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
Helen Chester,
Paul Clarkson,
Linda Davies,
Jane Hughes,
Muhammad Saiful Islam,
Narinder Kapur,
Martin Orrell,
Julie Peconi,
Rosa Pitts,
Fiona Poland,
Ian Russell,
David Challis,
Members of the HoSt-D (Home Support in Dementia) Programme Management Group
Affiliations
Helen Chester
Personal Social Services Research Unit, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Paul Clarkson
Personal Social Services Research Unit, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Linda Davies
Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Jane Hughes
Personal Social Services Research Unit, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Muhammad Saiful Islam
Swansea Trials Unit, Institute of Life Science 2, Medical School, Swansea University
Narinder Kapur
Research Department of Clinical, Educational and Health Psychology, University College London
Martin Orrell
Institute of Mental Health, School of Medicine, University of Nottingham
Julie Peconi
Swansea Trials Unit, Institute of Life Science 2, Medical School, Swansea University
Rosa Pitts
Personal Social Services Research Unit, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Fiona Poland
School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia
Ian Russell
Swansea Trials Unit, Institute of Life Science 2, Medical School, Swansea University
David Challis
Personal Social Services Research Unit, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre
Members of the HoSt-D (Home Support in Dementia) Programme Management Group
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 cost-effectiveness 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.