarean section: A randomized clinical pilot study.

Directory of Open Access Journals (Sweden)

Martina Kollmann

Full Text Available Early bonding by skin-to-skin contact (SSC has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC after cesarean section on neonatal adaptation, maternal pain and stress response.This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria between September 2013 and January 2014. Women were randomly assigned to intraoperative ("early" SCC (n = 17 versus postoperative ("late" SCC (n = 18. Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature, maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.There was no evidence for differences in parameters reflecting neonatal transition or stress response between the 'Early SSC Group' and the 'Late SSC Group'. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group' (p = 0.004.This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group', which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.ClinicalTrials.gov NCT01894880.

The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

Directory of Open Access Journals (Sweden)

Feazadeh Avraham

2007-01-01

Full Text Available Patello-femoral pain syndrome (PFPS is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y, diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS. Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS; function was assessed by Patello-femoral joint evaluation scale (PFJES (0-100 points. At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001; these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

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

Science.gov (United States)

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

2016-09-13

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

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

Science.gov (United States)

Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

2018-04-01

Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

Science.gov (United States)

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

Directory of Open Access Journals (Sweden)

Kalpana P. Padala

2017-01-01

Full Text Available Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7 years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9 compared to the control group (0.5; 95% CI, −0.3–1.3 at 8 weeks (average intergroup difference (95% CI, 5.5 (4.3–6.7, p < 0.001 after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045.

A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners.

Science.gov (United States)

Milbury, Kathrin; Tsao, Anne S; Liao, Zhongxing; Owns, April; Engle, Rosalinda; Gonzalez, Edrea A; Bruera, Eduardo; Cohen, Lorenzo

2018-01-01

Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design. Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 30% of eligible couples consent, ≥ 70% of enrolled couples are retained, and ≥ 50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial. This trial will provide important information

Biking for Health: Results of a Pilot Randomized Controlled Trial Examining the Impact of a Bicycling Intervention on Lower-Income Adults.

Science.gov (United States)

Bernstein, Rebecca; Schneider, Robert; Welch, Whitney; Dressel, Anne; DeNomie, Melissa; Kusch, Jennifer; Sosa, Mirtha

2017-08-01

This pilot study tested the efficacy of a bicycling intervention targeting inactive, low-income, overweight adults on reducing perceived barriers to bicycling, increasing physical activity, and improving health. A nonblinded 2-site randomized controlled trial was conducted in Milwaukee, Wisconsin, in summer 2015. Participants included members from 1 largely Latino community and a second primarily African American neighborhood. A certified bicycling instructor led a 12-week bicycling intervention. Outcome measures including biking-related attitudes, self-reported physical activity, fitness as measured by the 6-minute step test, and biometric data were collected at baseline, 12 weeks, and 20 weeks. Thirty-eight participants completed the study. Barriers to bicycling declined significantly among intervention group participants at 12 weeks with some declines persisting to 20 weeks. Bicycling for leisure or non work transportation increased significantly more in the intervention than control group from baseline to 12 weeks but this difference attenuated by 20 weeks. Both groups increased their fitness between baseline and 12 weeks, with a trend towards greater gains in the bicycling intervention group. No significant change in biometric measurements was seen at either 12 weeks or 20 weeks. Despite the small study size, this bicycling intervention decreased perceived barriers to bicycling and increased bicycling activity in low-income minority participants. These findings support a larger-scale study to measure fitness and health changes from bicycling interventions.

A Randomized Controlled Pilot Trial of Classroom-Based Mindfulness Meditation Compared to an Active Control Condition in 6th Grade Children

Science.gov (United States)

Britton, Willoughby B.; Lepp, Nathaniel E.; Niles, Halsey F.; Rocha, Tomas; Fisher, Nathan; Gold, Jonathan

2014-01-01

Children in the United States are at risk for numerous psychological problems, such as anxiety, attention problems, and mood disorders, and are underserved by current mental health provisions. The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys and 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported data was collected by administering the Youth Self Report (YSR), a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure -Revised before and after 6 weeks of meditation or active control condition. Both meditators and active controls decreased significantly on the YSR Internalizing Problems, Externalizing Problems, and Attention Problems subscales but did not differ in the extent of their improvements. Both groups also showed comparable improvements on measures in affect. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. Improvements in affect were correlated with increases in mindfulness in meditators but not controls. These results suggest that mindfulness training may yield both unique and nonspecific benefits that are shared by other novel activities. PMID:24930819

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

Science.gov (United States)

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

A 3-Month Randomized Controlled Pilot Trial of a Patient-Centered, Computer-Based Self-Monitoring System for the Care of Type 2 Diabetes Mellitus and Hypertension.

Science.gov (United States)

Or, Calvin; Tao, Da

2016-04-01

This study was performed to evaluate the effects of a patient-centered, tablet computer-based self-monitoring system for chronic disease care. A 3-month randomized controlled pilot trial was conducted to compare the use of a computer-based self-monitoring system in disease self-care (intervention group; n = 33) with a conventional self-monitoring method (control group; n = 30) in patients with type 2 diabetes mellitus and/or hypertension. The system was equipped with a 2-in-1 blood glucose and blood pressure monitor, a reminder feature, and video-based educational materials for the care of the two chronic diseases. The control patients were given only the 2-in-1 monitor for self-monitoring. The outcomes reported here included the glycated hemoglobin (HbA1c) level, fasting blood glucose level, systolic blood pressure, diastolic blood pressure, chronic disease knowledge, and frequency of self-monitoring. The data were collected at baseline and at 1-, 2-, and 3-month follow-up visits. The patients in the intervention group had a significant decrease in mean systolic blood pressure from baseline to 1 month (p computer-assisted and conventional disease self-monitoring appear to be useful to support/maintain blood pressure and diabetes control. The beneficial effects of the use of electronic self-care resources and support provided via mobile technologies require further confirmation in longer-term, larger trials.

Validity of randomized clinical trials in gastroenterology from 1964-2000

DEFF Research Database (Denmark)

Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

2002-01-01

The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial.

Science.gov (United States)

Gilliaux, Maxime; Renders, Anne; Dispa, Delphine; Holvoet, Dominique; Sapin, Julien; Dehez, Bruno; Detrembleur, Christine; Lejeune, Thierry M; Stoquart, Gaëtan

2015-02-01

Several pilot studies have evoked interest in robot-assisted therapy (RAT) in children with cerebral palsy (CP). To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial. Sixteen children with CP were randomized into 2 groups. Eight children performed 5 conventional therapy sessions per week over 8 weeks (control group). Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks (robotic group). For both groups, each therapy session lasted 45 minutes. Throughout each RAT session, the patient attempted to reach several targets consecutively with the REAPlan. The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane. A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework: body structure and function (upper limb kinematics, Box and Block test, Quality of Upper Extremity Skills Test, strength, and spasticity), activities (Abilhand-Kids, Pediatric Evaluation of Disability Inventory), and participation (Life Habits). During each RAT session, patients performed 744 movements on average with the REAPlan. Among the variables assessed, the smoothness of movement (P robotic group than in the control group. This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP. Future studies should investigate the long-term effects of this therapy. © The Author(s) 2014.

Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

DEFF Research Database (Denmark)

Willadsen, Elisabeth

2009-01-01

Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains......-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed...

Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

Science.gov (United States)

Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

2013-02-01

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

Science.gov (United States)

Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

2018-04-01

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial.

Science.gov (United States)

Goertz, Christine M; Salsbury, Stacie A; Long, Cynthia R; Vining, Robert D; Andresen, Andrew A; Hondras, Maria A; Lyons, Kevin J; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2017-10-13

Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care. We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations. At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone. Professional practice models that included primary care and

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

Science.gov (United States)

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Feasibility and acceptability of a nursing intervention with family caregiver on self-care among heart failure patients: a randomized pilot trial.

