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  • R Bajwa
  • S. Goldberg
  • Veronika van der Wardt
    University of Nottingham
  • C Burgon
  • C di Lorito
  • Maureen Godfrey
    University of Nottingham
  • M. R. Dunlop
  • Pip Logan
    University of Nottingham
  • Tahir Masud
    Nottingham University Hospitals NHS Trust
  • John Gladman
    University of Nottingham
  • Helen Smith
    Nottingham University Hospitals NHS Trust
  • Vicky Hood-Moore
    University of Nottingham
  • Vicky Booth
    University of Nottingham
  • Roshan das Nair
    University of Nottingham
  • K. Pollock
  • Kavita Vedhara
    University of Nottingham
  • Rhiannon Tudor Edwards
  • Carys Jones
  • Zoe Hoare
  • Andrew Brand
  • Rowan Harwood
    Nottingham University Hospitals NHS Trust

BACKGROUND: People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness.

METHODS: We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective.

DISCUSSION: We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia.

TRIAL REGISTRATION: ISRCTN, ISRCTN15320670. Registered on 4 September 2018.

Original languageEnglish
Article number815
Number of pages11
Issue number1
Publication statusPublished - 30 Dec 2019

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