TY  - JOUR
PY  - 2024//
TI  - Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN
JO  - BMJ open
A1  - Greene, Leanne
A1  - Barber, Robert
A1  - Bingham, Alison
A1  - Connors, James
A1  - Conroy, Simon
A1  - Elkhafer, Kamr
A1  - Fox, Chris
A1  - Goodwin, Victoria
A1  - Gordon, Adam
A1  - Hall, Abigail J.
A1  - Harwood, Rowan H.
A1  - Hulme, Claire
A1  - Jackson, T.
A1  - Litherland, Rachael
A1  - Morgan-Trimmer, Sarah
A1  - Pankiewicz, Sophie
A1  - Parry, Steve W.
A1  - Sharma, Ashima
A1  - Ukoumunne, Obioha
A1  - Whale, Bethany
A1  - Allan, Louise
SP  - e083494
EP  - e083494
VL  - 14
IS  - 2
N2  - 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. <br><br>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.<p />  <p>Language: en</p>
LA  - en
SN  - 2044-6055
UR  - http://dx.doi.org/10.1136/bmjopen-2023-083494
ID  - ref1
ER  -