Science.gov (United States)

Cossette, Sylvie; Belaid, Hayet; Heppell, Sonia; Mailhot, Tanya; Guertin, Marie-Claude

2016-01-01

Self-care practices in heart failure (HF) contribute to quality of life, symptom stabilization, and extended life expectancy. However, adherence to practices such as liquid and salt restriction or symptom monitoring require high motivation on a daily basis. The aim was to assess the feasibility, acceptability, and potential effectiveness of a nursing intervention with family caregivers, aimed at improving self-care practice of HF patients. This pilot study involved 32 HF patient-caregiver dyads (16/group) randomized to an experimental (EG) or control group (CG). The intervention, based on the Self-Determination Theory, was designed to enhance patients' autonomy and motivation in self-care practices, by involving their caregivers' support. Five encounters were planned with the EG dyads-two face-to-face during hospitalization and three by telephone after discharge. The feasibility of delivering the protocol was evaluated as well as the acceptability of the intervention. The potential effectiveness of the intervention was assessed based on patient outcomes, including general self-care management and self-care specific to HF, perceived competence to manage HF, autonomous motivation (A-motivation, external extrinsic motivation, internal extrinsic motivation, and intrinsic motivation), and perceived support from the caregiver. Caregiver outcomes included level of support provided to the patient. Despite recruitment challenges, the intervention was feasible, with 12 of the 16 dyads receiving all 5 encounters delivered per protocol. The 4 other dyads received the two hospital encounters, but at least 1 of the 3 post-discharge planned telephone encounters was not feasible because the patients had been re-hospitalized or was deceased. Participant's satisfaction with the intervention was high. Outcomes favoring the EG include self-care specific to HF, internal extrinsic motivation, intrinsic motivation, and caregiver's feeling that they provide a higher level of support

Using simulation pedagogy to teach clinical education skills: A randomized trial.

Science.gov (United States)

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial.

Science.gov (United States)

Schuster, Corina; Maunz, Gerd; Lutz, Karin; Kischka, Udo; Sturzenegger, Rolf; Ettlin, Thierry

2011-10-01

For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies. To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy. In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention. The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected. In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.

A pilot randomized controlled trial of aerobic exercise as an adjunct to OCD treatment.

Science.gov (United States)

Abrantes, Ana M; Brown, Richard A; Strong, David R; McLaughlin, Nicole; Garnaat, Sarah L; Mancebo, Maria; Riebe, Deborah; Desaulniers, Julie; Yip, Agustin G; Rasmussen, Steven; Greenberg, Benjamin D

2017-11-01

The purpose of the current study was to conduct a randomized controlled trial testing the efficacy of aerobic exercise for decreasing OCD symptom severity, other mental health outcomes, and increasing exercise behaviors and cardiorespiratory fitness among individuals with OCD. Fifty-six patients (64% female; mean age=38.8years) with OCD and a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 16 or greater despite engaging in OCD treatment were randomized to 12-weeks of supervised plus home-based moderate-intensity aerobic exercise (AE; n=28) or to 12-weeks of health education sessions (HE; n=28). Random intercepts mixed models examined differences between conditions at post-treatment. Though no difference between conditions on outcomes was observed, both AE and HE showed significant reduction in OCD symptom severity, depression and anxiety at post-treatment. Relative to HE, significant increases were noted in amount of exercise and cardiorespiratory fitness for those in the AE condition. At post-treatment, 30.4% of the AE condition (7 of 23) were treatment-responders (using the commonly accepted measure of 35% symptom reduction from baseline). In the HE condition, 7.7% of the sample (2 of 26) met this criterion at post-treatment. The results of this preliminary study suggest that exercise and health-focused interventions may be beneficial adjuncts to existing OCD treatment. Future studies with larger samples are needed to more definitively answer questions the efficacy of AE for reducing OCD symptoms and improving related clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

Science.gov (United States)

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly.

Science.gov (United States)

Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

2015-01-01

There is growing evidence that cognitive training (CT) can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG)-based brain-computer interface (BCI) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list control (n=18) arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which was translated and culturally adapted for the Chinese-speaking local population. Users were asked about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants

Effect of tranexamic acid on gross hematuria: A pilot randomized clinical trial study.

Science.gov (United States)

Moharamzadeh, Payman; Ojaghihaghighi, Seyedhossein; Amjadi, Mohsen; Rahmani, Farzad; Farjamnia, Arezoo

2017-12-01

Local forms of the tranexamic acid have been effective in treating many haemorrhagic cases. So that the aim of the current study is to assess the effectiveness of local tranexamic acid in controlling painless hematuria in patients referred to the emergency department. This is a randomized, double-blind clinical trial study, which was conducted on 50 patients with complaints of painless lower urinary tract bleeding during June 2014 and August 2015. The patients were randomly divided into two groups of 25 people each, one group receiving tranexamic acid and the other given a placebo. During bladder irrigation, local tranexamic acid and the placebo were injected into the bladder via Foley catheter. Patients were examined over 24h in terms of the amount of normal saline serum used for irrigation, level of hemoglobin, and blood in urine. In this study it was observed that consumption of tranexamic acid significantly decreased the volume of used serum for bladder irrigation (P=0.041) and the microscopic status of urine decreased significantly in terms of the hematuria after 24h (P=0.026). However, the rate of packed cell transfusion and drop in hemoglobin levels showed no significant difference in both groups of patients (P˃0.05). The results of this study showed that tranexamic acid could significantly reduce the volume of required serum for bladder irrigation to clear urine, but it had no significant effect on the drop in serum hemoglobin levels. Copyright © 2017 Elsevier Inc. All rights reserved.

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

Directory of Open Access Journals (Sweden)

Eichas Katy

2010-01-01

Full Text Available Abstract Background Lactic acid-producing bacteria (LAB probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI, and laboratory tests for erythrocyte sedimentation rate (ESR and C-reactive protein (CRP. Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052 and statistically significant improvement in Pain Scale (P = .046 vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

Science.gov (United States)

2010-01-01

Background Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280 PMID:20067641

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

Directory of Open Access Journals (Sweden)

Sandra M Eldridge

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

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

Science.gov (United States)

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

2016-01-01

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

An 8-week stress management program in pathological gamblers: a pilot randomized controlled trial.

Science.gov (United States)

Linardatou, C; Parios, A; Varvogli, L; Chrousos, G; Darviri, C

2014-09-01

Stress plays a major role at the onset and relapse of pathological gambling (PG), but at the same time it can also be the aftermath of gambling behavior, thus revealing a reciprocal relationship. Although the role of stress has been well-documented, there is a paucity of studies investigating the effect of an adjunctive stress management program on PG. In this 8-week parallel randomized waitlist controlled trial pathological gamblers, already in the gamblers anonymous (GA) group, were assigned randomly in two groups, with the intervention group (n = 22) receiving an additional stress management program (consisting of education on diet and exercise, stress coping methods, relaxation breathing -RB- and progressive muscle relaxation -PMR). Self-reported measures were used in order to evaluate stress, depression, anxiety, sleep quality/disturbances, life-satisfaction and daily routine. The statistical analyses for the between group differences concerning the main psychosocial study outcomes revealed a statistically significant amelioration of stress, depression, anxiety symptoms and an increase of life-satisfaction and a better daily routine in participants of the intervention group. We hope that these will encourage researchers and clinicians to adopt stress management in their future work. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of psychological therapies in randomized trials and practice-based studies.

Science.gov (United States)

Barkham, Michael; Stiles, William B; Connell, Janice; Twigg, Elspeth; Leach, Chris; Lucock, Mike; Mellor-Clark, John; Bower, Peter; King, Michael; Shapiro, David A; Hardy, Gillian E; Greenberg, Leslie; Angus, Lynne

2008-11-01

Randomized trials of the effects of psychological therapies seek internal validity via homogeneous samples and standardized treatment protocols. In contrast, practice-based studies aim for clinical realism and external validity via heterogeneous samples of clients treated under routine practice conditions. We compared indices of treatment effects in these two types of studies. Using published transformation formulas, the Beck Depression Inventory (BDI) scores from five randomized trials of depression (N = 477 clients) were transformed into Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) scores and compared with CORE-OM data collected in four practice-based studies (N = 4,196 clients). Conversely, the practice-based studies' CORE-OM scores were transformed into BDI scores and compared with randomized trial data. Randomized trials showed a modest advantage over practice-based studies in amount of pre-post improvement. This difference was compressed or exaggerated depending on the direction of the transformation but averaged about 12%. There was a similarly sized advantage to randomized trials in rates of reliable and clinically significant improvement (RCSI). The largest difference was yielded by comparisons of effect sizes which suggested an advantage more than twice as large, reflecting narrower pre-treatment distributions in the randomized trials. Outcomes of completed treatments for depression in randomized trials appeared to be modestly greater than those in routine care settings. The size of the difference may be distorted depending on the method for calculating degree of change. Transforming BDI scores into CORE-OM scores and vice versa may be a preferable alternative to effect sizes for comparisons of studies using these measures.

