Dataset Information

Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).

ABSTRACT: Background:Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design:SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n?=?30) with usual care + peer befriending (n?=?30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10?months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n?=?20) and significant others (n?=?10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5?L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). Discussion:This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. Trial registration:ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016.

SUBMITTER: Hilari K

PROVIDER: S-EPMC6341752 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).

Hilari Katerina K Behn Nicholas N Marshall Jane J Simpson Alan A Thomas Shirley S Northcott Sarah S Flood Chris C McVicker Sally S Jofre-Bonet Mireia M Moss Becky B James Kirsty K Goldsmith Kimberley K

Pilot and feasibility studies 20190122

<h4>Background</h4>Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention.<h4>Methods/design</h4>SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia pos ...[more]

PMID: 30693094

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Project description:ObjectiveTo evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia.DesignSUpporting wellbeing through Peer-befriending (SUPERB) was a feasibility randomised controlled trial comparing usual care to usual care +peer-befriending. This paper reports on the fidelity of all intervention aspects (training and supervision of providers/befrienders; intervention visits) which was evaluated across all areas of the Behaviour Change Consortium framework.SettingCommunity.ParticipantsPeople with aphasia early poststroke and low levels of distress, randomised to the intervention arm of the trial (n=28); 10 peer-befrienders at least 1-year poststroke.InterventionPeer-befrienders were trained (4-6 hours); and received regular supervision (monthly group while actively befriending, and one-to-one as and when needed) in order to provide six 1-hour peer-befriending visits over 3 months.Main measuresMetrics included number and length of training, supervision sessions and visits. All training and supervision sessions and one (of six) visits per pair were rated against fidelity checklists and evaluated for inter-rater and intrarater reliability (Gwets AC1 agreement coefficient). Per-cent adherence to protocol was evaluated.ResultsAll peer-befrienders received 4-6 hours training over 2-3 days as intended. There were 25 group supervision sessions with a median number attended of 14 (IQR=8-18). Twenty-six participants agreed (92.8%) to the intervention and 21 (80.8%) received all six visits (median visit length 60 min). Adherence was high for training (91.7%-100%) and supervision (83%-100%) and moderate-to-high for befriending visits (66.7%-100%). Where calculable, inter-rater and intrarater reliability was high for training and supervision (Gwets AC1 >0.90) and moderate-to-high for intervention visits (Gwets AC1 0.44-1.0).ConclusionPlanning of fidelity processes at the outset of the trial and monitoring throughout was feasible and ensured good-to-high fidelity for this peer-befriending intervention. The results permit confidence in other findings from the SUPERB trial.Trial registration numberNCT02947776.

Project description:ObjectiveTo determine the feasibility and acceptability of peer-befriending, for people with aphasia.DesignSingle-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending.Participants and settingPeople with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community.InterventionSix 1-hour peer-befriending visits over three months.Main measuresFeasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending.ResultsOf 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated.ConclusionsSUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

Project description:To examine the feasibility and potential benefits of early peer support to improve the health and quality of life of individuals with early inflammatory arthritis (EIA).Feasibility study using the 2008 Medical Research Council framework as a theoretical basis. A literature review, environmental scan, and interviews with patients, families and healthcare providers guided the development of peer mentor training sessions and a peer-to-peer mentoring programme. Peer mentors were trained and paired with a mentee to receive (face-to-face or telephone) support over 12 weeks.Two academic teaching hospitals in Toronto, Ontario, Canada.Nine pairs consisting of one peer mentor and one mentee were matched based on factors such as age and work status.Mentee outcomes of disease modifying antirheumatic drugs (DMARDs)/biological treatment use, self-efficacy, self-management, health-related quality of life, anxiety, coping efficacy, social support and disease activity were measured using validated tools. Descriptive statistics and effect sizes were calculated to determine clinically important (>0.3) changes. Peer mentor self-efficacy was assessed using a self-efficacy scale. Interviews conducted with participants examined acceptability and feasibility of procedures and outcome measures, as well as perspectives on the value of peer support for individuals with EIA. Themes were identified through constant comparison.Mentees experienced improvements in the overall arthritis impact on life, coping efficacy and social support (effect size >0.3). Mentees also perceived emotional, informational, appraisal and instrumental support. Mentors also reported benefits and learnt from mentees' fortitude and self-management skills. The training was well received by mentors. Their self-efficacy increased significantly after training completion. Participants' experience of peer support was informed by the unique relationship with their peer. All participants were unequivocal about the need for peer support for individuals with EIA.The intervention was well received. Training, peer support programme and outcome measures were demonstrated to be feasible with modifications. Early peer support may augment current rheumatological care.NCT01054963, NCT01054131.

Project description:Extensive studies have documented the complex and comprehensive psychosocial consequences of stroke. Psychosocial difficulties significantly affect long-term functioning and quality of life. Many studies have explored psychosocial interventions to prevent or treat psychosocial problems, but most have found modest effects. This study evaluated, from the perspective of adult stroke survivors, (1) the content, structure and process and (2) experienced usefulness of a dialogue-based psychosocial nursing intervention in primary care aimed at promoting psychosocial health and wellbeing.This was part of a feasibility study guided by the UK MRC complex interventions framework. It consisted of dialogue-based encounters with trained health professionals during approximately the first year poststroke. It was tested in two formats; individual or group encounters. Inclusion criteria were: Acute stroke, above 18 y.o., sufficient physical and cognitive functioning to participate. Data were collected immediately before, during and 14 days after the completion of the intervention. Pre- and post-data included medical and demographic data, quality of life, emotional wellbeing, life satisfaction, anxiety and depression. Qualitative interviews focusing on participant experiences were conducted two weeks following the intervention. Log notes taken by the health professionals conducting the intervention and work sheets filled in by participants also comprised data. Data analysis was case-oriented. The structured instruments were analysed regarding completeness of data and indication of changes in outcome variables. The qualitative interviews, log notes and work sheets were analysed using thematic content analysis.Twenty-five stroke survivors (17 men, 8 women), median age 64 (range 33-89), participated. Physical limitations varied from mild to severe. Seven participants had moderate to severe expressive aphasia. The participants found the content and process of the intervention relevant. Both the individual and group formats were found useful. Patients with aphasia reported that there were too few encounters (eight encounters were originally planned). The participants underscored the benefits of being supported through a difficult time, having a chance to tell and (re)create their story and being supported in their attempts to cope with the situation.This study provides initial support for the usefulness of the psychosocial intervention and highlights areas requiring further consideration and development.ClinicalTrials.gov Identifier: NCT01912014.

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.

Dataset Information

Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).

Publications

Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).

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