A randomised controlled trial of hearing and vision support in dementia

protocol for a process evaluation in the SENSE-Cog trial

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

*Corresponding author for this work

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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.

Original languageEnglish
Article number223
Number of pages12
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 24 Feb 2020
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • process evaluation
  • complex intervention
  • dementia
  • sensory impairment
  • randomised controlled trial
  • hearing impairment
  • vision impairment
  • mediators
  • moderators
  • logic model

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    Leroi, I., Armitage, C. J., Collin, F., Frison, E., Hann, M., Hooper, E., ... SENSE-Cog Work Package 3 Investigators (2020). A randomised controlled trial of hearing and vision support in dementia: protocol for a process evaluation in the SENSE-Cog trial. Trials, 21(1), [223]. https://doi.org/10.1186/s13063-020-4135-4