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

Science.gov (United States)

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy

Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

Science.gov (United States)

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-06-01

This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

Standards for reporting randomized controlled trials in neurosurgery.

Science.gov (United States)

Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

2011-02-01

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial.

Science.gov (United States)

Ferraz, Daniel Dominguez; Trippo, Karen Valadares; Duarte, Gabriel Pereira; Neto, Mansueto Gomes; Bernardes Santos, Kionna Oliveira; Filho, Jamary Oliveira

2018-05-01

To compare the effects of functional training, bicycle exercise, and exergaming on walking capacity of elderly with Parkinson disease (PD). A pilot randomized, controlled, single-blinded trial. A state reference health care center for elderly, a public reference outpatient clinic for the elderly. Elderly individuals (≥60 years of age; N=62) with idiopathic PD (stage 2 to 3 of modified Hoehn and Yahr staging scale) according to the London Brain Bank. The participants were randomly assigned to three groups. Group 1 (G1) participated in functional training (n=22); group 2 (G2) performed bicycle exercise (n=20), and group 3 (G3) trained with Kinect Adventures (Microsoft, Redmond, WA) exergames (n=20). The primary outcome measure was the 6-minute walk test (6MWT); secondary outcome measures were the 10-m walk test (10MWT), sitting-rising test (SRT), body mass index, Parkinson Disease Questionnaire-39, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and 15-item Geriatric Depression Scale. All groups showed significant improvements in 6MWT (G1 P=.008; G2 P=.001; G3 P=.005), SRT (G1 Ptraining had similar outcomes compared with functional training and bicycle exercise. The three physical exercise modalities presented significant improvements on walking capacity, ability to stand up and sit, and functionality of the participants. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Supplemental vitamin D and physical performance in COPD: a pilot randomized trial

Directory of Open Access Journals (Sweden)

Bjerk SM

2013-02-01

Full Text Available Sonja M Bjerk,1 Bradley D Edgington,1 Thomas S Rector,1,2 Ken M Kunisaki1,21University of Minnesota, 2Minneapolis VA Health Care System, Minneapolis, MN, USABackground: Low 25-hydroxyvitamin D (25[OH]D levels, commonly observed in chronic obstructive pulmonary disease (COPD, are associated with muscle weakness in elderly populations, and vitamin D supplementation appears to improve muscle strength and decrease falls in older individuals. We tested the effect of vitamin D supplementation on physical performance in patients with COPD.Methods: Patients were randomized to daily cholecalciferol (2000 IU or placebo for 6 weeks. The primary outcome was the 6-week change in Short Physical Performance Battery (SPPB score. Secondary outcomes included changes in the St George’s Respiratory Questionnaire (SGRQ score, and serum 25(OHD.Results: Thirty-six participants (mean age 68 years, all Caucasian males, mean forced expiratory volume in one second 33% of predicted completed the study. Despite an increase in 25(OHD levels in the intervention arm to a mean of 32.6 ng/mL (versus 22.1 ng/mL in the placebo arm, there was no difference in improvements in either SPPB scores (0.3 point difference; 95% confidence interval -0.8 to 1.5; P = 0.56 or SGRQ scores (2.3 point difference; 95% confidence interval -2.3 to 6.9; P = 0.32.Conclusion: Among patients with severe COPD, 2000 IU of daily vitamin D for 6 weeks increased 25(OHD to a level widely considered as normal. However, compared with placebo, short-term vitamin D supplementation had no discernible effect on a simple measure of physical performance.Keywords: chronic obstructive pulmonary disease, randomized controlled trial, vitamin D, skeletal muscle strength

Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

2017-01-26

Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial

Directory of Open Access Journals (Sweden)

Brenner Alison RT

2008-01-01

Full Text Available Abstract Background Decision aids can improve decision making processes, but the amount and type of information that they should attempt to communicate is controversial. We sought to compare, in a pilot randomized trial, two colorectal cancer (CRC screening decision aids that differed in the number of screening options presented. Methods Adults ages 48–75 not currently up to date with screening were recruited from the community and randomized to view one of two versions of our previously tested CRC screening decision aid. The first version included five screening options: fecal occult blood test (FOBT, sigmoidoscopy, a combination of FOBT and sigmoidoscopy, colonoscopy, and barium enema. The second discussed only the two most frequently selected screening options, FOBT and colonoscopy. Main outcomes were differences in screening interest and test preferences between groups after decision aid viewing. Patient test preference was elicited first without any associated out-of-pocket costs (OPC, and then with the following costs: FOBT-$10, sigmoidoscopy-$50, barium enema-$50, and colonoscopy-$200. Results 62 adults participated: 25 viewed the 5-option decision aid, and 37 viewed the 2-option version. Mean age was 54 (range 48–72, 58% were women, 71% were White, 24% African-American; 58% had completed at least a 4-year college degree. Comparing participants that viewed the 5-option version with participants who viewed the 2-option version, there were no differences in screening interest after viewing (1.8 vs. 1.9, t-test p = 0.76. Those viewing the 2-option version were somewhat more likely to choose colonoscopy than those viewing the 5-option version when no out of pocket costs were assumed (68% vs. 46%, p = 0.11, but not when such costs were imposed (41% vs. 42%, p = 1.00. Conclusion The number of screening options available does not appear to have a large effect on interest in colorectal cancer screening. The effect of offering differing

Dose-ranging pilot randomized trial of amino acid mixture combined with physical activity promotion for reducing abdominal fat in overweight adults

Directory of Open Access Journals (Sweden)

Sasai H

2017-07-01

Full Text Available Hiroyuki Sasai,1–3,* Keisuke Ueda,4,5,* Takehiko Tsujimoto,6,7 Hiroyuki Kobayashi,1 Chiaki Sanbongi,4 Shuji Ikegami,4 Yoshio Nakata1 1Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, 2Japan Society for the Promotion of Science, Chiyoda, Tokyo, 3Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Meguro, Tokyo, 4Food Science Research Laboratories, Meiji Co., Ltd., Odawara, Kanagawa, 5Graduate School of Comprehensive Human Sciences, 6Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, 7Faculty of Human Sciences, Shimane University, Matsue, Shimane, Japan *These authors contributed equally to this work Objective: The objective of this study was to determine the effective dose of an amino acid mixture comprising arginine, alanine, and phenylalanine combined with physical activity promotion in reducing abdominal fat among overweight adults.Methods: A 12-week randomized, double-blind, placebo-controlled, dose-ranging, pilot trial was conducted in Mito, Japan, from January through April 2016, and the data were analyzed from May through November 2016. The study participants were 35 overweight adults, aged 20–64 years, with no regular exercise habit. Participants were randomly assigned to high-dose (3,000 mg/d, n=9, medium-dose (1,500 mg/d, n=9, low-dose (750 mg/d, n=8, or placebo (0 mg/d, n=9 groups, and the test beverage containing the amino acid mixture or placebo was administered for 12 weeks. All participants maintained a physically active lifestyle during the study period through monthly physical activity promotion sessions and smartphone-based self-monitoring with wearable trackers. Primary outcomes were changes in abdominal total, subcutaneous, and visceral fat areas, assessed by computed tomography.Results: Of the 35 enrolled participants, 32 completed the 12-week follow-up visit. The intention-to-treat analysis revealed that the changes in abdominal total fat

Pilot trial of a dissonance-based cognitive-behavioral group depression prevention with college students.

Science.gov (United States)

Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M

2016-07-01

Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = 0.64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial.

Science.gov (United States)

Dawson, Jacqueline K; Dorff, Tanya B; Todd Schroeder, E; Lane, Christianne J; Gross, Mitchell E; Dieli-Conwright, Christina M

2018-04-03

Prostate cancer patients on androgen deprivation therapy (ADT) experience adverse effects such as lean mass loss, known as sarcopenia, fat gain, and changes in cardiometabolic factors that increase risk of metabolic syndrome (MetS). Resistance training can increase lean mass, reduce body fat, and improve physical function and quality of life, but no exercise interventions in prostate cancer patients on ADT have concomitantly improved body composition and MetS. This pilot trial investigated 12 weeks of resistance training on body composition and MetS changes in prostate cancer patients on ADT. An exploratory aim examined if a combined approach of training and protein supplementation would elicit greater changes in body composition. Prostate cancer patients on ADT were randomized to resistance training and protein supplementation (TRAINPRO), resistance training (TRAIN), protein supplementation (PRO), or control stretching (STRETCH). Exercise groups (EXE = TRAINPRO, TRAIN) performed supervised exercise 3 days per week for 12 weeks, while non-exercise groups (NoEXE = PRO, STRETCH) performed a home-based stretching program. TRAINPRO and PRO received 50 g⋅day - 1 of whey protein. The primary outcome was change in lean mass assessed through dual energy x-ray absorptiometry. Secondary outcomes examined changes in sarcopenia, assessed through appendicular skeletal mass (ASM) index (kg/m 2 ), body fat %, strength, physical function, quality of life, MetS score and the MetS components of waist circumference, blood pressure, glucose, high-density lipoprotein-cholesterol, and triglyceride levels. A total of 37 participants were randomized; 32 participated in the intervention (EXE n = 13; NoEXE n = 19). At baseline, 43.8% of participants were sarcopenic and 40.6% met the criteria for MetS. Post-intervention, EXE significantly improved lean mass (d = 0.9), sarcopenia prevalence (d = 0.8), body fat % (d = 1.1), strength (d = 0.8-3.0), and

Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial.

Science.gov (United States)

Combs-Miller, Stephanie A; Kalpathi Parameswaran, Anu; Colburn, Dawn; Ertel, Tara; Harmeyer, Amanda; Tucker, Lindsay; Schmid, Arlene A

2014-09-01

To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose (duration/frequency/intensity) on improving walking function, activity, and participation after stroke. Single-blind, pilot randomized controlled trial with three-month follow-up. University and community settings. A convenience sample of participants (N = 20) at least six months post-stroke and able to walk independently were recruited. Thirty-minute walking interventions (body weight-supported treadmill training or overground walking training) were administered five times a week for two weeks. Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity. Walking speed (comfortable/fast 10-meter walk), walking endurance (6-minute walk), spatiotemporal symmetry, and the ICF Measure of Participation and ACTivity were assessed before, immediately after, and three months following the intervention. The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately (change of 0.11 m/s vs. 0.06 m/s, respectively; p = 0.047) and three months (change of 0.14 m/s vs. 0.08 m/s, respectively; p = 0.029) after training. Only the overground walking training group significantly improved comfortable walking speed (p = 0.001), aspects of gait symmetry (p = 0.032), and activity (p = 0.003) immediately after training. Gains were maintained at the three-month follow-up (p training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study. © The Author(s) 2014.

A Randomized Controlled Trial of Simulation-Based Teaching versus Traditional Instruction in Medicine: A Pilot Study among Clinical Medical Students

Science.gov (United States)

Gordon, James A.; Shaffer, David W.; Raemer, Daniel B.; Pawlowski, John; Hurford, William E.; Cooper, Jeffrey B.

2006-01-01

Objective: To compare simulator-based teaching with traditional instruction among clinical medical students. Methods: Randomized controlled trial with written pre-post testing. Third-year medical students (n = 38) received either a myocardial infarction (MI) simulation followed by a reactive airways disease (RAD) lecture, or a RAD simulation…

Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial

Science.gov (United States)

Buford, Thomas W.; Anton, Stephen D.; Bavry, Anthony; Carter, Christy S.; Daniels, Michael J.; Pahor, Marco

2015-01-01

Persons aged over 65 years account for over 75% of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults and declines more rapidly in seniors with hypertension. To date, physical exercise is the primary strategy for attenuating declines in functional status. Yet despite the general benefits of training, exercise alone appears to be insufficient for preventing this decline. Thus, alternative or adjuvant strategies are needed to preserve functional status among seniors with hypertension. Prior data suggest that angiotensin converting enzyme inhibitors (ACEi) may be efficacious in enhancing exercise-derived improvements in functional status yet this hypothesis has not been tested in a randomized controlled trial. The objective of this randomized, double-masked pilot trial is to gather preliminary efficacy and safety data necessary for conducting a full-scale trial to test this hypothesis. Sedentary men and women ≥ 65 years of age with functional limitations and hypertension are being recruited into this 24 week intervention study. Participants are randomly assigned to one of three conditions: (1) ACEi plus exercise training, (2) thiazide diuretic plus exercise training, or (3) AT1 receptor antagonist plus exercise training. The primary outcome is change in walking speed and secondary outcomes consist of other indices of CV risk including exercise capacity, body composition, as well as circulating indices of metabolism, inflammation and oxidative stress. PMID:26115878

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

Science.gov (United States)

Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in

Experimental pain ratings and reactivity of cortisol and soluble tumor necrosis factor-α receptor II following a trial of hypnosis: Results of a randomized controlled pilot study

Science.gov (United States)

Goodin, Burel R.; Quinn, Noel B.; Kronfli, Tarek; King, Christopher D.; Page, Gayle G.; Haythornthwaite, Jennifer A.; Edwards, Robert R.; Stapleton, Laura M.; McGuire, Lynanne

2011-01-01

Objective Current evidence supports the efficacy of hypnosis for reducing the pain associated with experimental stimulation and various acute and chronic conditions; however, the mechanisms explaining how hypnosis exerts its effects remain less clear. The hypothalamic-pituitary-adrenal (HPA) axis and pro-inflammatory cytokines represent potential targets for investigation given their purported roles in the perpetuation of painful conditions; yet, no clinical trials have thus far examined the influence of hypnosis on these mechanisms. Design Healthy participants, highly susceptible to the effects of hypnosis, were randomized to either a hypnosis intervention or a no-intervention control. Using a cold pressor task, assessments of pain intensity and pain unpleasantness were collected prior to the intervention (Pre) and following the intervention (Post) along with pain-provoked changes in salivary cortisol and the soluble receptor of tumor necrosis factor-α (sTNFαRII). Results Compared to the no-intervention control, data analyses revealed that hypnosis significantly reduced pain intensity and pain unpleasantness. Hypnosis was not significantly associated with suppression of cortisol or sTNFαRII reactivity to acute pain from Pre to Post; however, the effect sizes for these associations were medium-sized. Conclusions Overall, the findings from this randomized controlled pilot study support the importance of a future large-scale study on the effects of hypnosis for modulating pain-related changes of the HPA axis and pro-inflammatory cytokines. PMID:22233394

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

Directory of Open Access Journals (Sweden)

Farah Jindani

2015-01-01

Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial.

Science.gov (United States)

Zunza, Moleen; Cotton, Mark F; Mbuagbaw, Lawrence; Lester, Richard; Thabane, Lehana

2017-07-17

South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phone text messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices. A randomized, parallel group, single-center pilot trial. Electronic sequence generation and random allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa will be randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text message plus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria for feasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligible participants consent for study participation, complete evaluation of outcomes in at least 70% of all recruited participants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery. Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysis will follow the "intention-to-treat" principle. Sub-group analysis will be used to assess sub-group effects. This pilot trial will evaluate the feasibility of conducting a larger trial on communication and support approaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivational interviewing are simple interventions which may allow participants to access personalized adherence advice and support. ClinicalTrials.gov: NCT02949713 . Registered on 26 October 2016; Pan African Clinical Trial Registry PACTR201611001855404 . Registered on 8 November 2016.

A pilot trial of a videogame-based exercise program for methadone maintained patients.

