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, 2019 03 08.
Article
em En
| MEDLINE
| ID: mdl-30852528
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Métodos Terapêuticos e Terapias MTCI:
Terapias_mente_y_cuerpo
Assunto principal:
Arteterapia
/
Qualidade de Vida
/
Autoimagem
/
Acidente Vascular Cerebral
/
Reabilitação do Acidente Vascular Cerebral
Tipo de estudo:
Clinical_trials
/
Qualitative_research
/
Sysrev_observational_studies
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido