Art as Creative Engagement for Stroke

Stroke Clinical Trial

— ACES  

Official title:

Can an Arts Based Creative Engagement Intervention Following Stroke Improve Psychosocial Outcomes? A Feasibility Trial of a Creative Engagement Intervention for In-patient Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085226
• Other study ID #: 2011GM01
• Secondary ID: CZH/4/720
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following stroke improve psychosocial outcomes? A feasibility trial of a creative engagement intervention for inpatient rehabilitation.

This is a feasibility randomised controlled trial of a novel intervention for stroke rehabilitation examining effects of participation in visual arts activities on psychosocial outcomes after stroke.

The investigators hypothesise that participation in a visual arts based intervention (CEI) will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving in-patient rehabilitation compared to viewing a portfolio of artwork.

The results of the study will inform a sample size calculation for a full trial.

Description:

SUMMARY

Background: Stroke is the main cause of complex adult disability in Britain. Stroke rehabilitation is typically task orientated, focusing on physical and functional independence. Psychosocial consequences of stroke are serious and mediate recovery, influencing family relationships, community reintegration and quality of life. Therefore, improving psychosocial outcomes after stroke could improve overall recovery.

Creative arts programmes are increasingly used to address psychosocial outcomes in long-term and mental health conditions. These programmes focus on positive influences of engagement in creative art activities facilitated by artists. However, there is little research into effects of creative engagement on psychosocial outcomes after stroke.

Objectives: The purpose of this study is to:

Conduct a feasibility randomised controlled trial (RCT) to test the effects of a participatory visual arts intervention compared to art viewing on psychosocial outcomes following stroke in order to assess effect size for sample size calculation in a full RCT.

The effects of the CEI will be examined in a randomised controlled feasibility trial, which will be run at two stroke rehabilitation units in NHS Tayside and will explore the impact of the intervention on a range of psychosocial outcomes.

Patients meeting inclusion criteria will be randomised to a CEI group or an attention control group. The CEI group will receive a visual arts intervention of 4-8 sessions during in-patient rehabilitation. The control group will receive an art portfolio to view after randomisation and baseline assessment, with information about community opportunities to engage in art. The groups will be compared on selected psychosocial outcomes. Findings will indicate the potential magnitude and direction of change to allow for sample size requirements in development of a subsequent randomised control trial to examine effectiveness of the CEI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Stroke

• Medically stable and referred for rehabilitation

• Able to sit upright in chair

• 3 or more weeks of rehabilitation planned

Exclusion Criteria:

• Diagnosis of Transient Ischemic Attack

• Patinet in acute medical need

• Patient unable to provide informed consent

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Creative Engagement Intervention
The CEI has 5 component stages which map the participant's journey with the Artist Meeting with Artist, discuss interests, stroke and explore initial creative goals. Introduction to materials and mark making to create interpretations of established images. From mark making and interpretations to developing personal project ideas. Turning personal project ideas into creative finished pieces. Review of completed work, mounting and display of work, future plans. It is recognised that participants will progress differently. Components may be repeated or retuned to or may be addressed simultaneously. Participants may progress rapidly and so move from stage 5 back to stages 2, 3 or 4 to progress new work or experience new materials or processes.
• Portfolio Group
The Portfolio group will receive conventional rehabilitation activity at each site. In addition, to control for effects of art related attention received by the intervention group, after baseline assessment and randomisation, this group will receive from the research assistant, a portfolio of work produced by previous participants of the Tayside CEI, with details of community programmes that people with stroke can attend after hospital discharge. Participants will be invited to view the portfolio during their stay. Prior to outcome assessment, the research assistant will visit participants again to answer questions and to discuss options for community programmes, if the person is interested.

Locations

Country	Name	City	State
United Kingdom	NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital	Brechin	Angus
United Kingdom	NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary	Perth	Perth & Kinross

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	University of Edinburgh, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Morris J, Toma M, Kelly C, Joice S, Kroll T, Mead G, Williams B. Social context, art making processes and creative output: a qualitative study exploring how psychosocial benefits of art participation during stroke rehabilitation occur. Disabil Rehabil. 2016;38(7):661-72. doi: 10.3109/09638288.2015.1055383. Epub 2015 Jun 18. — View Citation

Morris JH, Kelly C, Joice S, Kroll T, Mead G, Donnan P, Toma M, Williams B. Art participation for psychosocial wellbeing during stroke rehabilitation: a feasibility randomised controlled trial. Disabil Rehabil. 2019 Jan;41(1):9-18. doi: 10.1080/09638288.2 — View Citation

Morris JH, Kelly C, Toma M, Kroll T, Joice S, Mead G, Donnan P, Williams B. Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study. Trials. 2014 Sep 28;15:380. doi: 10.1186/1745-6215-15-380. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trait Hope Scale		Assessed at end of intervention at 4 weeks
Other	General Self Efficacy Scale		Assessed at end of intervention at 4 weeks
Other	Self-Efficacy for Art Scale		Assessed at end of intervention at 4 weeks
Other	Recovery Locus Of Control Scale (RLOC)		Assessed at end of intervention at 4 weeks
Other	Stroke Impact Scale		16 weeks
Other	Positive and Negative Affect Scale		16 weeks
Other	Visual Analogue Self-Esteem Scale		16 weeks
Other	Trait Hope Scale		16 weeks
Other	General Self-Efficacy Scale		16 weeks
Other	Self-Efficacy for Art Scale		16 weeks
Other	Recovery Locus of Control Scale		16 weeks
Primary	Stroke Impact Scale		Assessed at end of intervention at 4 weeks
Secondary	Positive and Negative Affect Schedule (PANAS)		Assessed at end of intervention at 4 weeks
Secondary	Visual Analogue Self-Esteem Scale (VASES)		Assessed at end of intervention at 4 weeks