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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: | Ellis-Hill, C., Thomas, S., Gracey, F., Lamont-Robinson, C., Cant, R., Marques, E.M.R., Thomas, P.W., 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 (3), e021098, pp. 1 - 17. doi: 10.1136/bmjopen-2017-021098. |
Abstract: | Copyright © Author(s) (or their employer(s)) 2019. 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. |
URI: | https://bura.brunel.ac.uk/handle/2438/17742 |
DOI: | https://doi.org/10.1136/bmjopen-2017-021098 |
Appears in Collections: | Dept of Health Sciences Research Papers |
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