Cognitive aids for people with early stage dementia versus treatment as usual (Dementia Early Stage Cognitive Aids New Trial (DESCANT)): study protocol for a randomised controlled trial

Chester, Helen; Clarkson, Paul; Davies, Linda; Hughes, Jane; Islam, Muhammad Saiful; Kapur, Narinder; Orrell, Martin; Peconi, Julie; Pitts, Rosa; Poland, Fiona; Russell, Ian; Challis, David

Abstract

Background: There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approaches is sparse. The Dementia Early Stage Cognitive Aids New Trial (DESCANT) will evaluate the clinical and costeffectiveness of a range of memory aids, training and support to people with mild to moderate dementia and their carers at home and compares that intervention with treatment as usual.
Methods/design: This is a multi-site, pragmatic randomised trial preceded by a feasibility study and internal pilot. We aim to allocate at random 360 pairs comprising a person with mild to moderate dementia and an identified carer between the DESCANT intervention and treatment as usual. We assess participants at baseline, 13 and 26 weeks. The primary outcome measure is the Bristol Activities of Daily Living Scale; other participant outcomes include cognition, quality of life, activities of daily living and social networking; carer outcomes include quality of life, sense of competence and mental health. To enhance this quantitative evaluation we are conducting a qualitative component and a process evaluation to assess the implementation process and identify contextual factors associated with variation.
Discussion: The DESCANT intervention reflects current policy to enhance the capabilities of people with dementia after diagnosis and their carers. If it is clinically and cost-effective, its modest nature and cost will enhance the likelihood of it being incorporated into mainstream practice.
Trial registration: Current Controlled Trials, ISRCTN12591717. Registered on 29 July 2016.
Protocol number: 31288: North West - Haydock Research Ethics Committee, 20/06/2016, ref.: 16/NW/0389.

Citation

Chester, H., Clarkson, P., Davies, L., Hughes, J., Islam, M. S., Kapur, N., Orrell, M., Peconi, J., Pitts, R., Poland, F., Russell, I., & Challis, D. (2018). Cognitive aids for people with early stage dementia versus treatment as usual (Dementia Early Stage Cognitive Aids New Trial (DESCANT)): study protocol for a randomised controlled trial. Trials, 19(1), Article 546. https://doi.org/10.1186/s13063-018-2933-8

• Journal Article Type: Article
• Acceptance Date: Sep 24, 2018
• Online Publication Date: Oct 10, 2018
• Publication Date: Dec 30, 2018
• Deposit Date: Oct 16, 2018
• Publicly Available Date: Oct 16, 2018
• Journal: Trials
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 1
• Article Number: 546
• DOI: https://doi.org/10.1186/s13063-018-2933-8
• Keywords: Early-stage dementia, Memory aids, Community, Psychosocial outcomes, Quality of life, Effectiveness, Cost-effectiveness, Pragmatic randomised trial, Process evaluation
• Public URL: https://nottingham-repository.worktribe.com/output/1169470
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2933-8
• Contract Date: Oct 16, 2018