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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: 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.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.If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation.Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.

SUBMITTER: Morris JH

PROVIDER: S-EPMC4190489 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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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.

Morris Jacqui H JH Kelly Chris C Toma Madalina M Kroll Thilo T Joice Sara S Mead Gillian G Donnan Peter P Williams Brian B

Trials 20140928

<h4>Background</h4>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.<h4>Methods/de ...[more]

PMID: 25262168

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Project description:Mild cognitive impairment (MCI) is associated with a higher risk of dementia and is becoming a topic of interest for pharmacological and nonpharmacological interventions. With advances in technology, computer-based cognitive exercises are increasingly integrated into traditional cognitive interventions, such as cognitive training. Another type of cognitive intervention involving technology use is cognitive engagement, consisting of involving participants in highly motivational and mentally challenging activities, such as learning to use a form of new digital technology. This study examined the feasibility and acceptability of a computerized cognitive stimulation (CCS) program and a computerized cognitive engagement (CCE) program, and then compared their effects in older adults with MCI.In this randomized study, data from 19 MCI patients were analyzed (n=9 in CCS and n=10 in CCE). The patients attended a group weekly session for a duration of 3 months. Assessments of cognitive and psychosocial variables were conducted at baseline (M0) and at the end of the programs (M3).All of the participants attended the 12 sessions and showed a high level of motivation. Attrition rate was very low (one dropout at M3 assessment). At M3, the CCS participants displayed a significant improvement in part B of the Trail Making Test (TMT-B; p=0.03) and self-esteem (p=0.005), while the CCE participants showed a significant improvement in part A of the Trail Making Test (TMT-A; p=0.007) and a higher level of technology acceptance (p=0.006). The two groups did not differ significantly (p>0.05) in cognitive and psychosocial changes after the intervention. However, medium effect sizes (Cohen's d=0.56; 95% CI =-0.43:1.55) were found on the free recall, favoring the CCS group, as well as on TMT-A (d=0.51; 95% CI =-0.48:1.49) and technology acceptance (d=-0.65; 95% CI =-1.64:0.34), favoring the CCE group.Both interventions were highly feasible and acceptable and allowed improvement in different aspects of cognitive and psychosocial functioning in MCI subjects.

Project description:BACKGROUND:The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used. METHODS:Clinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used. RESULTS:Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support. CONCLUSION:Recruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

Dataset Information

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.

Publications

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.

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