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. 2019 Jan 25;20(1):80.
doi: 10.1186/s13063-018-2973-0.

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  1 , Eric Frison  2 , Fidéline Collin  2 , Piers Dawes  3 , Mark Hann  4 , Ines Himmelsbach  5 , Emma Hooper  1 , David Reeves  4 , Zoe Simkin  1 , Chryssoula Thodi  6 , Fan Yang  4 , Iracema Leroi  7 ; SENSE-Cog Trial Development Team
Collaborators, Affiliations

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 et al. Trials. .

Abstract

Background: Hearing 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.

Methods: This 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 registration: ISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.

Keywords: Dementia; Europe; Hearing; Psychosocial intervention; Quality of life; Sensory intervention; Vision.

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Conflict of interest statement

Authors’ information

JR was the study co-ordiantor at University of Manchester during SENSE-Cog field trial and RCT set-up.

Ethics approval and consent to participate

For Manchester, the study was reviewed by the NW Haydock ethics committee and received a favourable opinion on 21 December 2017 (version 1.0, 20 November 2017), 12 February 2018 (version 2.0, 10 January 2018) and 3 April 2018 (version 3.0 and current version, 22 January 2018) and has obtained the sponsor approval on 19 March 2018. For Nicosia, the study was reviewed by the Cyprus National Bioethics Committee and received a favourable opinion on 27 September 2016. For Athens, the study was reviewed by the Local Ethical Committee of Health Sciences and Scientific Committee of the Eginition Hospital of the National and Kapodistrian University of Athens ethics committee and received a favourable opinion on 24 January 2018. For Dublin, the study was reviewed on 26 September 2018 by the Saint James Hospital/AMNCH Research Ethics Committee. For Nice, the study was reviewed by the “Comité de Protection des personnes Sud Est I” and received a favourable opinion on 12 July 2018. Written consent will be collected from the participants eligible for the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The SENSE-Cog Randomised Controlled Trial Sensory Intervention: Support components delivered by the sensory support therapist
See this image and copyright information in PMC

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