Morris Jacqui H, Kelly Chris, Toma Madalina, Kroll Thilo, Joice Sara, Mead Gillian, Donnan Peter, Williams Brian
Social Dimensions of Health Institute, University of Dundee, 11 Airlie Place, Dundee DD1 4HJ, UK.
Trials. 2014 Sep 28;15:380. doi: 10.1186/1745-6215-15-380.
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/DESIGN: 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.
中风后参与艺术活动的益处日益受到认可。定性研究表明，中风后康复期间参与视觉艺术创作性参与干预（CEIs）可能改善情绪、自尊、希望以及身体恢复的某些方面。本研究旨在检验在住院中风康复中由艺术家开展CEI随机对照试验的可行性，以测试其有效性。
方法/设计：本试验是一项在住院中风康复中进行的双臂、单盲、随机对照可行性试验。我们将在苏格兰一个卫生委员会区域的两个中风单元招募80名接受中风康复治疗的患者（每组40名）。干预组参与者将接受由经验丰富的艺术家提供的基于视觉艺术的CEI。艺术家将遵循一个具有特定组成部分的干预方案，使参与者能够设定、实现和回顾艺术目标。参与者将接受多达八次干预课程，四次小组课程和四次与艺术家的一对一课程。对照组参与者将仅接受常规护理。数据收集将在基线、干预后和三个月随访时进行。与中风相关的健康状况是主要结果；情绪、自尊、自我效能感、感知恢复控制和希望是次要结果。将对有目的地挑选的患者、艺术家和医护人员进行半结构化访谈，以了解他们对干预措施的看法和体验，以及试验过程的可行性和可接受性。还将收集招募率、留存率以及患者对艺术参与的偏好。数据将以置信区间表明选择或拒绝参与CEI的患者比例，并将允许计算未来确定性试验的招募率。汇总数据将表明组间差异的潜在变异性、大小和方向。研究结果将为确定性试验的样本量计算提供信息。定性数据的主题分析将使用框架方法进行管理。框架是一种用于定性数据的分析方法，常用于政策和医学研究。
如果该干预措施被证明有效果，它有可能解决中风恢复中以前未在康复中常规解决的方面。
于2014年3月6日在ClinicalTrials.Gov注册，注册号为NCT02085226。
