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Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial.

ABSTRACT: INTRODUCTION:The objective of this study is to conduct a pilot randomised controlled trial (RCT) of the Ontario Brain Injury Association (OBIA) Peer Support Program. The RCT is designed to evaluate the effectiveness and dose-response of the Peer Support Program in improving participation and mood for people with moderate-to-severe traumatic brain injury compared with a wait-list control group. METHODS AND ANALYSIS:The proposed research is a three-phase, mixed methods pilot RCT. Consistent with an integrated knowledge translation approach, the study design has been informed in consultation with the knowledge user (ie, OBIA). It will include an initial qualitative examination of barriers and enablers to the trial implementation (phase 1), a pilot RCT (phase 2) and conclude with a qualitative component (phase 3). A qualitative descriptive approach will be adopted for both qualitative phases of the study (n=20-25) and thematic analysis will be used. The 6 months phase-2 trial will be conducted with 60 participants. These participants will be randomised to one of three groups: a twice a week programme (n=20), a once a week programme (n=20) or the wait-list control group (n=20). The feasibility of participant recruitment and retention, data collection, as well as participant adherence to the OBIA Peer Support Program will be evaluated. The primary outcome measure will be participation, as measured by the Participation Assessment with Recombined Tools-Objective. Other proposed outcomes of interest will include mood, health-related quality of life and self-efficacy. ETHICS AND DISSEMINATION:Ethics approval will be obtained from the principal author's institution (University Health Network Research Ethics Board). The results of this study will inform the development of a larger scale RCT and will inform future iterations of the OBIA Peer Support Program including a revised programme curriculum. TRIAL REGISTRATION NUMBER:NCT03450460; Pre-results.

SUBMITTER: Munce SEP

PROVIDER: S-EPMC6475259 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial.

Munce Sarah E P SEP Jaglal Susan S Kastner Monika M Nelson Michelle L A MLA Salbach Nancy M NM Shepherd John J Sweet Shane N SN Wilcock Ruth R Thoms Carla C Bayley Mark T MT

BMJ open 20190323 3

<h4>Introduction</h4>The objective of this study is to conduct a pilot randomised controlled trial (RCT) of the Ontario Brain Injury Association (OBIA) Peer Support Program. The RCT is designed to evaluate the effectiveness and dose-response of the Peer Support Program in improving participation and mood for people with moderate-to-severe traumatic brain injury compared with a wait-list control group.<h4>Methods and analysis</h4>The proposed research is a three-phase, mixed methods pilot RCT. Co ...[more]

PMID: 30904839

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Project description:INTRODUCTION:Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person's needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study. METHODS AND ANALYSIS:A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme. ETHICS AND DISSEMINATION:Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.

Project description:INTRODUCTION:This study will evaluate the effectiveness of an innovative peer support programme. The programme incorporates leadership training, mentorship, recognition and reward systems for peer support workers, and supportive/reminder text messaging for patients discharged from acute (hospital) care. We hypothesise that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. METHODS AND ANALYSIS:This is a prospective, rater-blinded, four-arm randomised controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomised to one of four conditions: (1) enrolment in a peer support system; (2) enrolment in a peer support system plus automated daily supportive/reminder text messages; (3) enrolment in automated daily supportive/reminder text messages alone; or (4) treatment as usual follow-up care. Patients in each group will complete evaluation measures (eg, recovery, general symptomatology and functional outcomes) at baseline, 6?months and 12months. Patient service utilisation data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analysed with descriptive statistics, repeated measures and correlational analyses. The peer support worker experience will be captured using qualitative methods. ETHICS AND DISSEMINATION:The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). The study has received ethical clearance from the Health Ethics Research Board of the University of Alberta (Ref # Pro00078427) and operational approval from our regional health authority (AHS- (PRJ) #35293). All participants will provide informed consent prior to study inclusion. The results will be disseminated at several levels, including patients/peer supports, practitioners, academics/researchers, and healthcare organisations. TRIAL REGISTRATION NUMBER:NCT03404882; Pre-results.

Project description:IntroductionPersistent somatic symptoms (PSS) are common both in the general population and primary care. They are bothersome in terms of psychological and somatic symptom burden. Health professionals often struggle with communication, as there is a lack of scientifically supported explanatory models for PSS or a focus merely on somatic aspects of the complaints, which both frustrate patients' needs. The objective of the present study is therefore to develop a psychoeducational intervention based on a current evidence-based explanatory model, to examine its feasibility and form the basis for a large-scale randomised controlled trial.Methods and analysisIn a randomised controlled mixed-methods pilot trial, 75 adult psychosomatic outpatients with PSS (duration of symptoms ≥6 months) and accompanying psychological (Somatic Symptom B-Criteria Scale total score ≥18) and somatic symptom burden (Patient Health Questionnaire-15 score >10) and no prior psychosomatic treatment will be eligible. Participants will be presented with either the explanatory model without (intervention group 1, n=25) or with elements of personalisation (intervention group 2, n=25). Participants in the control group (n=25) will receive information on current PSS guidelines. Participants will be blinded to group assignment and interventions will be shown on tablet computers at the outpatient clinic. After 1 month, qualitative follow-up telephone interviews will be conducted. As primary outcomes, mean changes in psychological and somatic symptom burden will quantitatively be compared between groups, respectively. Behavioural change mechanisms and feasibility of the three interventions will be evaluated using quantitative and qualitative measures.Ethics and disseminationEthics approval has been granted by the medical ethics board of the Hamburg Medical Chamber (PV5653). Results from this study will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberDRKS00018803.

