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对接受血液透析的终末期肾病患者实施基于艺术的干预措施:一项可行性研究方案

Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

作者信息

Carswell Claire, Reid Joanne, Walsh Ian, McAneney Helen, Noble Helen

机构信息

1School of Nursing and Midwifery, Queen's University Belfast, 97 Lisburn Road, Belfast, Northern Ireland.

2School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland.

出版信息

Pilot Feasibility Stud. 2019 Jan 5;5:1. doi: 10.1186/s40814-018-0389-y. eCollection 2019.

Abstract

BACKGROUND

End-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions.

METHODS

The aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT.

DISCUSSION

Arts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting.

TRIAL REGISTRATION

The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

摘要

背景

终末期肾病是一种改变生活的疾病。许多患者需要进行血液透析,这种治疗对生活质量和心理健康有深远影响。基于艺术的干预措施已在其他医疗环境中用于改善心理健康和生活质量;因此,它们可能有助于通过改善这些结果来应对血液透析的影响。然而,缺乏评估其在该人群中有效性的证据,并且很少有随机对照试验(RCT)评估基于艺术的复杂干预措施的有效性。

方法

本研究的目的是通过一项整群随机试点研究,确定针对接受血液透析的终末期肾病患者进行基于艺术的干预的整群RCT的可行性,通过过程评估探索该干预的可接受性,并探索经济评估的可行性。该研究将有三个阶段。第一阶段包括一项整群随机试点研究,以确定招募、参与和保留率。这将涉及招募30名参与者,他们将根据轮班模式通过整群随机化随机分配到实验组和对照组。第二阶段将是一项定性过程评估,以确定该干预在临床环境中的可接受性。这将涉及对13名患者进行半结构化访谈以及与医疗专业人员进行三个焦点小组讨论。第三阶段将是一项可行性经济评估,以确定在未来的整群RCT中进行数据收集的最佳方法。

讨论

基于艺术的干预措施已被证明可改善医疗环境中的生活质量,但缺乏评估针对接受血液透析患者的基于艺术的干预措施的证据。本研究旨在评估未来一项整群RCT的可行性,该RCT评估基于艺术的干预对接受血液透析患者的幸福感和心理健康的影响,并确定导致成功实施的关键因素。希望本研究将为一项试验提供信息,该试验可为血液透析环境中基于艺术的干预提供有力证据,从而影响未来的医疗政策。

试验注册

该试验于2018年8月14日在clinicaltrials.gov上进行前瞻性注册,注册号为NCT03629496。

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