Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2013-07-31
2014-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically stable and referred for rehabilitation
* Able to sit upright in chair
* 3 or more weeks of rehabilitation planned
Exclusion Criteria
* Patinet in acute medical need
* Patient unable to provide informed consent
ALL
No
Sponsors
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University of Stirling
OTHER
University of Edinburgh
OTHER
University of Dundee
OTHER
Responsible Party
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Principal Investigators
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Jacqui H Morris, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Brian Williams, PhD
Role: STUDY_CHAIR
University of Stirling
Thilo Kroll, PhD
Role: STUDY_CHAIR
University of Dundee
Gillian Mead, PhD
Role: STUDY_CHAIR
University of Edinburgh
Peter Donnan, PhD
Role: STUDY_CHAIR
University of Dundee
Locations
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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, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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CZH/4/720
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2011GM01
Identifier Type: -
Identifier Source: org_study_id
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