1. 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
- Author
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Catherine Lamont-Robinson, Alessa Werson, Peter Thomas, Robin P I Cant, Thomas Paling, Sarah Thomas, Mary Grant, Samantha Nunn, Charlotte Thomas, Caroline Ellis-Hill, Kathleen Galvin, Elsa Marques, Frances Reynolds, Fergus Gracey, and Damian Jenkinson
- Subjects
Male ,medicine.medical_specialty ,Blinding ,Cost-Benefit Analysis ,medicine.medical_treatment ,Psychological intervention ,Health intervention ,law.invention ,03 medical and health sciences ,wellbeing ,0302 clinical medicine ,Quality of life (healthcare) ,Randomized controlled trial ,law ,Activities of Daily Living ,medicine ,Humans ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Stroke ,identity ,Rehabilitation ,business.industry ,Research ,Psychosocial Support Systems ,Stroke Rehabilitation ,feasibility study ,Art Therapy ,General Medicine ,medicine.disease ,stroke ,Self Concept ,Mood ,Quality of Life ,Physical therapy ,Feasibility Studies ,Female ,Health Services Research ,Independent Living ,business ,Delivery of Health Care ,030217 neurology & neurosurgery - Abstract
IntroductionPeople often experience distress following stroke due to fundamental challenges to their identity.ObjectivesTo 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).DesignTwo-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.SettingCommunity.ParticipantsCommunity-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams.InterventionsArtist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC.OutcomesThe 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.ResultsDespite 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).ConclusionsFindings 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 numberISRCTN99728983.
- Published
- 2019