Science.gov (United States)

Cutter, Christopher J; Schottenfeld, Richard S; Moore, Brent A; Ball, Samuel A; Beitel, Mark; Savant, Jonathan D; Stults-Kolehmainen, Matthew A; Doucette, Christopher; Barry, Declan T

2014-10-01

Few studies have examined exercise as a substance use disorder treatment. This pilot study investigated the feasibility and acceptability of an exercise intervention comprising the Wii Fit Plus™ and of a time-and-attention sedentary control comprising Wii™ videogames. We also explored their impact on physical activity levels, substance use, and psychological wellness. Twenty-nine methadone-maintained patients enrolled in an 8-week trial were randomly assigned to either Active Game Play (Wii Fit Plus™ videogames involving physical exertion) or Sedentary Game Play (Wii™ videogames played while sitting). Participants had high satisfaction and study completion rates. Active Game Play participants reported greater physical activity outside the intervention than Sedentary Game Play participants despite no such differences at baseline. Substance use decreased and stress and optimism improved in both conditions. Active Game Play is a feasible and acceptable exercise intervention, and Sedentary Game Play is a promising time-and-attention control. Further investigations of these interventions are warranted. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

Directory of Open Access Journals (Sweden)

Guallar Eliseo

2010-12-01

Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial

Directory of Open Access Journals (Sweden)

Kate Fetterplace

2018-02-01

Full Text Available Abstract Background Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. Methods This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein. The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT from baseline (prior to randomisation to ICU discharge and other nutritional and patient-centred outcomes. Discussion This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Trial registration

Brief Report: Pilot Randomized Controlled Trial of Reciprocal Imitation Training for Teaching Elicited and Spontaneous Imitation to Children with Autism

Science.gov (United States)

Ingersoll, Brooke

2010-01-01

Children with autism exhibit significant deficits in imitation skills. Reciprocal Imitation Training (RIT), a naturalistic imitation intervention, was developed to teach young children with autism to imitate during play. This study used a randomized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21…

Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study).

Science.gov (United States)

Burns, K E A; Rizvi, L; Smith, O M; Lee, Y; Lee, J; Wang, M; Brown, M; Parker, M; Premji, A; Leung, D; Hammond Mobilio, M; Gotlib-Conn, L; Nisenbaum, R; Santos, M; Li, Y; Mehta, S

2015-01-01

To assess the feasibility of conducting a randomized trial comparing two strategies [physician (MD) vs. non-physician (non-MD)] for approaching substitute decision makers (SDMs) for research and to evaluate SDMs' experiences in being approached for consent. A pilot mixed methods study of first encounters with SDMs. Of 137 SDMs (162 eligibility events), 67 and 70 were randomized to MD and non-MD introductions, respectively. Eighty SDMs (98 events) provided consent and 21 SDMs (24 events) declined consent for studies, including 2 SDMs who provided and declined consent. We identified few missed introductions [4/52 (7.7 %)] and protocol violations [6/117 (5.1 %)], high comfort, satisfaction and acceptance scores and similar consent rates in both arms. SDMs provided consent significantly more often when a patient update was provided in the MD arm. Most SDMs (85.7 %) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care; however, SDM experiences were closely related to their recall of being approached and recall was poor. SDMs highlighted 7 themes of importance to them in research surrogate decision-making. SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care. A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial, despite achieving all feasibility metrics in the pilot trial. NCT01232621.

Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial.

Science.gov (United States)

Elsas, S M; Gregory, W L; White, G; Navarro, G; Salinsky, M C; Andrews, D J

2011-12-01

Patients with epilepsy frequently experience depression and emotional stress and these may function as seizure triggers in epileptogenic frontotemporal cortex, which serves in emotional processing. Eight patients enrolled in a pilot trial of a 6-month epilepsy-specific behavioral approach comprising counseling and relaxation to recognize and eliminate emotional seizure triggers. Potential participants with psychogenic seizures were excluded by long-term EEG and/or the MMPI profile. One participant became seizure free, another had an approximately 90% reduction in seizures, and two additional participants achieved a greater than 50% reduction in seizure frequency (total responder rate=50%), stable during 6 months of observation after the intervention. All completers showed marked and stable improvement of quality of life (Quality of Life in Epilepsy-89 inventory) and temporary improvement in the Profile of Mood States. An adequately powered randomized controlled trial is needed to confirm our findings, which suggest that behavioral approaches may hold promise for motivated patients with epilepsy. Copyright © 2011 Elsevier Inc. All rights reserved.

A five-day inpatient EMDR treatment programme for PTSD: pilot study

NARCIS (Netherlands)

Zepeda Méndez, Mayaris; Nijdam, Mirjam J.; ter Heide, F. Jackie June; van der Aa, Niels; Olff, Miranda

2018-01-01

Conclusions: The majority of patients in our pilot study experienced symptom reduction consistent with reliable changes in this five-day inpatient treatment with EMDR and yoga. Randomized controlled trials - with longer follow up periods - are needed to properly determine efficacy and efficiency of

Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

Science.gov (United States)

McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

2016-11-01

This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

Pilot trial of an expressive writing intervention with HIV-positive methamphetamine-using men who have sex with men.

Science.gov (United States)

Carrico, Adam W; Nation, Austin; Gómez, Walter; Sundberg, Jeffrey; Dilworth, Samantha E; Johnson, Mallory O; Moskowitz, Judith T; Rose, Carol Dawson

2015-06-01

Among men who have sex with men (MSM), the co-occurrence of trauma and stimulant use has negative implications for HIV/AIDS prevention. HIV-positive, methamphetamine-using MSM were recruited to pilot test a 7-session, multicomponent resilient affective processing (RAP) intervention that included expressive writing exercises targeting HIV-related traumatic stress. An open-phase pilot with 10 participants provided support for feasibility of intervention delivery such that 99% of the RAP sessions were completed in a 1-month period. Subsequently, 23 additional participants were enrolled in a pilot randomized controlled trial of the RAP intervention (n = 12) versus an attention-control condition that included writing exercises about neutral topics (n = 11). Acceptability was evidenced by participants randomized to RAP expressing significantly more negative emotions in their writing and reporting greater likelihood of recommending expressive writing exercises to a friend living with HIV. Over the 3-month follow-up period, attention-control participants reported significant decreases in HIV-related traumatic stress while RAP intervention participants reported no significant changes. Compared to attention-control participants, those in the RAP intervention reported significant reductions in the frequency of methamphetamine use immediately following the 1-month RAP intervention period. Thematic analyses of RAP expressive writing exercises revealed that multiple negative life events characterized by social stigma or loss contribute to the complex nature of HIV-related traumatic stress. Findings support the feasibility and acceptability of an exposure-based intervention targeting HIV-related traumatic stress. However, more intensive intervention approaches that simultaneously target trauma and stimulant use will likely be needed to optimize HIV/AIDS prevention efforts with this population. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Task-Based Mirror Therapy Augmenting Motor Recovery in Poststroke Hemiparesis: A Randomized Controlled Trial.

Science.gov (United States)

Arya, Kamal Narayan; Pandian, Shanta; Kumar, Dharmendra; Puri, Vinod

2015-08-01

To establish the effect of the task-based mirror therapy (TBMT) on the upper limb recovery in stroke. A pilot, randomized, controlled, assessor-blinded trial was conducted in a rehabilitation institute. A convenience sample of 33 poststroke (mean duration, 12.5 months) hemiparetic subjects was randomized into 2 groups (experimental, 17; control, 16). The subjects were allocated to receive either TBMT or standard motor rehabilitation-40 sessions (5/week) for a period of 8 weeks. The TBMT group received movements using various goal-directed tasks and a mirror box. The movements were performed by the less-affected side superimposed on the affected side. The main outcome measures were Brunnstrom recovery stage (BRS) and Fugl-Meyer assessment (FMA)-FMA of upper extremity (FMA-UE), including upper arm (FMA-UA) and wrist-hand (FMA-WH). The TBMT group exhibited highly significant improvement on mean scores of FMA-WH (P hemiparesis. MT using tasks may be used as an adjunct in stroke rehabilitation. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

Science.gov (United States)

White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

2012-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

Science.gov (United States)

Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

2017-09-01

To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial

NARCIS (Netherlands)

Verberk, W. J.; Kroon, A. A.; Kessels, A. G. H.; Nelemans, P. J.; van Ree, J. W.; Lenders, J. W. M.; Thien, T.; Bakx, J. C.; van Montfrans, G. A.; Smit, A. J.; Beltman, F. W.; de Leeuw, P. W.

