Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults.
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ABSTRACT:
SUBMITTER: Best KL
PROVIDER: S-EPMC5512940 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
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Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults.
Best Krista L KL Miller William C WC Routhier François F Eng Janice J JJ
Pilot and feasibility studies 20170717
<h4>Background</h4>A novel peer-led manual wheelchair (MWC) training program may support the training needs of older adults, but establishing program feasibility is a pragmatic first step. The purpose of this study was to evaluate the feasibility of a peer-led Wheelchair training Self-Efficacy Enhanced for Use (WheelSeeU) program.<h4>Methods</h4>Forty MWC users (mean age 65 years) were randomly assigned to the experimental (WheelSeeU) or control group. Feasibility indicators of process, resource ...[more]
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Project description:ObjectiveTo improve the quality of peer leader training, this study developed a theory-based self-management training program for older adult peer leaders with diabetes and assessed its feasibility.BackgroundCurrent self-management programs are designed mainly to be implemented by healthcare professionals, but healthcare staff may not fully perceive the needs and obstacles of older adults in disease management due to a lack of similar illness experience. To target this problem, peer leaders with successful self-management experiences, similar cultural backgrounds and languages, and related illness experiences are trained to guide and mentor peer patients in self-management programs.Study design and methodsThis study was conducted in two stages. In stage 1, a peer leader training program was developed based on experiential learning theory as the framework and self-regulation theory as the activity design strategy. In stage 2, program feasibility was assessed via participants' feedback toward the training program by three indicators: attendance, future willingness to lead the peer-led self-management program, and leadership skills evaluated by a peer leader training assessment tool.ResultsIn this study, peer leaders demonstrated good leadership skills by expressing active willingness to lead self-management programs in the community. Peer leaders' feedback indicated that the program's training content was helpful in preparing peer leaders to guide older adults in learning self-management skills and in improving the abilities and confidence of peer leaders in mentoring self-management.ConclusionFindings in this study showed that peer leader training can impact the effectiveness and success of self-management in older adults with diabetes. Even in a small-scale study, the impact was evident, which demonstrated the feasibility of the program. More large-scale studies on the effectiveness of various peer leader training programs in diverse disciplines are recommended.Clinical trials registryClinicalTrials.gov Identifier: NCT04298424 (the Peer-Led Self-Management Program).
| S-EPMC7800687 | biostudies-literature
Project description:BACKGROUND:Providing mobility skills training to manual wheelchair (MWC) users can have a positive impact on community participation, confidence and quality of life. Often such training is restricted or not provided at all because of the expense of, and limited access to, occupational and physical therapists before and after discharge. This is particularly true among middle-aged and older adults, who often have limited access to rehabilitation services and require more time to learn motor skills. A monitored MWC skills training home program, delivered using a computer tablet (mHealth), was developed as an alternative approach to service delivery. The purpose of this study was to evaluate the feasibility of implementing this mHealth MWC skills training program among middle-aged and older adults. METHODS:A 2 × 2 factorial design randomized controlled trial (RCT) was used to compare the mHealth intervention and control groups, with additional wheeling time as a second factor. Community-dwelling MWC users aged 55 and older, who had used their MWC for less than two years and propelled with two hands, were recruited. Feasibility outcomes related to process, resources, management and treatment criteria were collected. RESULTS:Eighteen participants were recruited, with a retention rate of 94%. Mean (±SD) duration for the first and second in-person training sessions were 90.1 ± 20.5 and 62.1 ± 5.5 min, respectively. In the treatment group, 78% achieved the minimum amount of home training (i.e., 300 min) over four weeks and 56% achieved the preferred training threshold (i.e., 600 min). Trainers reported only seven minor protocol deviations. No tablets were lost or damaged and there was one incident of tablet malfunction. No injuries or adverse incidents were reported during data collection or training activities. Participants indicated 98% agreement on the post-treatment benefit questionnaire. DISCUSSION:Overall, the study protocol enabled implementation of the intervention in a safe, efficient and acceptable manner. Participant recruitment proved to be challenging, particularly gaining access to individuals who might benefit. Resource issue demands were acceptable for administration of the intervention; data collection was more time-consuming than anticipated but could be reduced with minor revisions. Participant retention and home program treatment adherence was high; both participant and trainer burden was acceptable. Treatment group participants reported a positive experience and clinical benefits from training program. The findings suggest a full-scale RCT evaluating the clinical impact of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) intervention is warranted, provided the recruitment issues are addressed through collaborative partnerships and active recruitment strategies.
