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Title: 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.
Authors: Ellis-Hill, C
Thomas, S
Gracey, F
Lamont-Robinson, C
Cant, R
Marques, EMR
Thomas, PW
Grant, M
Nunn, S
Paling, T
Thomas, C
Werson, A
Galvin, KT
Reynolds, F
Jenkinson, D
Issue Date: 8-Mar-2019
Publisher: BMJ Publishing Group
Citation: BMJ open, 2019, 9 (3), pp. e021098 - ?
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.
ISSN: 2044-6055
Appears in Collections:Dept of Clinical Sciences Research Papers

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