2005-01-01

Background. Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial.

NARCIS (Netherlands)

Verberk, W.J.; Kroon, A.A.; Kessels, A.G.H.; Nelemans, P.J.; Ree, J.W. van; Lenders, J.W.M.; Thien, Th.; Bakx, J.C.; Montfrans, G.A. van; Smit, A.J.; Beltman, F.W.; Leeuw, P.W. de

2005-01-01

BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial.

Science.gov (United States)

Kim, Mikyung; Choi, Eun-Ji; Kim, Sung-Phil; Kim, Jung-Eun; Park, Hyo-Ju; Kim, Ae-Ran; Seo, Bok-Nam; Kwon, O-Jin; Cho, Jung Hyo; Chung, Sun-Yong; Kim, Joo-Hee

2017-01-13

Major depressive disorder (MDD) is one of the most prevalent mental health disorders and has a significant societal economic burden. Antidepressants and cognitive behavioral therapy are two primary interventions for the standardized treatment of MDD. However, their weaknesses, such as a low response rate, a high risk of adverse events from medication, and the high cost of cognitive behavioral therapy, have resulted in a need for complementary and alternative medicine (CAM). Among the various therapeutic interventions in CAM, electroacupuncture and moxibustion have been widely used to treat various mental illnesses, including MDD. The aim of this study is to evaluate the feasibility of conducting a full-scale randomized controlled trial to investigate the efficacy and safety of electroacupuncture plus moxibustion therapy for MDD. We will include patients between the ages of 19 to 65 years with MDD. A total of 30 participants will be recruited, and they will be randomly allocated into two groups at a 1:1 ratio. Patients in the treatment and control groups will, respectively, receive real and sham electroacupuncture/moxibustion treatments, for a total of 20 sessions over 8 weeks. The primary outcome will be the Hamilton Rating Scale for Depression, and the secondary outcomes will be Beck's Depression Inventory, the Insomnia Severity Index, the State-Trait Anxiety Inventory, the EuroQol 5-Dimension Index, the Measure Yourself Medical Outcome Profile version 2, and electroencephalography. Adverse events will be monitored at each visit to assess safety. All outcomes will be assessed and analyzed by researchers blinded to the treatment allocation. This is a two-armed, parallel-design, patient-assessor blinded, multicenter, randomized, sham-controlled pilot clinical trial. Data will be analyzed before and after treatment and during a 4-week follow-up. The results of the trial will provide a basis for further studies assessing the efficacy and safety of electroacupuncture

Fundamentals of randomized clinical trials in wound care

DEFF Research Database (Denmark)

Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

2012-01-01

randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

Evaluating the Flipped Classroom: A Randomized Controlled Trial

Science.gov (United States)

Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

The Danish randomized lung cancer CT screening trial

DEFF Research Database (Denmark)

Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger

2009-01-01

INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...... lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false......-positive screen results compared with previous studies on lung cancer screening....

Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial

Science.gov (United States)

2013-01-01

Background Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Methods Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flavanol (n = 21) chocolate consumption for 12 weeks. At randomization (0, 60, 120 and 180 min after a single 40-g dose of chocolate), 6 and 12 weeks after daily 20-g chocolate intake, we evaluated plasma concentrations of flavanols and theobromine, as well as the FMD and BP. Results Plasma epicatechin was significantly increased (p chocolate compared to low-flavanol chocolate. Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate (p chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestion Trial registration ClinicalTrials.gov Identifier: NCT01659060 PMID:23565841

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

Science.gov (United States)

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial.

Science.gov (United States)

Best, Krista L; Routhier, François; Sweet, Shane N; Arbour-Nicitopoulos, Kelly P; Borisoff, Jaimie F; Noreau, Luc; Martin Ginis, Kathleen A

2017-04-26

Physical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users. The primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective). A total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals' preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A

Effect of whole-body vibration exercise on mobility, balance ability and general health status in frail elderly patients: a pilot randomized controlled trial.

Science.gov (United States)

Zhang, Li; Weng, Changshui; Liu, Miao; Wang, Qiuhua; Liu, Liming; He, Yao

2014-01-01

To study the effects of whole-body vibration exercises on the mobility function, balance and general health status, and its feasibility as an intervention in frail elderly patients. Pilot randomized controlled trial. Forty-four frail older persons (85.27 ± 3.63 years) meeting the Fried Frailty Criteria. All eligible subjects were randomly assigned to the experimental group, who received a whole-body vibration exercise alone (vibration amplitude: 1-3 mm; frequency: 6-26 Hz; 4-5 bouts × 60 seconds; 3-5 times weekly), or a control group, who received usual care and exercises for eight weeks. The Timed Up and Go Test, 30-second chair stand test, lower extremities muscle strength, balance function, balance confidence and General Health Status were assessed at the beginning of the study, after four weeks and eight weeks of the intervention. Whole-body vibration exercise reduced the time of the Timed Up and Go Test (40.47 ± 15.94 s to 21.34 ± 4.42 s), improved the bilateral knees extensor strength (6.96 ± 1.70 kg to 11.26 ± 2.08 kg), the posture stability (surface area ellipse: 404.58 ± 177.05 to 255.95 ± 107.28) and General Health Status (Short-form Health Survey score: 24.51 ± 10.69 and 49.63 ± 9.85 to 45.03 ± 11.15 and 65.23 ± 9.39, respectively). The repeated-measures ANOVA showed that there were significant differences in the Timed Up and Go Test, 30-second chair stand test, bilateral knees extensor strength, activities-specific balance confidence score and general health status between the two groups (P balance and the general health status in the frail elderly.

The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

William F. Clark

2017-08-01

Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial.

Science.gov (United States)

Mandel, David R; Eichas, Katy; Holmes, Judith

2010-01-12

Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. ACTRN12609000435280.

Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial.

Science.gov (United States)

Huang, Jia; McCaskey, Michael A; Yang, Shanli; Ye, Haicheng; Tao, Jing; Jiang, Cai; Schuster-Amft, Corina; Balzer, Christian; Ettlin, Thierry; Schupp, Wilfried; Kulke, Hartwig; Chen, Lidian

2015-12-02

A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain). An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life. This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and

Self-compassion training for binge eating disorder: a pilot randomized controlled trial.

Science.gov (United States)

Kelly, Allison C; Carter, Jacqueline C

2015-09-01

The present pilot study sought to compare a compassion-focused therapy (CFT)-based self-help intervention for binge eating disorder (BED) to a behaviourally based intervention. Forty-one individuals with BED were randomly assigned to 3 weeks of food planning plus self-compassion exercises; food planning plus behavioural strategies; or a wait-list control condition. Participants completed weekly measures of binge eating and self-compassion; pre- and post-intervention measures of eating disorder pathology and depressive symptoms; and a baseline measure assessing fear of self-compassion. Results showed that: (1) perceived credibility, expectancy, and compliance did not differ between the two interventions; (2) both interventions reduced weekly binge days more than the control condition; (3) the self-compassion intervention reduced global eating disorder pathology, eating concerns, and weight concerns more than the other conditions; (4) the self-compassion intervention increased self-compassion more than the other conditions; and (5) participants low in fear of self-compassion derived significantly more benefits from the self-compassion intervention than those high in fear of self-compassion. Findings offer preliminary support for the usefulness of CFT-based interventions for BED sufferers. Results also suggest that for individuals to benefit from self-compassion training, assessing and lowering fear of self-compassion will be crucial. Individuals with BED perceive self-compassion training self-help interventions, derived from CFT, to be as credible and as likely to help as behaviourally based interventions. The cultivation of self-compassion may be an effective approach for reducing binge eating, and eating, and weight concerns in individuals with BED. Teaching individuals with BED CFT-based self-help exercises may increase their self-compassion levels over a short period of time. It may be important for clinicians to assess and target clients' fear of self

Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

Science.gov (United States)

Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

2017-07-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Gabriel López-Velázquez

2015-10-01

Full Text Available Background: The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin® and Metlos® was demonstrated. Methods: This study aimed to demonstrate the efficacy as prebiotics of Metlin® and Metlos® in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. Results: There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin® and Metlos®. Conclusions: Our results support the efficacy of Metlin® and Metlos® as prebiotics in humans, and stand the bases to recommend their consumption. Trial Registration: ClinicalTrials.gov, NCT 01251783.

Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial.

Science.gov (United States)

Ojha, Shalini; Szatkowski, Lisa; Sinha, Ranjeet; Yaron, Gil; Fogarty, Andrew; Allen, Stephen; Choudhary, Sunil; Smyth, Alan R

2014-07-23

The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women's self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention. We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age. Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There

Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

Science.gov (United States)

Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

2014-10-22

The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on

Practical Implications of Metacognitively Oriented Psychotherapy in Psychosis : Findings From a Pilot Study

NARCIS (Netherlands)

de Jong, Steven; van Donkersgoed, Rozanne J. M.; Aleman, Andre; van der Gaag, Mark; Wunderink, Lex; Arends, Johan; Lysaker, Paul H.; Pijnenborg, Marieke

In preparation for a multicenter randomized controlled trial, a pilot study was conducted investigating the feasibility and acceptance of a shortened version (12 vs. 40 sessions) of an individual metacognitive psychotherapy (Metacognitive Reflection and Insight Therapy [MERIT]). Twelve participants

Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

Directory of Open Access Journals (Sweden)

Benjamin J Cowling

2008-05-01

Full Text Available There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members.We conducted a cluster randomized controlled trial of households (composed of at least 3 members where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1 control or 2 surgical face masks or 3 hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms. We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable.The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008.ClinicalTrials.gov NCT00425893 HKClinicalTrials.com HKCTR-365.

Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

Directory of Open Access Journals (Sweden)

Buck Deborah

2012-10-01

Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

Whole-body vibration training improves balance control and sit-to-stand performance among middle-aged and older adults: a pilot randomized controlled trial

OpenAIRE

Ko, Ming-Chen; Wu, Long-Shan; Lee, Sangwoo; Wang, Chien-Chun; Lee, Po-Fu; Tseng, Ching-Yu; Ho, Chien-Chang

2017-01-01

Background Aging is associated with decreased balance, which increases falling risk. The objective of the current study was to determine the feasibility and effects of whole-body vibration (WBV) training on knee extensor muscle power, limits of stability, and sit-to-stand performance among community-dwelling middle-aged and older adults in the United States. Methods A randomized pilot study with participant blinding was conducted. Feasibility outcomes included recruitment and compliance rate....

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

The effectiveness of origami on overall hand function after injury: A pilot controlled trial

OpenAIRE

Wilson, L; Roden, P; Taylor, Y; Marston, L

2008-01-01

This pilot study measured the effectiveness of using origami to improve the overall hand function of outpatients attending an NHS hand injury unit. The initiative came from one of the authors who had used origami informally in the clinical setting and observed beneficial effects. These observed effects were tested experimentally. The design was a pilot non-randomised controlled trial with 13 participants. Allocation of the seven control group members was based on patient preference. The exper...

Electronic prompts significantly increase response rates to postal questionnaires: a randomized trial within a randomized trial and meta-analysis.

Science.gov (United States)

Clark, Laura; Ronaldson, Sarah; Dyson, Lisa; Hewitt, Catherine; Torgerson, David; Adamson, Joy

2015-12-01

To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). The use of electronic prompts increased response rates and reduces the time to response. Copyright © 2015 Elsevier Inc. All rights reserved.

Hemodialysis Infection Prevention Protocols Ontario—Shower Technique (HIPPO-ST: A Pilot Randomized Trial

Directory of Open Access Journals (Sweden)

S. Daisy Kosa

2017-03-01

Discussion: This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial

Directory of Open Access Journals (Sweden)

Victor Norbert

2007-09-01

perform this study as a confirmatory trial. Therefore estimates of different outcomes are performed using a pilot MRCT comparing 50 versus 50 randomized patients in order to establish a hypothesis that can be tested thereafter. If TPTX proves to have a lower rate of recurrent sHPT, no relevant disadvantages and no higher morbidity than TPTX+AT, current surgical practice may be changed. Trial registration International Standard Randomized Controlled Trial Number Registration (ISRCTN86202793

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

Science.gov (United States)

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study

Directory of Open Access Journals (Sweden)

Zhang Lang

2007-11-01

Full Text Available Abstract Background In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA. Methods The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA, traditional Chinese acupuncture (TCA and sham acupuncture (Sham in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. Results From 80 eligible patients, 36 patients with mean age of 58 ± 10 years and disease duration of 9.3 ± 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA. Trial registration ClinicalTrials.gov NCT00404443

Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

NARCIS (Netherlands)

Mohr, J.P.; Overbey, J.R.; Kummer, R. von; Stefani, M.A.; Libman, R.; Stapf, C.; Parides, M.K.; Pile-Spellman, J.; Moquete, E.; Moy, C.S.; Vicaut, E.; Moskowitz, A.J.; Harkness, K.; Cordonnier, C.; Biondi, A.; Houdart, E.; Berkefeld, J.; Klijn, C.J.M.; Barreau, X.; Kim, H.; Hartmann, A.

2017-01-01

OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults >/=18

Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

NARCIS (Netherlands)

Mohr, J P; Overbey, Jessica R; von Kummer, Ruediger; Stefani, Marco A; Libman, Richard; Stapf, Christian; Parides, Michael K; Pile-Spellman, John; Moquete, Ellen; Moy, Claudia S; Vicaut, Eric; Moskowitz, Alan J; Harkness, Kirsty; Cordonnier, Charlotte; Biondi, Alessandra; Houdart, Emmanuel; Berkefeld, Joachim; Klijn, Karin J M; Barreau, Xavier; Kim, Helen; Hartmann, Andreas; van Dijk, J. Marc C.; Luijckx, Gert Jan

2017-01-01

OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18

Effects of cholecalciferol supplementation and optimized calcium intakes on vitamin D status, muscle strength and bone health: a one-year pilot randomized controlled trial in adults with severe burns.

Science.gov (United States)

Rousseau, Anne-Françoise; Foidart-Desalle, Marguerite; Ledoux, Didier; Remy, Christophe; Croisier, Jean-Louis; Damas, Pierre; Cavalier, Etienne

2015-03-01

Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia. Vitamin D pleiotropic effects may influence bone and muscle health. The aim of this pilot study was to assess effects of a cholecalciferol (VD3) supplementation and an optimized calcium (Ca) regimen on vitamin D (VD) status, bone and muscle health during sequelar stage of burn injury. Monocentric randomized controlled trial. Fifteen adults with thermal burns dating from 2 to 5 years were randomized into two groups. For 12 months, they either received a quarterly IM injection of 200,000IU VD3 and daily oral Ca (Group D) or placebo (Group P). VD status and bone remodeling markers were assessed every 3 months. Knee muscle strength and bone mineral density were, respectively, assessed using isokinetic dynamometry and dual X-ray absorptiometry at initiation (M0) and completion (M12) of the protocol. Of all the patients, 66% presented with VD deficiency and 53% (with 3 men burn adults. When combined with optimized Ca intakes, it demonstrated positive effects on muscle health but not on bone health. A high prevalence of hypovitaminosis D and osteopenia in these patients, as well as their wide range of muscle performances, seem to be worrying when considering rehabilitation and quality of life. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial.

Directory of Open Access Journals (Sweden)

Jacqueline Kerr

Full Text Available Prolonged sitting is associated with cardiometabolic and vascular disease. Despite emerging evidence regarding the acute health benefits of interrupting prolonged sitting time, the effectiveness of different modalities in older adults (who sit the most is unclear.In preparation for a future randomized controlled trial, we enrolled 10 sedentary, overweight or obese, postmenopausal women (mean age 66 years ±9; mean body mass index 30.6 kg/m2 ±4.2 in a 4-condition, 4-period crossover feasibility pilot study in San Diego to test 3 different sitting interruption modalities designed to improve glucoregulatory and vascular outcomes compared to a prolonged sitting control condition. The interruption modalities included: a 2 minutes standing every 20 minutes; b 2 minutes walking every hour; and c 10 minutes standing every hour. During each 5-hr condition, participants consumed two identical, standardized meals. Blood samples, blood pressure, and heart rate were collected every 30 minutes. Endothelial function of the superficial femoral artery was measured at baseline and end of each 5-hr condition using flow-mediated dilation (FMD. Participants completed each condition on separate days, in randomized order. This feasibility pilot study was not powered to detect statistically significant differences in the various outcomes, however, analytic methods (mixed models were used to test statistical significance within the small sample size.Nine participants completed all 4 study visits, one participant completed 3 study visits and then was lost to follow up. Net incremental area under the curve (iAUC values for postprandial plasma glucose and insulin during the 5-hr sitting interruption conditions were not significantly different compared to the control condition. Exploratory analyses revealed that the 2-minute standing every 20 minutes and the 2-minute walking every hour conditions were associated with a significantly lower glycemic response to the second

The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C?

Directory of Open Access Journals (Sweden)

Kramer Barnett S

2002-11-01

Full Text Available Abstract Background If intervention A bests B in one randomized trial, and B bests C in another randomized trial, can one conclude that A is better than C? The problem was motivated by the planning of a randomized trial, where A is spiral-CT screening, B is x-ray screening, and C is no screening. On its surface, this would appear to be a straightforward application of the transitive principle of logic. Methods We extended the graphical approach for omitted binary variables that was originally developed to illustrate Simpson's paradox, applying it to hypothetical, but plausible scenarios involving lung cancer screening, treatment for gastric cancer, and antibiotic therapy for clinical pneumonia. Results Graphical illustrations of the three examples show different ways the transitive fallacy for randomized trials can arise due to changes in an unobserved or unadjusted binary variable. In the most dramatic scenario, B bests C in the first trial, A bests B in the second trial, but C bests A at the time of the second trial. Conclusion Even with large sample sizes, combining results from a previous randomized trial of B versus C with results from a new randomized trial of A versus B will not guarantee correct inference about A versus C. A three-arm trial of A, B, and C would protect against this problem and should be considered when the sequential trials are performed in the context of changing secular trends in important omitted variables such as therapy in cancer screening trials.

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

Science.gov (United States)

Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

2014-01-01

Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

Generalizing Evidence From Randomized Clinical Trials to Target Populations

Science.gov (United States)

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Wilson Graeme B

2012-09-01

Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

DEFF Research Database (Denmark)

Kreiner, Frederik; Galbo, Henrik

2010-01-01

To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Blinding in randomized clinical trials: imposed impartiality

DEFF Research Database (Denmark)

Hróbjartsson, A; Boutron, I

2011-01-01

Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

Science.gov (United States)

Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

2015-04-01

To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

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

Directory of Open Access Journals (Sweden)

Langford DP

2015-09-01

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

Test-based exclusion diets in gastro-esophageal reflux disease patients: a randomized controlled pilot trial.

Science.gov (United States)

Caselli, Michele; Zuliani, Giovanni; Cassol, Francesca; Fusetti, Nadia; Zeni, Elena; Lo Cascio, Natalina; Soavi, Cecilia; Gullini, Sergio

2014-12-07

To investigate the clinical response of gastro-esophageal reflux disease (GERD) symptoms to exclusion diets based on food intolerance tests. A double blind, randomized, controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors (PPI) treatment. Fasting blood samples from each patients were obtained; leukocytotoxic test was performed by incubating the blood with a panel of 60 food items to be tested. The reaction of leukocytes (rounding, vacuolization, lack of movement, flattening, fragmentation or disintegration of cell wall) was then evaluated by optical microscopy and rated as follows: level 0 = negative, level 1 = slightly positive, level 2 = moderately positive, and level 3 = highly positive. A "true" diet excluding food items inducing moderate-severe reactions, and a "control" diet including them was developed for each patient. Then, twenty patients received the "true" diet and 18 the "control" diet; after one month (T1) symptoms severity was scored by the GERD impact scale (GIS). Hence, patients in the "control" group were switched to the "true" diet, and symptom severity was re-assessed after three months (T2). At baseline (T0) the mean GIS global score was 6.68 (range: 5-12) with no difference between "true" and control group (6.6 ± 1.19 vs 6.7 ± 1.7). All patients reacted moderately/severely to at least 1 food (range: 5-19), with a significantly greater number of food substances inducing reaction in controls compared with the "true" diet group (11.6 vs 7.0, P < 0.001). Food items more frequently involved were milk, lettuce, brewer's yeast, pork, coffee, rice, sole asparagus, and tuna, followed by eggs, tomato, grain, shrimps, and chemical yeast. At T1 both groups displayed a reduction of GIS score ("true" group 3.3 ± 1.7, -50%, P = 0.001; control group 4.9 ± 2.8, -26.9%, P = 0.02), although the GIS score was significantly lower in "true" vs "control" group (P = 0.04). At T2, after the diet

Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study.

Directory of Open Access Journals (Sweden)

Jose A Muñoz-Moreno

Full Text Available To assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment.We recruited HIV-infected patients with cognitive impairment on stable antiretroviral therapy in a randomized controlled pilot trial with a 48-week follow-up. An additional assessment was held at 12 weeks. Participants received transdermal rivastigmine (9.5 mg daily, lithium (400 mg twice daily, titrated progressively, or remained in a control group (no new medication. The primary efficacy endpoint was change in a global cognitive score (NPZ-7. Secondary endpoints included change in specific cognitive measures, domains, and functional parameters. Safety covered the frequency of adverse events and changes in laboratory results.Seventy-six subjects were screened, and 29 were finally enrolled. Better cognitive outcomes were observed in all groups, although there were no significant differences between the arms (mean NPZ-7 change [SD]: rivastigmine, 0.35 (0.14; lithium, 0.25 (0.40; control, 0.20 (0.44 (p = 0.78. The rivastigmine group showed the highest positive trend (mean NPZ-7 [SD], baseline vs week 48: rivastigmine, -0.47 (0.22 vs -0.11 (0.29, p = 0.06; lithium, -0.50 (0.40 vs -0.26 (0.21, p = 0.22; control, -0.52 (0.34 vs -0.32 (0.52, p = 0.44. The cognitive domains with the highest positive trends were information processing speed at week 12 and executive function at week 48 (rivastigmine vs control: information processing speed, 0.35 (0.64 vs -0.13 (0.25, p = 0.17, d = 0.96; and executive functioning, 0.73 (0.33 vs 0.03 (0.74, p = 0.09, d = 1.18. No relevant changes were observed regarding functional outcomes. A total of 12 (41% individuals dropped out of the study: 2 (20% were due to medication-related effects in the rivastigmine group and 4 (36% in the lithium group. No severe adverse events were reported.The results from this small randomized trial indicate that transdermal rivastigmine did not provide significant

Reflexology in the management of chemotherapy induced peripheral neuropathy: A pilot randomized controlled trial.

Science.gov (United States)

Kurt, Seda; Can, Gulbeyaz

2018-02-01

The current experimental study aimed to evaluate the effectiveness of reflexology on the management of symptoms and functions of chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. This study was conducted as a randomized controlled trial in 60 patients (30 experimental and 30 control patients) who had chemotherapy-induced Grade II-IV peripheral neuropathy complaints from July 2013 to November 2015. Data were collected using the patient identification form, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN-20) form, and BPI (used for related chemotherapy-induced peripheral neuropathy symptoms). The majority of the patients were being treated for gastrointestinal or breast cancer and were primarily receiving Eloxatine- or taxane-based treatment. It was found that reflexology applications did not lead to differences in either group in terms of peripheral neuropathy severity and incidence (p > 0.05) and only led to improvement in sensory functions in the experimental group (p Peripheral neuropathy, reflexology, chemotherapy, EORTC QLQ-CIPN-20, BPI. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

Directory of Open Access Journals (Sweden)

Alfredo D. Oliveira-Filho

2014-12-01

Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders.