Art as Creative Engagement for Stroke (ACES)

May 3, 2019 updated by: University of Dundee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Angus
      • Brechin, Angus, United Kingdom, DD9 7QA
        • NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital
    • Perth & Kinross
      • Perth, Perth & Kinross, United Kingdom, PH1 1NX
        • NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creative Engagement Intervention
Creative Engagement Intervention participants will receive 4-8 art sessions over 3-5 weeks, depending on length of inpatient stay. Sessions will be delivered as 1:1 sessions with the artist lasting up to one hour (depending on patient fatigue levels) and group sessions, with up to 5 participants, lasting up to two hours (depending on patient fatigue levels). Participant with receive one group and one individual session per week of inpatient stay. The sessions will cover 5 activity stages of the intervention, taking the participant through a progressive artwork development process. Participants will explore basic visual art materials and processes and progress to creating artworks with a personal context that they have directed and controlled.
Other: Creative Engagement Intervention

The CEI has 5 component stages which map the participant's journey with the Artist

  1. Meeting with Artist, discuss interests, stroke and explore initial creative goals.
  2. Introduction to materials and mark making to create interpretations of established images.
  3. From mark making and interpretations to developing personal project ideas.
  4. Turning personal project ideas into creative finished pieces.
  5. 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.

Other Names:
  • CEI
Placebo Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stroke Impact Scale
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Affect Schedule (PANAS)
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks
Visual Analogue Self-Esteem Scale (VASES)
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Trait Hope Scale
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks
General Self Efficacy Scale
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks
Self-Efficacy for Art Scale
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks
Recovery Locus Of Control Scale (RLOC)
Time Frame: Assessed at end of intervention at 4 weeks
Assessed at end of intervention at 4 weeks
Stroke Impact Scale
Time Frame: 16 weeks
16 weeks
Positive and Negative Affect Scale
Time Frame: 16 weeks
16 weeks
Visual Analogue Self-Esteem Scale
Time Frame: 16 weeks
16 weeks
Trait Hope Scale
Time Frame: 16 weeks
16 weeks
General Self-Efficacy Scale
Time Frame: 16 weeks
16 weeks
Self-Efficacy for Art Scale
Time Frame: 16 weeks
16 weeks
Recovery Locus of Control Scale
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

University of Edinburgh
University of Stirling

Investigators

  • Principal Investigator: Jacqui H Morris, PhD, University of Dundee
  • Study Chair: Brian Williams, PhD, University of Stirling
  • Study Chair: Thilo Kroll, PhD, University of Dundee
  • Study Chair: Gillian Mead, PhD, University of Edinburgh
  • Study Chair: Peter Donnan, PhD, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011GM01
  • CZH/4/720 (Other Grant/Funding Number: Chief Scientist Office, Scotland)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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