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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.; van der Wardt, Veronika; Goldberg, Sarah E.; Keamey, Fiona; Logan, Pip; Hood-Moore, Victoria; Booth, Victoria; Hancox, Jennie E.; Masud, Tahir; Hoare, Zoe; Brand, Andrew; Tudor Edwards, Rhiannon; Jones, Carys; das Nair, Roshan; Pollock, Kristian; Godfrey, Maureen; Gladman, John R.F.; Vedhara, Kavita; Smith, Helen; Orrell, Martin

Authors

Fiona Keamey

PIP LOGAN pip.logan@nottingham.ac.uk
Professor of Rehabilitation Research

Tahir Masud tahir.masud@nuh.nhs.uk

Zoe Hoare

Andrew Brand

Rhiannon Tudor Edwards

Carys Jones

ROSHAN NAIR Roshan.dasnair@nottingham.ac.uk
Professor of Clinical Psychology and Neuropsychology

Maureen Godfrey

JOHN GLADMAN john.gladman@nottingham.ac.uk
Professor of Medicine of Older People

KAVITA VEDHARA kavita.vedhara@nottingham.ac.uk
Professor in Applied Psychology

Helen Smith

MARTIN ORRELL M.ORRELL@NOTTINGHAM.AC.UK
Director - Institute of Mental Health_*d



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.

Citation

Harwood, R. H., van der Wardt, V., Goldberg, S. E., Keamey, F., Logan, P., Hood-Moore, V., …Orrell, M. (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, https://doi.org/10.1186/s40814-018-0239-y

Journal Article Type Article
Acceptance Date Jan 24, 2018
Publication Date Feb 17, 2018
Deposit Date Feb 20, 2018
Publicly Available Date Feb 20, 2018
Journal Pilot and Feasibility Studies
Electronic ISSN 2055-5784
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 4
Article Number 49
DOI https://doi.org/10.1186/s40814-018-0239-y
Keywords Dementia; Activities of daily living; Therapeutic exercise; Occupational therapy; Physiotherapy; Falls; Randomised controlled trial; Adherence; Economic evaluation; Process evaluation
Public URL http://eprints.nottingham.ac.uk/id/eprint/49866
Publisher URL https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0239-y
Related Public URLs https://creativecommons.org/licenses/by/4.0/
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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