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

Leanne Greene; Robert Barber; Alison Bingham; James Connors; Simon Conroy; Kamr Elkhafer; Chris Fox; Victoria Goodwin; Adam Gordon; Abigail J Hall; Rowan H Harwood; Claire Hulme; T Jackson; Rachael Litherland; Sarah Morgan-Trimmer; Sophie Pankiewicz; Steve W Parry; Ashima Sharma; Obioha Ukoumunne; Bethany Whale; Louise Allan

doi:10.1136/bmjopen-2023-083494

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

Leanne Greene^*, Robert Barber, Alison Bingham, James Connors, Simon Conroy, Kamr Elkhafer, Chris Fox, Victoria Goodwin, Adam Gordon, Abigail J Hall, Rowan H Harwood, Claire Hulme, T Jackson, Rachael Litherland, Sarah Morgan-Trimmer, Sophie Pankiewicz, Steve W Parry, Ashima Sharma, Obioha Ukoumunne, Bethany WhaleLouise Allan

^*Corresponding author for this work

Inflammation and Ageing

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Article number	e083494
Number of pages	9
Journal	BMJ open
Volume	14
Issue number	2
DOIs	https://doi.org/10.1136/bmjopen-2023-083494
Publication status	Published - 1 Feb 2024

Bibliographical note

Funding:
This study is funded by the Alzheimer’s Society (grant number 586) and has been awarded a project grant with a grant period of 36 months. This project is supported by Exeter Biomedical Research Centre and National Institute for Health and Care Research (NIHR) Applied Research Collaboration Southwest Peninsula (PenARC). The views expressed are those of the author(s) and not necessarily those of the Alzheimer’s Society, Exeter Biomedical Research Centre or NIHR or the Department of Health and Social Care.

Keywords

Patient-Centered Care
Aging
Dementia
Clinical trials
Quality of Life

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Greene, L., Barber, R., Bingham, A., Connors, J., Conroy, S., Elkhafer, K., Fox, C., Goodwin, V., Gordon, A., Hall, A. J., Harwood, R. H., Hulme, C., Jackson, T., Litherland, R., Morgan-Trimmer, S., Pankiewicz, S., Parry, S. W., Sharma, A., Ukoumunne, O., ... Allan, L. (2024). Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN. BMJ open, 14(2), Article e083494. https://doi.org/10.1136/bmjopen-2023-083494

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abstract = "Introduction: Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual{\textquoteright}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.",

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author = "Leanne Greene and Robert Barber and Alison Bingham and James Connors and Simon Conroy and Kamr Elkhafer and Chris Fox and Victoria Goodwin and Adam Gordon and Hall, {Abigail J} and Harwood, {Rowan H} and Claire Hulme and T Jackson and Rachael Litherland and Sarah Morgan-Trimmer and Sophie Pankiewicz and Parry, {Steve W} and Ashima Sharma and Obioha Ukoumunne and Bethany Whale and Louise Allan",

note = "Funding: This study is funded by the Alzheimer{\textquoteright}s Society (grant number 586) and has been awarded a project grant with a grant period of 36 months. This project is supported by Exeter Biomedical Research Centre and National Institute for Health and Care Research (NIHR) Applied Research Collaboration Southwest Peninsula (PenARC). The views expressed are those of the author(s) and not necessarily those of the Alzheimer{\textquoteright}s Society, Exeter Biomedical Research Centre or NIHR or the Department of Health and Social Care.",

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doi = "10.1136/bmjopen-2023-083494",

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Greene, L, Barber, R, Bingham, A, Connors, J, Conroy, S, Elkhafer, K, Fox, C, Goodwin, V, Gordon, A, Hall, AJ, Harwood, RH, Hulme, C, Jackson, T, Litherland, R, Morgan-Trimmer, S, Pankiewicz, S, Parry, SW, Sharma, A, Ukoumunne, O, Whale, B & Allan, L 2024, 'Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN', BMJ open, vol. 14, no. 2, e083494. https://doi.org/10.1136/bmjopen-2023-083494

TY - JOUR

T1 - Maintaining independence in individuals with dementia at home after a fall

T2 - a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

AU - Greene, Leanne

AU - Barber, Robert

AU - Bingham, Alison

AU - Connors, James

AU - Conroy, Simon

AU - Elkhafer, Kamr

AU - Fox, Chris

AU - Goodwin, Victoria

AU - Gordon, Adam

AU - Hall, Abigail J

AU - Harwood, Rowan H

AU - Hulme, Claire

AU - Jackson, T

AU - Litherland, Rachael

AU - Morgan-Trimmer, Sarah

AU - Pankiewicz, Sophie

AU - Parry, Steve W

AU - Sharma, Ashima

AU - Ukoumunne, Obioha

AU - Whale, Bethany

AU - Allan, Louise

N1 - Funding: This study is funded by the Alzheimer’s Society (grant number 586) and has been awarded a project grant with a grant period of 36 months. This project is supported by Exeter Biomedical Research Centre and National Institute for Health and Care Research (NIHR) Applied Research Collaboration Southwest Peninsula (PenARC). The views expressed are those of the author(s) and not necessarily those of the Alzheimer’s Society, Exeter Biomedical Research Centre or NIHR or the Department of Health and Social Care.

PY - 2024/2/1

Y1 - 2024/2/1

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. 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.

AB - 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.

KW - Patient-Centered Care

KW - Aging

KW - Dementia

KW - Clinical trials

KW - Quality of Life

U2 - 10.1136/bmjopen-2023-083494

DO - 10.1136/bmjopen-2023-083494

M3 - Article

SN - 2044-6055

VL - 14

JO - BMJ open

JF - BMJ open

IS - 2

M1 - e083494

ER -

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

Abstract

Bibliographical note

Keywords

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