NCT02085226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

March 6, 2014

Last Update Submit

May 3, 2019

Conditions

Keywords

StrokeRehabilitationCreative EngagementPsychosocialArt

Outcome Measures

Primary Outcomes (1)

  • Stroke Impact Scale

    Assessed at end of intervention at 4 weeks

Secondary Outcomes (2)

  • Positive and Negative Affect Schedule (PANAS)

    Assessed at end of intervention at 4 weeks

  • Visual Analogue Self-Esteem Scale (VASES)

    Assessed at end of intervention at 4 weeks

Other Outcomes (11)

  • Trait Hope Scale

    Assessed at end of intervention at 4 weeks

  • General Self Efficacy Scale

    Assessed at end of intervention at 4 weeks

  • Self-Efficacy for Art Scale

    Assessed at end of intervention at 4 weeks

  • +8 more other outcomes

Study Arms (2)

Creative Engagement Intervention

EXPERIMENTAL

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

Portfolio Group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: CEI
Creative Engagement Intervention

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Stroke
  • Medically stable and referred for rehabilitation
  • Able to sit upright in chair
  • or more weeks of rehabilitation planned

You may not qualify if:

  • Diagnosis of Transient Ischemic Attack
  • Patinet in acute medical need
  • Patient unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital

Brechin, Angus, DD9 7QA, United Kingdom

Location

NHS Tayside, PRI Stroke Unit, Perth Royal Infirmary

Perth, Perth & Kinross, PH1 1NX, United Kingdom

Location

Related 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.

    PMID: 26084571BACKGROUND
  • 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.

    PMID: 25262168BACKGROUND
  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jacqui H Morris, PhD

    University of Dundee

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 12, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations