A development study and randomised feasibility trial of a tailored intervention to improve activity and reduce falls in older adults with mild cognitive impairment and mild dementia

Harwood, Rowan H. and van der Wardt, Veronika and Goldberg, Sarah E. and Keamey, Fiona and Logan, Pip and Hood-Moore, Victoria and Booth, Victoria and Hancox, Jennie E. and Masud, Tahir and Hoare, Zoe and Brand, Andrew and Tudor Edwards, Rhiannon and Jones, Carys and das Nair, Roshan and Pollock, Kristian and Godfrey, Maureen and Gladman, John R.F. and Vedhara, Kavita and Smith, Helen and Orrell, Martin (2018) A development study and randomised feasibility trial of a tailored intervention to improve activity and reduce falls in older adults with mild cognitive impairment and mild dementia. Pilot and Feasibility Studies, 4 . 49/1-49/12. ISSN 2055-5784

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Abstract

Background:

People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses.

Methods:

We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis.

Discussion:

In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial.

Trial registration:

ClinicalTrials.gov: NCT02874300; ISRCTN 10550694.

Item Type: Article
Keywords: Dementia; Activities of daily living; Therapeutic exercise; Occupational therapy; Physiotherapy; Falls; Randomised controlled trial; Adherence; Economic evaluation; Process evaluation
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Psychiatry and Applied Psychology
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Primary Care
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Rehabilitation and Ageing
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Health Sciences
Identification Number: https://doi.org/10.1186/s40814-018-0239-y
Related URLs:
URLURL Type
https://creativecommons.org/licenses/by/4.0/UNSPECIFIED
Depositing User: McCambridge, Mrs April
Date Deposited: 20 Feb 2018 09:14
Last Modified: 02 Jul 2018 09:18
URI: http://eprints.nottingham.ac.uk/id/eprint/49866

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