Dataset Information

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.

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.

SUBMITTER: Ellis-Hill C

PROVIDER: S-EPMC6429750 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

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 Caroline C Thomas Sarah S Gracey Fergus F Lamont-Robinson Catherine C Cant Robin R Marques Elsa M R EMR Thomas Peter W PW Grant Mary M Nunn Samantha S Paling Thomas T Thomas Charlotte C Werson Alessa A Galvin Kathleen T KT Reynolds Frances F Jenkinson Damian D

BMJ open 20190308 3

<h4>Introduction</h4>People often experience distress following stroke due to fundamental challenges to their identity.<h4>Objectives</h4>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).<h4>Design</h4>Two-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre ...[more]

PMID: 30852528

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Dataset Information

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.

Introduction

Objectives

Design

Setting

Participants

Interventions

Outcomes

Results

Conclusions

Trial registration number

Publications

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.

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