一项痴呆症听力和视力支持的随机对照试验：SENSE-Cog 试验的过程评估方案。
A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial.
机构信息
Global Brain Health Institute, School of Medicine, Trinity College Dublin, Trinity College Institute of Neurosciences, Room 0.60, Lloyd Building, Dublin 2, Ireland.
Division of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester, UK.
出版信息
Trials. 2020 Feb 24;21(1):223. doi: 10.1186/s13063-020-4135-4.
BACKGROUND
Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT.
METHODS/DESIGN: We will use a mixed methods approach with a theoretical framework derived from the UK Medical Research Council's' guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes.
DISCUSSION
This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment.
TRIAL REGISTRATION
ISRCTN, ISRCTN17056211. Registered on 19 February 2018.
背景
优化听力和视力功能可能对改善痴呆症患者（PwD）及其陪伴者的一系列结局至关重要。SENSE-Cog 跨国家随机对照试验（RCT）正在评估一项感官干预（SI）的有效性，该干预旨在改善 5 个欧洲国家中同时存在听力和/或视力障碍的 PwD 的生活质量。为了确定干预措施将如何或为何会达到或未达到预期的结果，我们设计了一项过程评估，以探索预期结果与实际结果之间可能存在的差异。这也将帮助我们了解背景因素如何影响结果。本文描述了该过程评估的方案，该评估嵌入在 RCT 中。
方法/设计：我们将采用混合方法，理论框架来源于英国医学研究理事会关于过程评估的指南。它将包括以下内容：（1）评估干预措施的关键方面将如何实施，这对于将干预措施推广到现实人群中非常重要；（2）描述可能影响干预措施在不同国家实施和影响的背景问题；（3）通过分析潜在的调节因素和中介因素，研究可能的因果机制。为了避免偏倚，我们将在分析主要有效性结果之前分析过程数据。
讨论
这项评估将深入了解在不同的欧洲背景下，复杂的 SENSE-Cog SI 将如何进行调整、实施和接受，这些背景都有独特的卫生和社会保健经济。研究结果将深入了解影响变化的因果机制，并确定我们是否应该在更广泛的范围内对 PwD 和并发感觉障碍实施该干预措施，如果有效的话。
试验注册
ISRCTN，ISRCTN82161211。于 2018 年 2 月 19 日注册。
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