Evidence map›Paper›PMID 30852528›Full record

Trial reportBMJ open2019

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.

Caroline Ellis-Hill, Sarah Thomas, Fergus Gracey, Catherine Lamont-Robinson, Robin Cant, Elsa M R Marques, Peter W Thomas, Mary Grant, Samantha Nunn, Thomas Paling and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Caroline Ellis-HillFaculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.
Sarah ThomasFaculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.ORCID 0000-0002-9501-9091
Fergus GraceyDepartment of Clinical Psychology, University of East Anglia, Norwich, UK.
Catherine Lamont-RobinsonSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Robin CantService User, (formerly of Canterbury Christ Church University), Canterbury, Kent, UK.
Elsa M R MarquesBristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-1360-5677
Peter W ThomasFaculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.
Mary GrantClinical Trials Unit, University of Warwick, Coventry, UK.
Samantha NunnThe Oliver Zangwill Centre for Neuropsychological Rehabilitation, Cambridgeshire Community Services NHS Trust, Ely, UK.
Thomas PalingBristol Medical School, University of Bristol, Bristol, UK.
Charlotte ThomasFaculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.
Alessa WersonDepartment of Clinical Psychology, University of East Anglia, Norwich, UK.
Kathleen T GalvinSchool of Health Sciences, University of Brighton, Brighton, UK.
Frances ReynoldsCollege of Health and Life Sciences, Brunel University London, Uxbridge, UK.
Damian JenkinsonStroke Unit, Dorset County Hospital, Dorchester, UK.

Funding

Department of Health PB-PG-0212-27054
6 · The paper itself

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. 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.

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 NUMBER: ISRCTN99728983.

Indexed as

Quality of LifeSelf ConceptStroke RehabilitationActivities of Daily LivingArt TherapyCost-Benefit AnalysisDelivery of Health CareFeasibility StudiesFemaleHumansIndependent LivingMalePatient Reported Outcome MeasuresPsychosocial Support SystemsStrokefeasibility studyidentitystrokewellbeing

Identifiers

PMID30852528
PMCPMC6429750

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.