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Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

ABSTRACT: OBJECTIVES:To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity. DESIGN:A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations. SETTING:Community settings across two sites in Devon. PARTICIPANTS:Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation. INTERVENTIONS:ReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet. OUTCOME MEASURES:Candidate primary outcomes included functional mobility and physical activity. RESULTS:Forty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations. CONCLUSIONS:All objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable. TRIAL REGISTRATION NUMBER:NCT02429180; Results.

SUBMITTER: Dean SG

PROVIDER: S-EPMC5829775 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

Dean Sarah G SG Poltawski Leon L Forster Anne A Taylor Rod S RS Spencer Anne A James Martin M Allison Rhoda R Stevens Shirley S Norris Meriel M Shepherd Anthony I AI Landa Paolo P Pulsford Richard M RM Hollands Laura L Calitri Raff R

BMJ open 20180215 2

<h4>Objectives</h4>To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.<h4>Design</h4>A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.<h4>Setting</h4>Community settings across two sites in Devon.<h4>Participants</h4>Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported m ...[more]

PMID: 29449290

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Project description:INTRODUCTION:The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS:A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9?months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION:National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER:NCT02429180; Pre-results.

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:ObjectivesThe Solution Focused Brief Therapy in Post-Stroke Aphasia feasibility trial had four primary aims: to assess (1) acceptability of the intervention to people with aphasia, including severe aphasia, (2) feasibility of recruitment and retention, (3) acceptability of research procedures and outcome measures, and (4) feasibility of delivering the intervention by speech and language therapists.DesignTwo-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research.SettingParticipants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups).ParticipantsPeople with aphasia at least 6 months post stroke.InterventionSolution-focused brief therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over 3 months, either immediately postrandomisation or after a delay of 6 months.Outcome measuresPrimary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, 3 and 6 months postrandomisation, and at 9 months (wait-list group only). The candidate primary outcome measure was the Warwick-Edinburgh Mental Well-being Scale. Participants and therapists also took part in in-depth interviews.ResultsThirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable by both participants (n=30 interviews) and therapists (n=3 interviews); 93.8% of participants had ≥2 therapy sessions (90.6% had 6/6 sessions). Feasibility endpoints: recruitment target was reached within the prespecified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at 6 months; missing data <0.01%. All five prespecified feasibility progression criteria were met.ConclusionThe high retention and adherence rates, alongside the qualitative data, suggest the study design was feasible and therapy approach acceptable even to people with severe aphasia. These results indicate a definitive randomised controlled trial of the intervention would be feasible.Trial registration numberNCT03245060.

Project description:ObjectiveTo assess the feasibility and acceptability of training community health workers (CHWs) in ear and hearing care, and their ability to identify patients with ear and hearing disorders.DesignCluster randomised controlled trial (RCT).SettingHealth centres in Thyolo district, Malawi.ParticipantsTen health centres participated, 5 intervention (29 CHWs) and 5 control (28 CHWs).InterventionIntervention CHWs received 3 days of training in primary ear and hearing care, while among control CHWs, training was delayed for 6 months. Both groups were given a pretest that assessed knowledge about ear and hearing care, only the intervention group was given the posttest on the third day of training. The intervention group was given 1?month to identify patients with ear and hearing disorders in their communities, and these people were screened for hearing disorders by ear, nose and throat clinical specialists.Outcome measuresPrimary outcome measure was improvement in knowledge of ear and hearing care among CHWs after the training. Secondary outcome measures were number of patients with ear or hearing disorders identified by CHWs and number recorded at health centres during routine activities, and the perceived feasibility and acceptability of the intervention.ResultsThe average overall correct answers increased from 55% to 68% (95% CI 65 to 71) in the intervention group (p<0.001). A total of 1739 patients with potential ear and hearing disorders were identified by CHWs and 860 patients attended the screening camps, of whom 400 had hearing loss (73 patients determined through bilateral fail on otoacoustic emissions, 327 patients through audiometry). Where cause could be determined, the most common cause of ear and hearing disorders was chronic suppurative otitis media followed by impacted wax. The intervention was perceived as feasible and acceptable to implement.ConclusionsTraining was effective in improving the knowledge of CHW in ear and hearing care in Malawi and allowing them to identify patients with ear and hearing disorders. This intervention could be scaled up to other CHWs in low-income and middle-income countries.Trial registration numberPan African Clinical Trial Registry (201705002285194); Results.

