A pilot economic evaluation of a feasibility trial for SUpporting wellbeing through PEeR-Befriending (SUPERB) for post-stroke aphasia.

OBJECTIVES: To explore the feasibility of a full economic evaluation of usual care plus peer-befriending versus usual care control, and potential cost-effectiveness of peer-befriending for people with aphasia. To report initial costs, ease of instruments' completion and overall data completeness. DESIGN: Pilot economic evaluation within a feasibility randomised controlled trial. SETTING: Community, England. PARTICIPANTS: People with post-stroke aphasia and low levels of psychological distress. INTERVENTION: All participants received usual care; intervention participants received six peer-befriending visits between randomisation and four months. MAIN MEASURES: Costs were collected on the stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care for participants and carers at 4- and 10-months post-randomisation. Health gains and costs were reported using the General Health Questionnaire-12 and the EQ-5D-5L. Mean (CI) differences for costs and health gains were reported and uncertainty represented using non-parametric bootstrapping and cost-effectiveness acceptability curves. RESULTS: 56 participants were randomised. Mean age was 70.1 (SD 13.4). Most (n = 37, 66%) had mild and many (n = 14; 25%) severe aphasia. There was ≥94% completion of CSRI questions. Peer-befriending was higher in intervention arm (p < 0.01) but there were no significant differences in total costs between trial arms. Peer-befriending visits costed on average £57.24 (including training and supervision costs). The probability of peer-befriending being cost-effective ranged 39% to 66%. CONCLUSIONS: Economic data can be collected from participants with post-stroke aphasia, indicating a full economic evaluation within a definitive trial is feasible. A larger study is needed to demonstrate further cost-effectiveness of peer-befriending.

SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia.

OBJECTIVE: To evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia. DESIGN: SUpporting 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. SETTING: Community. PARTICIPANTS: People 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. INTERVENTION: Peer-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 MEASURES: Metrics 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. RESULTS: All 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). CONCLUSION: Planning 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 NUMBER: NCT02947776.

'Emotion is of the essence. Number one priority': A nested qualitative study exploring psychosocial adjustment to stroke and aphasia.

BACKGROUND: Stroke and aphasia can have a profound impact on people's lives, and depression is a common, frequently persistent consequence. Social networks also suffer, with poor social support associated with worse recovery. It is essential to support psychosocial well-being post-stroke, and examine which factors facilitate successful adjustment to living with aphasia. AIMS: In the context of a feasibility randomized controlled trial of peer-befriending (SUPERB), this qualitative study explores adjustment for people with aphasia in the post-acute phase of recovery, a phase often neglected in previous research. METHODS & PROCEDURES: Semi-structured interviews were conducted with 20 people with aphasia and 10 significant others, who were purposively sampled from the wider group of 56 people with aphasia and 48 significant others. Interviews took place in participants' homes; they were analysed using framework analysis. OUTCOMES & RESULTS: Participants with aphasia were 10 women and 10 men; their median (interquartile range-IQR) age was 70 (57.5-77.0) years. Twelve participants had mild aphasia, eight moderate-severe aphasia. Significant others were six women and four men with a median (IQR) age of 70.5 (43-79) years. They identified a range of factors that influenced adjustment to aphasia post-stroke. Some were personal resources, including mood and emotions; identity/sense of self; attitude and outlook; faith and spirituality; and moving forward. Significant others also talked about the impact of becoming carers. Other factors were external sources of support, including familial and other relationships; doctors, nurses and hospital communication; life on the ward; therapies and therapists; psychological support, stroke groups; and community and socializing. CONCLUSIONS & IMPLICATIONS: To promote adjustment in the acute phase, hospital staff should prioritize the humanizing aspects of care provision. In the post-acute phase, clinicians play an integral role in supporting adjustment and can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy. What this paper adds What is already known on the subject Anxiety and depression are common consequences of stroke, with depression rates high at 33% at 1 year post-onset. There is evidence that the psychological needs of people with aphasia are even greater than those of the general stroke population. Social support and social networks are also negatively impacted. Few studies have examined adjustment when people are still in hospital or in the early stages of post-stroke life in the community (< 6 months). Further, many stroke studies exclude people with aphasia. What this paper adds to existing knowledge Adjustment to living with stroke and aphasia begins in the early stages of recovery. While this partly depends on personal resources, many factors depend on external sources of help and support. These include doctors, nurses and hospital communication, their experience of life on the ward, and their therapists' person-centred care. What are the potential or actual clinical implications of this work? Clinicians play an integral role in facilitating people with aphasia to utilize their personal resources and support systems to adjust to life after stroke. They can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy.

Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. DESIGN: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. PARTICIPANTS AND SETTING: People 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. INTERVENTION: Six 1-hour peer-befriending visits over three months. MAIN MEASURES: Feasibility 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. RESULTS: Of 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. CONCLUSIONS: SUPERB 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.

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

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.