Evidence map›Paper›PMID 30683150›Full record

ArticleTrials2019

Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial.

Jemma Regan, Eric Frison, Fidéline Collin, Piers Dawes, Mark Hann, Ines Himmelsbach, Emma Hooper, David Reeves, Zoe Simkin, Chryssoula Thodi and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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  8. Enablers and Barriers to Hearing aid Use in People Living With Dementia.Journal of applied gerontology : the official journal of the Southern Gerontological Society · 2024
    Article
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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

13 authors.

Jemma ReganDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Oxford Road, Manchester, M13 9PL, UK.
Eric FrisonUniversity of Bordeaux, INSERM, EUCLID/F-CRIN Clinical Trials Platform, Bordeaux Population Health Center, CHU Bordeaux, F-33000, Bordeaux, France.
Fidéline CollinUniversity of Bordeaux, INSERM, EUCLID/F-CRIN Clinical Trials Platform, Bordeaux Population Health Center, CHU Bordeaux, F-33000, Bordeaux, France.
Piers DawesManchester Centre for Audiology and Deafness (ManCAD) University of Manchester and the Manchester Academic Health Sciences Centre, Oxford Road, Manchester, M13 9PL, UK.
Mark HannDivision of Population Health, Health Services Research & Primary Care, University of Manchester, Grafton Street, Manchester, M12 9NT, UK.
Ines HimmelsbachInstitute of Applied Research, Development and Continuing Education, Catholic University of Applied Sciences, Karlstraße 63, Freiburg, 79104, Germany.
Emma HooperDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Oxford Road, Manchester, M13 9PL, UK.
David ReevesDivision of Population Health, Health Services Research & Primary Care, University of Manchester, Grafton Street, Manchester, M12 9NT, UK.
Zoe SimkinDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Oxford Road, Manchester, M13 9PL, UK.
Chryssoula ThodiSchool of Sciences, Department of Health Sciences, European University Cyprus, Diogenis Street, Nicosia, 2404, Cyprus.
Fan YangDivision of Population Health, Health Services Research & Primary Care, University of Manchester, Grafton Street, Manchester, M12 9NT, UK.
Iracema LeroiDivision of Neuroscience and Experimental Psychology, University of Manchester and the Manchester Academic Health Sciences Centre, Oxford Road, Manchester, M13 9PL, UK. iracema.leroi@manchester.ac.uk.
SENSE-Cog Trial Development Team

Funding

Horizon 2020 668648
6 · The paper itself

Abstract

backgroundHearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions.

methodsThis is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness. DISCUSSION: This is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment.

trial registrationISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.

Indexed as

Pragmatic Clinical Trials as TopicQuality of LifeAgedAged, 80 and overCost-Benefit AnalysisDementiaHearing DisordersHumansInformed ConsentMulticenter Studies as TopicOutcome Assessment, Health CarePatient SelectionSample SizeVision DisordersDementiaEuropeHearingPsychosocial interventionQuality of lifeSensory interventionVision

Identifiers

PMID30683150
PMCPMC6347775

What OpenQuestion holds

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Registered trials

None linked

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.