HeART of Stroke: Randomised controlled parallel arm feasibility study of a community-based Arts & Health intervention compared with usual care to increase psychological wellbeing in people following stroke

Ellis-Hill, Caroline, Thomas, Sarah, Gracey, Fergus, Lamont-Robinson, Catherine, Cant, Robin, Marques, Elsa, Thomas, Peter, Grant, Mary, Nunn, Sam, Paling, Thomas, Thomas, Charlotte, Werson, Alessa, Galvin, Kathleen, Reynolds, Frances and Jenkinson, Damian (2019) HeART of Stroke: Randomised controlled parallel arm feasibility study of a community-based Arts & Health intervention compared with usual care to increase psychological wellbeing in people following stroke. BMJ Open, 9 (3). ISSN 2044-6055

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Abstract

Introduction People often experience distress following stroke due to fundamental challenges to their identity. Objectives To evaluate (1) the acceptability of ‘HeART of Stroke’ (HoS), a community-based arts and health group intervention, to increase psychological well-being; and (2) the feasibility of a definitive randomised controlled trial (RCT). Design Two-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding was attempted. Setting Community. Participants Community-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams. Interventions Artist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC. Outcomes The outcomes were self-reported measures of well-being, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and 5 months postrandomisation). Key feasibility parameters were gathered, data collection methods were piloted, and participant interviews (n=24) explored the acceptability of the intervention and study processes. Results Despite a low recruitment rate (14%; 95% CI 11% to 18%), 88% of the recruitment target was met, with 29 participants randomised to HoS and 27 to UC (57% male; mean (SD) age=70 (12.1) years; time since stroke=9 (6.1) months). Follow-up data were available for 47 of 56 (84%; 95% CI 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (National Health Service and societal perspectives). Five people declined HoS postrandomisation; of the remaining 24 who attended, 83% attended ≥6 sessions. Preliminary effect sizes for candidate primary outcomes were in the direction of benefit for the HoS arm. Participants found study processes acceptable. The intervention cost an estimated £456 per person and was well-received (no intervention-related serious adverse events were reported). Conclusions Findings from this first community-based study of an arts and health intervention for people poststroke suggest a definitive RCT is feasible. Recruitment methods will be revised. Trial registration number ISRCTN99728983.

Item Type: Article
Uncontrolled Keywords: feasibility study,identity,stroke,wellbeing,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 17 Oct 2018 08:30
Last Modified: 17 Jul 2020 23:37
URI: https://ueaeprints.uea.ac.uk/id/eprint/68563
DOI: 10.1136/bmjopen-2017-021098

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