Condition category
Circulatory System
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
16/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 don’t 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.

We’re 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 measures

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

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;

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

Sponsor information

Organisation

Royal Bournemouth Hospital (UK)

Sponsor details

Haematology
Bournemouth
BH7 7DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0212-27054

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26243555

Publication citations

Additional files

Editorial Notes

16/05/2016: Publication reference added.