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Published in: Trials 1/2020

Open Access 01-12-2020 | Dementia | Study protocol

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

Authors: Iracema Leroi, Christopher J. Armitage, Fidéline Collin, Eric Frison, Mark Hann, Emma Hooper, David Reeves, Zoe Simkin, Lucas Wolski, on behalf of the SENSE-Cog Work Package 3 Investigators

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
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Metadata
Title
A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial
Authors
Iracema Leroi
Christopher J. Armitage
Fidéline Collin
Eric Frison
Mark Hann
Emma Hooper
David Reeves
Zoe Simkin
Lucas Wolski
on behalf of the SENSE-Cog Work Package 3 Investigators
Publication date
01-12-2020
Publisher
BioMed Central
Keywords
Dementia
Dementia
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4135-4

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