Clinical trial NCT02085226: Art as Creative Engagement for Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Creative Engagement
Psychosocial
Art
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: University of Edinburgh
First posted: 2014-03-12
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroke Impact Scale
timeFrame: Assessed at end of intervention at 4 weeks
Secondary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Assessed at end of intervention at 4 weeks
measure: Visual Analogue Self-Esteem Scale (VASES)
timeFrame: Assessed at end of intervention at 4 weeks
Other outcomes:
measure: Trait Hope Scale
timeFrame: Assessed at end of intervention at 4 weeks
measure: General Self Efficacy Scale
timeFrame: Assessed at end of intervention at 4 weeks
measure: Self-Efficacy for Art Scale
timeFrame: Assessed at end of intervention at 4 weeks
measure: Recovery Locus Of Control Scale (RLOC)
timeFrame: Assessed at end of intervention at 4 weeks
measure: Stroke Impact Scale
timeFrame: 16 weeks
measure: Positive and Negative Affect Scale
timeFrame: 16 weeks
measure: Visual Analogue Self-Esteem Scale
timeFrame: 16 weeks
measure: Trait Hope Scale
timeFrame: 16 weeks
measure: General Self-Efficacy Scale
timeFrame: 16 weeks
measure: Self-Efficacy for Art Scale
timeFrame: 16 weeks
measure: Recovery Locus of Control Scale
timeFrame: 16 weeks
Locations:
city: Brechin
country: United Kingdom
facility: NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital
state: Angus
city: Perth
country: United Kingdom
facility: NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary
state: Perth & Kinross
Study officials:
affiliation: University of Dundee
name: Jacqui H Morris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stirling
name: Brian Williams, PhD
role: STUDY_CHAIR
affiliation: University of Dundee
name: Thilo Kroll, PhD
role: STUDY_CHAIR
affiliation: University of Edinburgh
name: Gillian Mead, PhD
role: STUDY_CHAIR
affiliation: University of Dundee
name: Peter Donnan, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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: 10.1080/09638288.2017.1370499. Epub 2017 Aug 30.