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Art as Creative Engagement for Stroke (ACES)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Creative Engagement Intervention
Portfolio Group
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Creative Engagement, Psychosocial, Art

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital
  • NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Creative Engagement Intervention

Portfolio Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Stroke Impact Scale

Secondary Outcome Measures

Positive and Negative Affect Schedule (PANAS)
Visual Analogue Self-Esteem Scale (VASES)

Full Information

First Posted
March 6, 2014
Last Updated
May 3, 2019
Sponsor
University of Dundee
Collaborators
University of Stirling, University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02085226
Brief Title
Art as Creative Engagement for Stroke
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee
Collaborators
University of Stirling, University of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Creative Engagement, Psychosocial, Art

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Creative Engagement Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Portfolio Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Creative Engagement Intervention
Other Intervention Name(s)
CEI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Portfolio Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Impact Scale
Time Frame
Assessed at end of intervention at 4 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Affect Schedule (PANAS)
Time Frame
Assessed at end of intervention at 4 weeks
Title
Visual Analogue Self-Esteem Scale (VASES)
Time Frame
Assessed at end of intervention at 4 weeks
Other Pre-specified Outcome Measures:
Title
Trait Hope Scale
Time Frame
Assessed at end of intervention at 4 weeks
Title
General Self Efficacy Scale
Time Frame
Assessed at end of intervention at 4 weeks
Title
Self-Efficacy for Art Scale
Time Frame
Assessed at end of intervention at 4 weeks
Title
Recovery Locus Of Control Scale (RLOC)
Time Frame
Assessed at end of intervention at 4 weeks
Title
Stroke Impact Scale
Time Frame
16 weeks
Title
Positive and Negative Affect Scale
Time Frame
16 weeks
Title
Visual Analogue Self-Esteem Scale
Time Frame
16 weeks
Title
Trait Hope Scale
Time Frame
16 weeks
Title
General Self-Efficacy Scale
Time Frame
16 weeks
Title
Self-Efficacy for Art Scale
Time Frame
16 weeks
Title
Recovery Locus of Control Scale
Time Frame
16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqui H Morris, PhD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Williams, PhD
Organizational Affiliation
University of Stirling
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thilo Kroll, PhD
Organizational Affiliation
University of Dundee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gillian Mead, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Donnan, PhD
Organizational Affiliation
University of Dundee
Official's Role
Study Chair
Facility Information:
Facility Name
NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital
City
Brechin
State/Province
Angus
ZIP/Postal Code
DD9 7QA
Country
United Kingdom
Facility Name
NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary
City
Perth
State/Province
Perth & Kinross
ZIP/Postal Code
PH1 1NX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26084571
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.
Results Reference
background
PubMed Identifier
25262168
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.
Results Reference
background
PubMed Identifier
28853296
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.
Results Reference
result

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Art as Creative Engagement for Stroke

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