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 |
| Protocol serial number | 16434 |
| Sponsor | Royal Bournemouth Hospital (UK) |
| Funder | Research for Patient Benefit Programme; Grant Codes: PB-PG-0212-27054 |
- 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
Scientific
Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
| cehill@bournemouth.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Wellbeing - Warwick-Edinburgh Mental Wellbeing Scale; |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal London House
Bournemouth
BH1 3LT
United Kingdom
BH1 3LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/03/2019 | 13/03/2020 | Yes | No |
| Protocol article | protocol | 04/08/2015 | 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.
