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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

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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.
Literature
1.
Prince M, Wimo A, Guerchet M, Ali GC, Wu YT, Prina M. Alzheimer’s Disease International. World Alzheimer Report 2015: The global impact of dementia: an analysis of prevalence, incidence, cost and trends. [Homepage]. United Kingdom: Alzheimer’s Disease International; 2015 [updated 1 October 2015; 6th March 2017]. Available from: https://​www.​alz.​co.​uk/​research/​WorldAlzheimerRe​port2015.​pdf.
2.
3.
Royal College of Psychiatrists. MSNAP third national report 2013 - 2014. London: The Royal College of Psychiatrists; 2015.
4.
5.
Department of Health. Prime Minister’s challenge on dementia 2020. London: Department of Health; 2015.
6.
Gillespie A, Best C, O’Neill B. Cognitive function and assistive technology for cognition: a systematic review. J Int Neuropsychol Soc. 2012;18:1–19.CrossRefPubMed
7.
Gillespie A, O’Neill B. Assistive technology for cognition: a handbook for clinicians and developers. Hove, East Sussex: Psychology Press; 2014.
8.
van der Roest HG, Wenborn J, Pastink C, Dröes RM, Orrell M. Assistive technology for memory support in dementia. Cochrane Database Syst Rev. 2017;6:CD009627.PubMed
9.
Lauriks S, Reinersmann A, Van der Roest HG, Meiland FJ, Davies RJ, Moelaert F, Mulvenna MD, Nugent CD, Dröes RM. Review of ICT-based services for identified unmet needs in people with dementia. Ageing Res Rev 2007;6:223–246.CrossRefPubMed
10.
McGrath M, Passmore P. Home-based memory rehabilitation programme for persons with mild dementia. Ir J Med Sci. 2009;178(Suppl 8):S2330.
11.
Topo P. Technology studies to meet the needs of people with dementia and their caregivers: a literature review. J Appl Gerontol. 2009;28:5–37.CrossRef
12.
Swansea Trials Unit. Essential documents for trial master files (TMFs), investigator site files (ISFs) and pharmacy site files (PSFs), AD031, Swansea Trials Unit, Swansea University; 2017. [not publicly available].
13.
Alzheimer’s Society. The memory handbook: a practical guide to living with memory problems. London: Alzheimer’s Society; 2014.
14.
Bucks RS, Ashworth DL, Wilcock GK, Siegfried K. Assessment of activities of daily living in dementia: development of the Bristol Activities of Daily Living Scale. Age Ageing. 1996;25:113–20.CrossRefPubMed
15.
Charlesworth G, Burnell K, Hoe J, Orrell M, Russell IT. Acceptance checklist for clinical effectiveness pilot trials (ACCEPT). BMC Med Res Methodol. 2013;13(78):1–7.
16.
House of Commons. Mental Capacity Act 2005. Chapter 9. London: House of Commons; 2005.
17.
Byrne L, Wilson P, Bucks R, Hughes A, Wilcock G. The sensitivity to change over time of the Bristol Activities of Daily Living Scale in Alzheimer’s disease. Int J Geriatr Psychiatry. 2000;15:656–61.CrossRefPubMed
18.
Molloy D, Standish T. Mental status and neuropsychological assessment: a guide to the Standardised Mini-Mental State Examination. Int Psychogeriatr. 1997;9:87–94.CrossRefPubMed
19.
Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982;140:566–72.CrossRefPubMed
20.
Coast J, Flynn TN, Natarajan L, Sproston K, Lewis J, Louviere JJ, Peters TJ. Valuing the ICECAP capability index for older people. Soc Sci Med. 2008;67:874–82.CrossRefPubMed
21.
Hyde M, Wiggins RD, Higgs P, Blane DB. A measure of quality of life in early old age: the theory, development and properties of a needs satisfaction model (CASP-19). Aging Ment Health. 2003;7:186–94.CrossRefPubMed
22.
Netuveli G, Wiggins R, Hildon Z, Montgomery S, Blane D. Quality of life at older ages: evidence from the English longitudinal study of aging (wave 1). J Epidemiol Community Health. 2006;60:357–63.CrossRefPubMedCentralPubMed
23.
Smith SC, Lamping DL, Banerjee S, Harwood R, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. Health Technol Assess. 2005;9:10.
24.
Teunisse S, Derix M, van Crevel H. Assessing the severity of dementia: patient and caregiver. Arch Neurol 1991;48:274–277.CrossRefPubMed
25.
26.
Lubben J, Gironda M. Centrality of social ties to the health and well-being of older adults. In: Berkman B, Harooytan L, editors. Social work and health care in an aging world. New York: Springer; 2003. p. 319–50.
27.
Wenger GC. A network typology: from theory to practice. J Aging Stud. 1991;5:147–62.CrossRef
28.
Wenger G, Tucker I. Using network variation in practice: identification of support network type. Health Soc Care Commun. 2002;10(1):28–35.CrossRef
29.
Vernooji-Dassen M, Felling A, Brummelkamp E, Dauzenberg M, van den Bos G, Grol R. Assessment of caregiver’s competence in dealing with the burden of caregiving for a dementia patient: a short sense of competence questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc. 1997;47:256–7.CrossRef
30.
Goldberg DP. Manual of the General Health Questionnaire. Windsor, Berkshire: NFER-Nelson; 1978.
31.
Beecham J, Knapp M. Costing psychiatric interventions. In: Thornicroft G, Brewin CR, Wing J, editors. Measuring mental health needs. London: Gaskell; 1992.
32.
Wimo A, Wetterholm AL, Mastey V, Winblad B. Evaluation of the healthcare utilisation and caregiver time in anti-dementia drug trials – a quantitative battery. In: Wimo A, Jonsson B, Karlsson G, Winblad B, editors. Health economics of dementia. Chichester: Wiley; 1998.
33.
EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.CrossRef
34.
35.
Russell D, Hoare ZSJ, Whitaker R, Whitaker CJ, Russell IT. Generalised method for adaptive randomisation in clinical trials. Stat Med. 2011;30:922–34.PubMed
36.
Lowe CM, Wilson MS, Sackley CM, Barker KL. Blind outcome assessment: the development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial. Clin Rehabil. 2011;25:264–74.CrossRef
37.
38.
Swansea Trials Unit. Dementia Early Stage Cognitive Aids- New Trial (DESCANT): MACRO4 handbook, Version 0.3. Swansea Trials Unit, Swansea University; 2017. [not publicly available].
39.
40.
Kiresuk TJ, Sherman RE. Goal Attainment Scaling: a general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968;4:443–53.CrossRefPubMed
41.
Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982;21:1–16.CrossRefPubMed
42.
McDermott O, Orrell M, Ridder HM. The development of Music in Dementia Assessment Scales (MiDAS). Nordic J Music Ther. 2015;24:3,232–51.CrossRef
43.
Lewis SJ, Russell AJ. Being embedded: a way forward for ethnographic research. Ethnography. 2011;12:398–416.CrossRef
44.
O’Reilly M, Parker N. ‘Unsatisfactory saturation’: a critical exploration of the notion of saturated sample sizes in qualitative research. Qual Res. 2013;13:190–7.CrossRef
45.
46.
47.
van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15:708–15.CrossRefPubMed
48.
Davies LM, Barnes TRE, Jones PB, Lewis S, Gaughran F, Hayhurst K, Markwick A, Lloyd H. A randomized controlled trial of the cost-utility of second-generation antipsychotics in people with psychosis and eligible for clozapine. Value Health. 2008;4:549–62.CrossRef
49.
Raftery JP. NICE’s cost-effectiveness range: should it be lowered? PharmacoEconomics. 2014;32:613–5.CrossRefPubMed
50.
Claxton K, Martin S, Soares M, Rice N, Spackman E, Hinde S, Devlin N, Smith P, Sculpher M. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19:14. https://​doi.​org/​10.​3310/​hta19140.CrossRef
51.
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10:779–87.CrossRefPubMed
52.
Guest G, Bruce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18:59–82.CrossRef
53.
Clarkson P, Giebel C, Larbey M, Roe B, Challis D, Hughes J, Jolley D, Poland F, Russell I, members of the HoSt-D (Home Support in Dementia) Programme Management Group. A protocol for a systematic review of effective home support to people with dementia and their carers: components and impacts. Journal Adv Nurs. 2016;72:186–96.CrossRef
54.
Clarkson P, Hughes J, Roe B, Giebel C, Jolley D, Poland F, Abendstern M, Chester H, Challis D, members of the HoSt-D (Home Support in Dementia) Programme Management Group. Systematic review: effective home support in dementia care, components and impacts – stage 2, effectiveness of home support interventions. J Adv Nurs. 2018;74:507–27.CrossRefPubMed
55.
56.
Hedrick SC, Koepsell TD, Inui T. Meta-analysis of home care on mortality and nursing home placement. Med Care. 1989;27:1015–26.CrossRefPubMed
57.
National Audit Office. Improving services and support for people with dementia. London: The Stationery Office; 2007.
58.
Association of Directors of Adult Social Services. Response by the Association of Directors of Adult Social Services (ADASS) to 2011 inquiry of the All-Party Parliamentary Group on Dementia: How to save money in dementia care and deliver better outcomes for people with dementia? London: ADASS; 2011.
59.
Department of Health. Living well with dementia: a national dementia strategy. London: Department of Health; 2009.
60.
Department of Health. The Government’s mandate to NHS England for 2017–18. London: Department of Health; 2017.
61.
Medical Research Council. Final report from the MAGDR Subgroup 1 on priority topics in dementia research. London: MRC; 2011.
62.
Chester H, Clarkson P, Kapur N, Challis D, Orrell M, Ainsworth C, Ledgerd R, Pimlott B, Spector A, Woods B. Using memory aids in early-stage dementia: a pragmatic randomised trial - Intervention manual. Manchester: PSSRU, University of Manchester; 2017.
Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2933-8

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