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

Caroline Ellis-Hill, Sarah Thomas, Fergus Gracey, Catherine Lamont-Robinson, Robin Cant, Elsa Marques, Peter Thomas, Mary Grant, Sam Nunn, Thomas Paling, Charlotte Thomas, Alessa Werson, Kathleen Galvin, Frances Reynolds, Damian Jenkinson

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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.
Original languageEnglish
Article numbere021098
JournalBMJ Open
Volume9
Issue number3
DOIs
Publication statusPublished - 8 Mar 2019

Keywords

  • feasibility study
  • identity
  • stroke
  • wellbeing

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