Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN
Victoria Goodwin,
Rowan H Harwood,
Chris Fox,
Obioha Ukoumunne,
Simon Conroy,
Claire Hulme,
Adam Gordon,
T Jackson,
Abigail J Hall,
Sarah Morgan-Trimmer,
Louise Allan,
Steve W Parry,
James Connors,
Robert Barber,
Bethany Whale,
Leanne Greene,
Rachael Litherland,
Alison Bingham,
Kamr Elkhafer,
Sophie Pankiewicz,
Ashima Sharma
Affiliations
Victoria Goodwin
Department of Public Health and Sport Science, University of Exeter Medical School, University of Exeter, Exeter, UK
Rowan H Harwood
professor of palliative and end of life care
Chris Fox
3 University of Exeter, Exeter, UK
Obioha Ukoumunne
NIHR Applied Research Collaboration South West Peninsula, Department of Health and Community Sciences, Faculty of Health and Life Sciences University of Exeter, University of Exeter, Exeter, UK
Simon Conroy
MRC Unit for Lifelong Health and Ageing, University College London, London, UK
Claire Hulme
4 Health Economics Group, University of Exeter, Exeter, UK
Adam Gordon
4 NIHR Applied Research Collaboration-East Midlands (ARC-EM), Leicester, UK
T Jackson
Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK
Abigail J Hall
Department of Public Health and Sports Science, University of Exeter Medical School, University of Exeter, Exeter, UK
Sarah Morgan-Trimmer
3 Department of Health and Community Sciences, University of Exeter Faculty of Health and Life Sciences, Exeter, UK
Louise Allan
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Steve W Parry
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
James Connors
NIHR Applied Research Collaboration South West Peninsula, Department of Health and Community Sciences, Faculty of Health and Life Sciences University of Exeter, University of Exeter, Exeter, UK
Robert Barber
Centre for Health of the Elderly, Cumbria Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK
Bethany Whale
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Leanne Greene
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Rachael Litherland
Innovations in Dementia, Exeter, UK
Alison Bingham
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Kamr Elkhafer
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Sophie Pankiewicz
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Ashima Sharma
Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
Introduction Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.Method and analysis This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.Ethics and dissemination The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.Trial registration number ISRCTN16413728.