Project description:Peer support is a widely used intervention that offers information and emotional support to parents during their infant's admission to the neonatal unit and/or post-discharge. Despite its widespread use, there are no comprehensive insights into the nature and types of neonatal-related peer support, or the training and support offered to peer supporters. We aimed to bridge these knowledge gaps via an international study into neonatal peer support provision. A mixed-methods study comprising an online survey was issued to peer support services/organisations, and follow-up interviews held with a purposive sample of survey respondents. Survey/interview questions explored the funding, types of peer support and the recruitment, training and support for peer supporters. Descriptive and thematic analysis was undertaken. Thirty-one managers/coordinators/trainers and 77 peer supporters completed the survey from 48 peer support organisations/services in 16 different countries; with 26 interviews undertaken with 27 survey respondents. We integrated survey and interview findings into five themes: 'background and infrastructure of peer support services', 'timing, location and nature of peer support', 'recruitment and suitability of peer supporters', 'training provision' and 'professional and emotional support'. Findings highlight variations in the types of peer support provided, training and development opportunities, supervisory and mentoring arrangements and the methods of recruitment and support for peer supporters; with these differences largely related to the size, funding, multidisciplinary involvement, and level of integration of peer support within healthcare pathways and contexts. Despite challenges, promising strategies were reported across the different services to inform macro (e.g. to facilitate management and leadership support), meso (e.g. to help embed peer support in practice) and micro (e.g. to improve training, supervision and support of peer supporters) recommendations to underpin the operationalisation and delivery of PS provision.

Project description:BACKGROUND:Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to accrue health benefits. The Active Living Lifestyles program for individuals with SCI who use manual wheelchairs (ALLWheel) targets important psychological factors that are associated with LTPA uptake and adherence while overcoming some barriers associated with participation restrictions. OBJECTIVE:The goal of the paper is to describe the protocol for the development and evaluation of the ALLWheel program for individuals with SCI who use manual wheelchairs. METHODS:The first three stages of the Medical Research Council framework for developing and evaluating complex interventions (ie, preclinical, modeling, exploratory) are described. The preclinical phase will consist of scoping and systematic reviews and review of theory. The intervention will be modeled by expert opinions and consensus through focus groups and Delphi surveys with individuals with SCI, clinicians, and community partners. Finally, the feasibility and potential influence of the ALLWheel program on LTPA and psychological outcomes will be evaluated. RESULTS:This project is funded by the Craig H Neilsen Foundation, the Fonds de Recherche du Québec-Santé, and the Canadian Disability Participation Project and is currently underway. CONCLUSIONS:Using peer trainers and mobile phone technology may help to cultivate autonomy-supportive environments that also enhance self-efficacy. Following a framework for developing and evaluating a novel intervention that includes input from stakeholders at all stages will ensure the final product (ie, a replicable intervention) is desirable to knowledge users and ready for evaluation in a randomized controlled trial. If effective, the ALLWheel program has the potential to reach a large number of individuals with SCI to promote LTPA uptake and adherence. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10798.

Project description:BackgroundiSupport is an online program developed by the World Health Organization to provide education, skills training, and social support to informal carers of persons with dementia. This pilot study examines the feasibility of the protocol for a main effectiveness trial of iSupport-Portugal and explores how the intervention and control arms compare over time on well-being outcomes.MethodsA mixed-methods experimental parallel between-group design with two arms is followed. Participants were recruited nationwide, by referral or advertising, through the National Alzheimer's Association. Inclusion criteria are being Portuguese adults, providing e-consent, providing unpaid care to someone with dementia for at least 6 months, experiencing relevant scores on burden (≥ 21 on ZBI) or depression or anxiety (≥ 8 on HADS), and using webpages autonomously. Participants were consecutively randomized to receive iSupport-Portugal or an education-only e-book and were not blinded to group assignment. Data were collected online with self-administered instruments, at baseline, 3 and 6 months after. Outcomes comprise caregiver burden, depression, anxiety, QoL, positive aspects of caregiving, and self-efficacy. Generalized estimating equations were used to estimate group, time, and group-by-time effects. Intervention engagement data were extracted from iSupport's platform. Semi-structured interviews were conducted.ResultsForty-two participants were allocated to the intervention (N = 21) and control (N = 21) arms. Participation (78.1%) and retention rates (73.8%) were fair. More carers in the control arm completed the study (N = 20, 95.2%) than in the intervention arm (N = 11; 52.4%) (χ2 = 9.98, p = .002). Non-completers were younger, spent less time caring, and scored higher on anxiety. Among carers in the intervention arm, the average attendance rate was of 53.7%. At post-test 38.9% of participants still used iSupport; the remainder participants interrupted use within 2 weeks (Mdn). For per-protocol analyses, significant group-by-time interaction effects favouring the intervention were found for anxiety (Wald χ2 = 6.17, p = .046) and for environmental QoL (Wald χ2 = 7.06, p = .029). Those effects were not observed in intention-to-treat analyses adjusted for age. Interviewees from the intervention arm (N = 12) reported positive results of iSupport on knowledge and on experiencing positive feelings. No adverse effects were reported.ConclusionsThis study provides information for a forthcoming full-scale effectiveness trial, as on the acceptability and potential results of iSupport-Portugal. iSupport is suggested as a relevant resource for Portuguese carers.Trial registrationClinicalTrials.gov, NCT04104568 . 26/09/2019.

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Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial.

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Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial.

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