| S-EPMC5632536 | biostudies-literature
Project description:Rationale and Objective The ‘PEER-HD’ multicenter study tests the effectiveness of peer mentorship to reduce hospitalizations in patients receiving maintenance hemodialysis. In this study, we describe the feasibility, efficacy, and acceptability of the mentor training program. Study Design Educational program evaluation including the following aspects: (1) description of training content, (2) quantitative analysis of feasibility and acceptability of the program, and (3) quantitative pre-post analysis of efficacy of the training to impart knowledge and self-efficacy. Setting and Participants Data were collected using baseline clinical and sociodemographic questionnaires from mentor participants enrolled in Bronx, NY, and Nashville, TN, themselves receiving maintenance hemodialysis. Analytical Approach The outcome variables were the following: (1) feasibility measured by training module attendance and completion, (2) efficacy of the program to impart knowledge and self-efficacy measured by kidney knowledge and self-efficacy surveys, and (3) acceptability as measured by an 11-item survey of trainer performance and module content. Results The PEER-HD training program included 4 2-hour modules that covered topics including dialysis-specific knowledge and mentorship skills. Of the 16 mentor participants, 14 completed the training program. There was complete attendance to all training modules, though some patients required flexibility in scheduling and format. Performance on posttraining quizzes was consistent with high knowledge (mean scores ranged from 82.0%-90.0% correct). Mean dialysis-specific knowledge scores trended higher post training than at baseline though this difference was not statistically significant (90.0% vs 78.1%; P = 0.1). No change in mean self-efficacy scores was demonstrated from before to after training, among mentor participants (P = 0.2). Program evaluation assessments of acceptability were favorable [mean of all patient scores (0-4) within each module ranged from 3.43-3.93]. Limitations Small sample size. Conclusions The PEER-HD mentor training program required accommodation to patients’ schedules but was feasible. Participants rated the program favorably, and although the comparison of performance on knowledge assessments post- and pre-program showed uptake of knowledge, this was not statistically significant. Graphical abstract
| S-EPMC10149397 | biostudies-literature
Project description:BackgroundTreatment for hoarding disorder is typically performed by mental health professionals, potentially limiting access to care in underserved areas.AimsWe aimed to conduct a non-inferiority trial of group peer-facilitated therapy (G-PFT) and group psychologist-led cognitive-behavioural therapy (G-CBT).MethodWe randomised 323 adults with hording disorder 15 weeks of G-PFT or 16 weeks of G-CBT and assessed at baseline, post-treatment and longitudinally (≥3 months post-treatment: mean 14.4 months, range 3-25). Predictors of treatment response were examined.ResultsG-PFT (effect size 1.20) was as effective as G-CBT (effect size 1.21; between-group difference 1.82 points, t = -1.71, d.f. = 245, P = 0.04). More homework completion and ongoing help from family and friends resulted in lower severity scores at longitudinal follow-up (t = 2.79, d.f. = 175, P = 0.006; t = 2.89, d.f. = 175, P = 0.004).ConclusionsPeer-led groups were as effective as psychologist-led groups, providing a novel treatment avenue for individuals without access to mental health professionals.Declaration of interestC.A.M. has received grant funding from the National Institutes of Health (NIH) and travel reimbursement and speakers' honoraria from the Tourette Association of America (TAA), as well as honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. K.D. receives research support from the NIH and honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. R.S.M. receives research support from the National Institute of Mental Health, National Institute of Aging, the Hillblom Foundation, Janssen Pharmaceuticals (research grant) and the Alzheimer's Association. R.S.M. has also received travel support from the National Institute of Mental Health for Workshop participation. J.Y.T. receives research support from the NIH, Patient-Centered Outcomes Research Institute and the California Tobacco Related Research Program, and honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. All other authors report no conflicts of interest.
| S-EPMC6066983 | biostudies-literature
Project description:BackgroundMany older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial.MethodsA 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life.DiscussionThe EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses.Trial registrationClinical Trials NCT01740635.
| S-EPMC3874600 | biostudies-literature
Project description:BackgroundA peer-led exercise program is one way to empower people sharing similar characteristics to encourage others to be active, but there is a lack of evidence that these programs have physical function and other benefits when delivered to ageing adults.MethodsThis randomized controlled trial lasting 12 weeks proposed an exercise peer-led program offered to 31 adults aged 50 and above, twice a week, by a trained leader of the same age from March to May 2019. The program was offered for free with limited space and equipment. Valid tests of physical function (e.g., 30-s chair stand, 6-min walk test) were used to assess the functional benefits. Psychosocial outcomes were assessed using self-reported questionnaires and metabolic outcomes via a fasted blood draw.ResultsA significant difference was found between pre-and post-values in most physical function tests in the intervention group (all p < 0.05). When adjusted for potential confounders, the intervention group was significantly associated with a more significant improvement on the chair stand test (ß = .26; p < 0.001; r2 = 0.26), the arm curl (ß = .29; p < 0.001; r2 = 0.49), as well as the 6-min walk test (ß = -.14; p < 0.001; r2 = 0.62) compared with the control group. Using repetitive measures generalized linear model, the interaction between the changes and the group was significant for all three tests. Benefits were also observed for participants' stress level and perceived health in the intervention group compared to the control. Finally, no significant difference was observed between groups for metabolic health.ConclusionsThe current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above.Trial registrationNCT03799952 (ClinicalTrials.gov) 12/20/2018.
