Introduction of a Management Toolkit for Lewy Body Dementia: A Pilot Cluster‐Randomized Trial

O'Brien, John T., McKeith, Ian G., Thomas, Alan J., Bamford, Claire, Vale, Luke, Hill, Sarah, Allan, Louise, Finch, Tracy, McNally, Richard, Hayes, Louise, Surendranathan, Ajenthan, Kane, Joseph P.M., Dunn, Sarah, Bentley, Allison, Barker, Sally, Mason, James, Burn, David and Taylor, John‐Paul (2021) Introduction of a Management Toolkit for Lewy Body Dementia: A Pilot Cluster‐Randomized Trial. Movement Disorders, 36 (1). pp. 143-151. ISSN 0885-3185

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Official URL: https://doi.org/10.1002/mds.28282

Abstract

BACKGROUND: Lewy body dementia, comprising both dementia with Lewy bodies and Parkinson's disease dementia, is challenging to manage because of a complex symptom profile and lack of clear evidence-based management guidelines.

OBJECTIVES: We assessed the feasibility of undertaking a cluster randomized study of the introduction of an evidence-based management toolkit for Lewy body dementia, assessing the outcomes for patients and carers as secondary measures.

METHODS: We randomized 23 memory/dementia, movement disorder, or nonspecialist secondary care services to the management toolkit or usual care. People with dementia with Lewy bodies or Parkinson's disease dementia underwent assessments of cognition, motor and neuropsychiatric symptoms, and global outcome at baseline and 3 and 6 months. Healthcare, personal and social care costs, and carer-related outcomes of carer stress, depression, and anxiety were also examined.

RESULTS: A total of 131 participants were recruited (target 120), for whom 6-month data were available on 108 (83%). There was a benefit of being in the intervention arm for carers (reduced Zarit Burden Scale [P < 0.01], reduced depressive symptoms [P < 0.05]), who also reported less marked patient deterioration on the global outcome measure (P < 0.05). There were no significant differences in other outcomes or in costs between groups.

CONCLUSIONS: The introduction of an evidence-based management toolkit for Lewy body dementia was feasible and associated with some benefits, especially for carers. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC. on behalf of International Parkinson and Movement Disorder Society.

Item Type: Article
Additional Information: Funding Information: We thank staff of the National Institute for Health Research Clinical Research Network North East and Cumbria and East Anglia for their invaluable support with blinded participant assessment for this study. J.O.B. is supported by the National Institute for Health Research Cambridge Biomedical Research Centre Dementia and Neurodegeneration theme and the Cambridge Centre for Parkinson's Plus. J.P.T., A.T., I.G.M., and D.B. are supported by the National Institute for Health Research Newcastle Biomedical Research Centre Dementia and Neurodegeneration theme. This study was approved by the UK West Midlands–Coventry and Warwickshire Research Ethics Committee (reference: 16/WM/0025). The study was registered as ISRCTN number 11083027. Written informed consent was obtained for all participants with capacity, for those without capacity consultee written assent was obtained. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. Funding Information: John O'Brien reports grants from National Institute for Health Research (NIHR), during the conduct of the study, consultancy for TauRx, Axon, GE Healthcare, Eisai, and Roche and grant support from Alliance Medical and Merck. Ian McKeith reports grants from NIHR and consultancy for Eisai, GE Healthcare, Sanofi, and Sumitomo Dainippon Pharma. Alan Thomas reports grants from NIHR and from GE Healthcare. Luke Vale and Sarah Hill report grants from NIHR. Richard McNally reports grants from NIHR and membership of NIHR commissioned panel, 2015 to 2019. John‐Paul Taylor reports grants from NIHR. All other authors have nothing to disclose.
Uncontrolled Keywords: Lewy body dementia; clinical trial; manage-ment; dementia with Lewy bodies; Parkinson’s diseasedementia
Subjects: A100 Pre-clinical Medicine
A300 Clinical Medicine
A900 Others in Medicine and Dentistry
B900 Others in Subjects allied to Medicine
Department: Faculties > Health and Life Sciences > Nursing, Midwifery and Health
Depositing User: Rachel Branson
Date Deposited: 27 Oct 2020 15:12
Last Modified: 31 May 2021 14:43
URI: http://nrl.northumbria.ac.uk/id/eprint/44608

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