Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN.

Autor:	Greene L; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK l.m.g.greene@exeter.ac.uk., Barber R; Centre for Health of the Elderly, Cumbria Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK., Bingham A; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Connors J; 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., Conroy S; St Pancras Rehabilitation Unit, Central and North West London NHS Foundation Trust, London, UK., Elkhafer K; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Fox C; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Goodwin V; Department of Public Health and Sport Science, University of Exeter Medical School, University of Exeter, Exeter, UK., Gordon A; Academic Unit of Injury, Recovery and Inflammation Sciences (IRIS) School of Medicine, University of Nottingham, Nottingham, UK., Hall AJ; Department of Public Health and Sports Science, University of Exeter Medical School, University of Exeter, Exeter, UK., Harwood RH; School of Health Sciences, University of Nottingham School of Health Sciences, Nottingham, UK., Hulme C; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Jackson T; Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK., Litherland R; Innovations in Dementia, Exeter, UK., Morgan-Trimmer S; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Pankiewicz S; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Parry SW; Population and Health Sciences Institute Newcastle University, Newcastle University, Newcastle upon Tyne, UK., Sharma A; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Ukoumunne O; 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., Whale B; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Allan L; Department of Health and Community Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Feb 01; Vol. 14 (2), pp. e083494. Date of Electronic Publication: 2024 Feb 01.
DOI:	10.1136/bmjopen-2023-083494
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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