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Ellis-Hill, Caroline, Thomas, Sarah, Gracey, Fergus 
ORCID: https://orcid.org/0000-0002-1416-7894, 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),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 17 Oct 2018 08:30 |
| Last Modified: | 19 Oct 2023 02:07 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/68563 |
| DOI: | 10.1136/bmjopen-2017-021098 |
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