A feasibility study of a randomised controlled trial of an Arts for Health group intervention (HeART of stroke) to support self-confidence and psychological wellbeing following a stroke

ISRCTN	ISRCTN99728983
DOI	https://doi.org/10.1186/ISRCTN99728983
Secondary identifying numbers	16434

Submission date: 03/04/2014
Registration date: 03/04/2014
Last edited: 13/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Caroline Ellis-Hill
Scientific

Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom

Email	cehill@bournemouth.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A feasibility study of a randomised controlled trial of an Arts for Health group intervention (HeART of stroke) to support self-confidence and psychological wellbeing following a stroke
Study acronym	HeART of Stroke project V1
Study objectives	How feasible is it to test the effectiveness of an Arts for Health group following stroke? Stroke can have a major impact on the individual, physically, and also psychologically in terms of sense of self and identity. While talking therapies (such as counselling) may help they dont suit everyone, especially those with communication difficulties, who make up a third of people following stroke. In an Arts for Health (AfH) approach, people work alongside an artist in small groups and are supported to feel safe to express themselves through creative activity without needing words. Were interested in exploring whether an AfH intervention (HeART of Stroke) offers an acceptable way for stroke survivors to explore their new sense of self alongside others. To see if it could be a beneficial addition to standard stroke care offering value for money, we need to carry out a large study. To make sure that such a study is possible we are carrying out a smaller feasibility study. In this feasibility study 64 people up to one year post stroke will take part (32 from the Royal Bournemouth Hospital and 32 from Cambridge Community Services). They will be randomly assigned to attend a 10 session AfH group held in the community or to continue with their usual care. At the study start and end we will ask participants to complete a questionnaire booklet (with support if needed) about wellbeing, mood, quality of life, confidence and use of medication, health, social care and informal support. We will also interview some participants about their experiences of taking part, collect feedback from the artists delivering the intervention and information about the cost of providing AfH groups. This will help us to find out if a large national study is possible, and if it is, to help us to plan it.
Ethics approval(s)	13/SW/0136
Health condition(s) or problem(s) studied	Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type, Community study
Intervention	Arts for Health group, 10 sessions over 16 weeks
Intervention type	Other
Primary outcome measure	Wellbeing - Warwick-Edinburgh Mental Wellbeing Scale;
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2014
Completion date	01/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 64; UK Sample Size: 64;
Total final enrolment	56
Key inclusion criteria	1. Patient of a) Royal Bournemouth Hospital OR b) Cambridgeshire Community Services 2. Diagnosis of stroke 3. 18 years of age or above 4. Physical, communication, or cognitive symptoms from stroke at five days post stroke 5. Be able to provide informed consent 6. Up to 1 year post stroke
Key exclusion criteria	1. Cognitive levels such that an individual would be unable to comprehend the consenting process and the intervention 2. Severe receptive aphasia which means that the person will not be able to comprehend the consenting process and the intervention 3. Already receiving a psychiatric or clinical psychology intervention We do not feel that people with long term competing health needs will benefit from this particular short term programme 4. Not being able to go to the toilet independently (this would not exclude people who use catheters /pads). This is because the artist will not be trained to assist them in the bathroom 5. Living in a residential/nursing home. An important group for a future study
Date of first enrolment	01/05/2014
Date of final enrolment	01/08/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal London House

Bournemouth
BH1 3LT
United Kingdom

Sponsor information

Royal Bournemouth Hospital (UK)
Hospital/treatment centre

Haematology
Bournemouth
BH7 7DW
England
United Kingdom

"ROR"	https://ror.org/01v14jr37

Funders

Funder type

Government

Research for Patient Benefit Programme; Grant Codes: PB-PG-0212-27054
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	04/08/2015		Yes	No
Results article	results	08/03/2019	13/03/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

13/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
14/01/2019: No publications found, verifying study status with principal investigator.
16/05/2016: Publication reference added.