Project description:BACKGROUND:The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used. METHODS:Clinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used. RESULTS:Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support. CONCLUSION:Recruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

Project description:Motor imagery (MI) when combined with physiotherapy can offer functional benefits after stroke. Two MI integration strategies exist: added and embedded MI. Both approaches were compared when learning a complex motor task (MT): 'Going down, laying on the floor, and getting up again'.Outpatients after first stroke participated in a single-blinded, randomised controlled trial with MI embedded into physiotherapy (EG1), MI added to physiotherapy (EG2), and a control group (CG). All groups participated in six physiotherapy sessions. Primary study outcome was time (sec) to perform the motor task at pre and post-intervention.level of help needed, stages of MT-completion, independence, balance, fear of falling (FOF), MI ability. Data were collected four times: twice during one week baseline phase (BL, T0), following the two week intervention (T1), after a two week follow-up (FU). Analysis of variance was performed.Thirty nine outpatients were included (12 females, age: 63.4 ± 10 years; time since stroke: 3.5 ± 2 years; 29 with an ischemic event). All were able to complete the motor task using the standardised 7-step procedure and reduced FOF at T0, T1, and FU. Times to perform the MT at baseline were 44.2 ± 22s, 64.6 ± 50s, and 118.3 ± 93s for EG1 (N = 13), EG2 (N = 12), and CG (N = 14). All groups showed significant improvement in time to complete the MT (p < 0.001) and degree of help needed to perform the task: minimal assistance to supervision (CG) and independent performance (EG1+2). No between group differences were found. Only EG1 demonstrated changes in MI ability over time with the visual indicator increasing from T0 to T1 and decreasing from T1 to FU. The kinaesthetic indicator increased from T1 to FU. Patients indicated to value the MI training and continued using MI for other difficult-to-perform tasks.Embedded or added MI training combined with physiotherapy seem to be feasible and benefi-cial to learn the MT with emphasis on getting up independently. Based on their baseline level CG had the highest potential to improve outcomes. A patient study with 35 patients per group could give a conclusive answer of a superior MI integration strategy.ClinicalTrials.gov: NCT00858910.

Project description:The lack of knowledge of advance care planning and training of communication skills among nurses in Taiwan is one of the main reasons for the low rate of advance directive signing. However, there is no specific and effective solution to this problem. The purposes of this study were (1) to develop and pilot testing of an advance care planning simulation-based communication training program and (2) to evaluate the feasibility and acceptability of the program. This study was conducted in three phases. Phase 1: Developing an advance care planning simulation-based communication training program; Phase 2: Conducting a pilot test; Phase 3: Evaluating the feasibility and acceptability of the program. Twelve convenient participants from a medical center in central Taiwan were selected. The participants believed that team-based learning was beneficial for several reasons. First, it helped to clarify the participants' understanding of advance care planning and improve their communication skills. Second, role-playing, as one of the components, was helpful for discovering their own shortcomings in communication skills while debriefing enabled them to identify their blind spots in the communication process. Finally, the reflection log documented their weekly performance so they were able to reflect upon their weekly performance, improve their performance, and become more confident. All twelve participants signed the consent form and completed the whole training program. The participants were satisfied with the program, affirming that the timing and content of the program were appropriate and that the expected learning outcomes could be achieved. According to participant feedback, the program was beneficial in improving their knowledge of advance care planning and confidence in communication. Thus, it is feasible and acceptable to introduce communication of advance care planning programs into the staff training protocols of healthcare organizations. Clinical trial registration: NCT04312295.

Project description:Telehealth education has the potential to serve as an important, low-cost method of expanding healthcare worker education and support, especially in rural settings of low- and middle-income countries. We describe an innovative educational strategy to strengthen a long-term health professional capacity building partnership between Guatemalan and US-based partners. In this pilot evaluation, community health nurses in rural Guatemala received customized, interactive education via telehealth from faculty at the supporting US-based institution. Program evaluation of this 10 lecture series demonstrated high levels of satisfaction among learners and instructors as well as knowledge gain by learners. An average of 5.5 learners and 2 instructors attended the 10 lectures and completed surveys using a Likert scale to rate statements regarding lecture content, technology, and personal connection. Positive statements about lecture content and the applicability to daily work had 98% or greater agreement as did statements regarding ease of technology and convenience. The learners agreed with feeling connected to the instructors 100% of the time, while instructors had 86.4% agreement with connection related statements. Instructors, joining at their respective work locations, rated convenience statements at 100% agreement. This evaluation also demonstrated effectiveness with an average 10.7% increase in pre- to posttest knowledge scores by learners. As the global health community considers efficiency in time, money, and our environment, telehealth education is a critical method to consider and develop for health worker education. Our pilot program evaluation shows that telehealth may be an effective method of delivering education to frontline health workers in rural Guatemala. While larger studies are needed to quantify the duration and benefits of specific knowledge gains and to perform a cost-effectiveness analysis of the program, our initial pilot results are encouraging and show that a telehealth program between a US-based university and a rural community health program in a low- and middle-income country is both feasible and acceptable.

Dataset Information

Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

Publications

Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

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