Contact information
Type
Scientific
Primary contact
Dr Caroline Ellis-Hill
ORCID ID
Contact details
Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
-
cehill@bournemouth.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16434
Study information
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
Acronym
HeART of Stroke project V1
Study hypothesis
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
13/SW/0136
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type, Community study
Intervention
Arts for Health group, 10 sessions over 16 weeks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Wellbeing - Warwick-Edinburgh Mental Wellbeing Scale;
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2014
Overall trial end date
01/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 64; UK Sample Size: 64;
Total final enrolment
56
Participant 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
Recruitment start date
01/05/2014
Recruitment end date
01/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal London House
Bournemouth
BH1 3LT
United Kingdom
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme; Grant Codes: PB-PG-0212-27054
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26243555
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/30852528 (added 13/03/2020)