title: 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.
abstract: BACKGROUND
  Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness.
  
  
  METHODS
  This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research.
  
  
  CONCLUSIONS
  If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation.
  
  
  BACKGROUND
  Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.
authors.affiliation: Social Dimensions of Health Institute, University of Dundee, 11 Airlie Place, Dundee DD1 4HJ, UK. j.y.morris@dundee.ac.uk.
authors.forename: Jacqui H
authors.initials: JH
authors.lastname: Morris
authors.forename: Chris
authors.initials: C
authors.lastname: Kelly
authors.forename: Madalina
authors.initials: M
authors.lastname: Toma
authors.forename: Thilo
authors.initials: T
authors.lastname: Kroll
authors.forename: Sara
authors.initials: S
authors.lastname: Joice
authors.forename: Gillian
authors.initials: G
authors.lastname: Mead
authors.forename: Peter
authors.initials: P
authors.lastname: Donnan
authors.forename: Brian
authors.initials: B
authors.lastname: Williams
mesh_terms: D000339:Affect; D001155:Art Therapy; D002985:Clinical Protocols; D003405:Creativity; D005240:Feasibility Studies; D006304:Health Status; D065026:Hope; D006801:Humans; D008603:Mental Health; D020127:Recovery of Function; D012107:Research Design; D012606:Scotland; D012649:Self Concept; D020377:Self Efficacy; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis / Q000523:psychology; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome