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Trials. 2020 Feb 24;21(1):223. doi: 10.1186/s13063-020-4135-4.

A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial.

Author information

1
Global Brain Health Institute, School of Medicine, Trinity College Dublin, Trinity College Institute of Neurosciences, Room 0.60, Lloyd Building, Dublin 2, Ireland. iracema.leroi@tcd.ie.
2
Division of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester, UK. iracema.leroi@tcd.ie.
3
Manchester Centre for Health Psychology, School of Psychological Sciences, University of Manchester, Manchester, UK.
4
Bordeaux Population Health Center, Univ. Bordeaux, INSERM, EUCLID/F-CRIN Clinical Trials Platform, CHU Bordeaux, F-33000, Bordeaux, France.
5
Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.
6
Division of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester, UK.
7
Institute of Applied Research, Development and Continuing Education, Catholic University of Applied Sciences, Freiburg, Germany.

Abstract

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.

KEYWORDS:

Complex intervention; Dementia; Hearing impairment; Logic model; Mediators; Moderators; Process evaluation; Randomised controlled trial; Sensory impairment; Vision impairment

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