| S-EPMC7879524 | biostudies-literature
Project description:ObjectivesTo test the hypotheses that, in comparison with a control group that received standard care, users of manual wheelchairs who also received the French-Canadian version of the Wheelchair Skills Training Program (WSTP) would significantly improve their wheelchair-skills capacity and that these improvements would be retained at 3 months.DesignMulticenter, single-blind, randomized controlled trial.SettingThree rehabilitation centers in Montréal, Quebec, Canada.ParticipantsManual wheelchair users (N=39), a sample of convenience.InterventionParticipants were randomly allocated to the WSTP or control groups. Participants in both groups received standard care. Participants in the WSTP group also received a mean of 5.9 training sessions (a mean total duration of 5h and 36min).Main outcome measuresThe French-Canadian version of the Wheelchair Skills Test (WST) (Version 3.2) was administered at evaluation at first time period (baseline) (t1), evaluation at second time period (posttraining) (t2) (a mean of 47d after t1), and at evaluation at third time period (follow-up) (t3) (a mean of 101d after t2).ResultsAt t2, the mean ± SD total percentage WST capacity scores were 77.4%±13.8% for the WSTP group and 69.8%±18.4% for the control group (P=.030). Most of this difference was due to the community-level skills (P=.002). The total and subtotal Wheelchair Skills Test scores at t3 decreased by ≤0.5% from the t2 values, but differences between groups at t3, adjusting for t1, did not reach statistical significance (P≥.017 at a Bonferroni-adjusted α level of .005).ConclusionWSTP training improves wheelchair skills immediately after training, particularly at the community-skills level, but this study did not show statistically significant differences between the groups at 3 months.
| S-EPMC3708861 | biostudies-literature
Project description:BackgroundExergame-based motor-cognitive training in older adults has been associated with improvements in physical, cognitive, and psychological functioning. The novel Cocare system (Dividat GmbH), developed through a user-centered design process, allows motor-cognitive training in a telerehabilitation setting. It includes (1) a stationary stepping platform for supervised exergame training (Dividat Senso; Dividat GmbH), (2) a home-based version (Dividat Senso Flex, which is a rollable pressure-sensitive mat; Dividat GmbH), (3) an assessment system (including motor-cognitive tests), and (4) a rehabilitation cockpit for remote training supervision and management.ObjectiveThe aim of this study is to test the feasibility and effectiveness of this novel training system.MethodsA total of 180 older adults from Switzerland, Italy, and Cyprus aged ≥60 years with a prescription for rehabilitation are randomly allocated to an intervention group or a control group. Both groups continue with their usual care, whereas participants in the intervention group additionally perform a 2-week supervised exergame training program at rehabilitation centers, followed by a 10-week home training program under remote supervision. The assessment system is used to indicate the start level of each participant, and, in both intervention periods, standardized progression rules are applied. The measures of feasibility include adherence, attrition, exergame enjoyment, willingness to perform such a training program, and the number and types of help requests. Effectiveness is assessed in terms of cognitive and physical functioning, balance confidence, and quality of life.ResultsData collection started in February 2023 and is ongoing. Final measurements are expected to be performed in January 2024.ConclusionsOwing to the user-centered design approach, the Cocare system is expected to be user-friendly and offers several novel features to cover the whole continuum of care. This pragmatic trial will provide valuable information regarding final necessary adaptations and subsequent implementation efforts.Trial registrationClinicalTrials.gov NCT05751551; https://www.clinicaltrials.gov/study/NCT05751551.International registered report identifier (irrid)DERR1-10.2196/49377.
| S-EPMC10667977 | biostudies-literature
Project description:BackgroundThe risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese.MethodsThe Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial.DiscussionThis paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI.Trial registrationwww.clinicaltrials.gov; NCT02175641, registered 24 June 2014.
| S-EPMC4557630 | biostudies-literature
Project description:BackgroundAdvanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve.MethodsA single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS) Instructor.A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups) if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents.The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks.Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE). The checklist items were based on International Liaison Committee on Resuscitation (ILCOR) guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness.The results were analysed using Exact methods, chi-squared and t-test.ResultsA total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98%) of students from the expert-led group achieved a Pass compared to 72/74 (97%) from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001) that the expert-led group was 20% better than the peer-led group.There were no safety incidents, and High Pass grades were achieved by 64 (49%) of students: 33/58 (57%) from the expert-led group, 31/74 (42%) from the peer-led group. Exact statistics showed that the difference of 15% meant that it was possible that the expert-led teaching was 20% better at generating students with High Passes.ConclusionsThe key elements of advanced cardiac resuscitation can be safely and effectively taught to medical students in small groups by peer-instructors who have undergone basic medical education training.
| S-EPMC2818633 | biostudies-literature