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HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke.

Ellis-Hill, C., Thomas, S., Gracey, F., Lamont-Robinson, C., Cant, R., Marques, E., Thomas, P, Grant, M., Nunn, S., Paling, T., Thomas, C., Werson, A., Galvin, K. T., Reynolds, F. and Jenkinson, D., 2019. HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke. BMJ Open, 9, e021098.

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DOI: 10.1136/bmjopen-2017-021098

Abstract

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.

Item Type:Article
ISSN:2044-6055
Additional Information:Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) programme (Grant Reference Number PB-PG-0212-27054). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. This study is included in the National Institute of Health Research Clinical Research Network (NIHR CRN) portfolio. We were awarded funding from the NIHR-SRN Rehabilitation Clinical Subgroup to bring the research team together and prepare the grant application. FG was supported by NIHR Flexibility and Sustainability Funding via Cambridgeshire Primary Care Trust R&D Department.
Group:Faculty of Health & Social Sciences
ID Code:32027
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:11 Mar 2019 14:49
Last Modified:11 Mar 2019 14:49

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