Objectives Evaluate: (i) the acceptability of ‘HeART of Stroke’ (HoS), a community-based Arts & Health group intervention, to increase psychological wellbeing; (ii) the feasibility of a definitive randomised controlled trial (RCT).
Design Two-centre 24-month parallel arm RCT with qualitative and economic components. Randomisation stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding attempted.
Participants Community-dwelling adults ≤ 2 years post-stroke, recruited via hospital clinical teams/databases or community stroke/rehabilitation teams.
Interventions Artist-facilitated Arts & Health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC.
Outcomes Self-reported measures of wellbeing, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and five months post-randomisation). Key feasibility parameters were gathered, data collection methods piloted and participant interviews (n=24) explored acceptability of the intervention/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 47/56 (84%; 95% CI: 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (NHS and societal perspectives). Five people declined HoS post-randomisation; 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 reported).
Conclusions Findings from this first community-based study of an Arts & Health intervention for people post-stroke suggest a definitive RCT is feasible. Recruitment methods will be revised.