Ellis-Hill Caroline, Gracey Fergus, Thomas Sarah, Lamont-Robinson Catherine, Thomas Peter W, Marques Elsa M R, Grant Mary, Nunn Samantha, Cant Robin P I, Galvin Kathleen T, Reynolds Frances, Jenkinson Damian F
Faculty of Health and Social Sciences, Bournemouth University, Bournemouth, Dorset, UK.
Department of Clinical Psychology, University of East Anglia, Norwich, UK Oliver Zangwill Centre, Cambridgeshire Community Services NHS Trust, Ely, Cambridgeshire, UK.
BMJ Open. 2015 Aug 4;5(8):e008888. doi: 10.1136/bmjopen-2015-008888.
Over 152,000 people in the UK have strokes annually and a third experience residual disability. Low mood also affects a third of stroke survivors; yet psychological support is poor. While Arts for Health interventions have been shown to improve well-being in people with mild-to-moderate depression post-stroke, their role in helping people regain sense of self, well-being and confidence has yet to be evaluated. The main aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of an Arts for Health group intervention ('HeART of Stroke' (HoS)) for stroke survivors. HoS is a 10-session artist-facilitated group intervention held in the community over 14 weeks. It offers a non-judgemental, supportive environment for people to explore sense of self, potentially enhancing well-being and confidence.
Sixty-four people, up to 2 years post-stroke, recruited via secondary care research staff or community stroke/rehabilitation teams in two UK centres will be randomised to either HoS plus usual care or usual care only. Self-reported outcomes, measured at baseline and approximately 5 months postrandomisation, will include stroke-related, well-being, mood, self-esteem, quality of life and process measures. Analyses will focus on estimating key feasibility parameters (eg, rates of recruitment, retention, intervention attendance). We will develop outcome and resource use data collection methods to inform an effectiveness and cost-effectiveness analysis in the future trial. Interviews, with a sample of participants, will explore the acceptability of the intervention and study processes, as well as experiences of the HoS group.
National Health Service (NHS), Research and Development and University ethical approvals have been obtained. Two peer-reviewed journal publications are planned plus one service user led publication. Findings will be disseminated at key national conferences, local stakeholder events and via institutional websites.
ISRCTN99728983.
英国每年有超过15.2万人中风,其中三分之一会留下残疾。情绪低落也影响着三分之一的中风幸存者;然而心理支持却很匮乏。虽然健康艺术干预已被证明能改善中风后轻至中度抑郁症患者的幸福感,但它们在帮助人们恢复自我意识、幸福感和信心方面的作用尚未得到评估。本研究的主要目的是探讨开展一项实用的多中心随机对照试验的可行性,以评估健康艺术团体干预(“中风之心”(HoS))对中风幸存者的有效性和成本效益。HoS是一项由艺术家指导的为期10节的团体干预,在社区中进行,为期14周。它为人们提供了一个无评判、支持性的环境,以探索自我意识,有可能增强幸福感和信心。
通过英国两个中心的二级护理研究人员或社区中风/康复团队招募64名中风后2年内的患者,将其随机分为HoS加常规护理组或仅常规护理组。在基线和随机分组后约5个月测量的自我报告结果将包括与中风相关的、幸福感、情绪、自尊、生活质量和过程指标。分析将集中于估计关键的可行性参数(如招募率、保留率、干预参与率)。我们将开发结果和资源使用数据收集方法,以便为未来试验的有效性和成本效益分析提供信息。对部分参与者进行访谈,将探讨干预措施和研究过程的可接受性,以及HoS组的体验。
已获得国民保健服务(NHS)、研究与发展以及大学伦理批准。计划发表两篇同行评审的期刊文章以及一篇由服务使用者主导的文章。研究结果将在重要的全国性会议、当地利益相关者活动以及通过机构网站进行传播。
ISRCTN99728983。