A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial.
Complex intervention
Dementia
Hearing impairment
Logic model
Mediators
Moderators
Process evaluation
Randomised controlled trial
Sensory impairment
Vision impairment
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
24 Feb 2020
24 Feb 2020
Historique:
received:
23
07
2019
accepted:
03
02
2020
entrez:
26
2
2020
pubmed:
26
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
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. 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. 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. ISRCTN, ISRCTN17056211. Registered on 19 February 2018.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ISRCTN, ISRCTN17056211. Registered on 19 February 2018.
Identifiants
pubmed: 32093757
doi: 10.1186/s13063-020-4135-4
pii: 10.1186/s13063-020-4135-4
pmc: PMC7041097
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
223Subventions
Organisme : Horizon 2020 research and innovation programme
ID : 668648
Investigateurs
Harvey Abrams
(H)
Nathalie Chaghil-Boissière
(N)
Anna Pavlina Charalambous
(AP)
Fidéline Collin
(F)
Fofi Constantinidou
(F)
Lisa Crosby
(L)
Piers Dawes
(P)
Eric Frison
(E)
Camille Gilbert
(C)
Mark Hann
(M)
Emma Hooper
(E)
Ines Himmelsbach
(I)
Evangelia Kontogianni
(E)
Brian Lawlor
(B)
Iracema Leroi
(I)
Sarah Marie
(S)
Susana Montecelo
(S)
Antonios Politis
(A)
Otilia Postea
(O)
David Reeves
(D)
David Renaud
(D)
Zoe Simkin
(Z)
Monique Termote
(M)
Chryssoula Thodi
(C)
Lucas Wolski
(L)
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