Evidence map›Paper›PMID 32093757›Full record

ArticleTrials2020

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

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Iracema LeroiGlobal 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.ORCID http://orcid.org/0000-0003-1822-3643
Christopher J ArmitageManchester Centre for Health Psychology, School of Psychological Sciences, University of Manchester, Manchester, UK.
Fidéline CollinBordeaux Population Health Center, Univ. Bordeaux, INSERM, EUCLID/F-CRIN Clinical Trials Platform, CHU Bordeaux, F-33000, Bordeaux, France.
Eric FrisonBordeaux Population Health Center, Univ. Bordeaux, INSERM, EUCLID/F-CRIN Clinical Trials Platform, CHU Bordeaux, F-33000, Bordeaux, France.
Mark HannDivision of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.
Emma HooperDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester, UK.
David ReevesDivision of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.
Zoe SimkinDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester, UK.
Lucas WolskiInstitute of Applied Research, Development and Continuing Education, Catholic University of Applied Sciences, Freiburg, Germany.
SENSE-Cog Work Package 3 Investigators

Funding

Horizon 2020 research and innovation programme 668648
6 · The paper itself

Abstract

backgroundOptimising 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/

designWe 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 registrationISRCTN, ISRCTN17056211. Registered on 19 February 2018.

Indexed as

DementiaHearing DisordersVision DisordersHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicComplex interventionDementiaHearing impairmentLogic modelMediatorsModeratorsProcess evaluationRandomised controlled trialSensory impairmentVision impairment

Identifiers

PMID32093757
PMCPMC7041097

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.