Walters, Kate; Armstrong, Megan; Gardner, Ben; Ambler, Gareth; Hunter, Rachael; Maydon, Bev; Davies, Nathan; ... Schrag, Anette; + view all Walters, Kate; Armstrong, Megan; Gardner, Ben; Ambler, Gareth; Hunter, Rachael; Maydon, Bev; Davies, Nathan; Atkinson, Catherine; Brown, Richard; Rookes, Tasmin; Davis, Daniel; Schrag, Anette; - view fewer (2023) Clinical and cost-effectiveness of ‘Live Well with Parkinson’s’ self-management intervention versus treatment as usual for improving quality of life for people with Parkinson’s: study protocol for a randomised controlled trial. Trials , 24 , Article 793. 10.1186/s13063-023-07700-7.

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Abstract

Background: The Live Well with Parkinson’s Self-Management Toolkit is designed for use in the NHS to support people with Parkinson’s, their carers and health professionals in managing motor and non-motor symptoms and promoting well-being. The Toolkit was developed based on theory-based behaviour change and self-management techniques in consultation with people living with Parkinson’s and health and social care practitioners. There are digital (e-Toolkit) and paper (manual) versions.// Methods: Single-blind two-arm randomised controlled trial RCT of clinical effectiveness and cost-effectiveness of the Toolkit, facilitated by up to six sessions with a trained non-specialist supporter, in improving quality of life. People with Parkinson’s will be assessed at baseline, 6 and 12 months. Assessors will be blind to the treatment group. The primary outcome measure is the Parkinson’s Disease Questionnaire (PDQ-39, Parkinson’s related quality of life) score at 12 months. Secondary outcome measures include the MDS Unified Parkinson’s Disease Rating Scale (Part I, II, III, IV), EQ-5D, and a Client Service Receipt Inventory shortened, adapted for Parkinson’s. Carer outcomes include the Zarit Carer Burden Inventory and Carer Quality of Life Questionnaire for Parkinsonism. A total of 338 people with Parkinson’s, and their carers if appropriate, will be recruited from diverse settings across England. Those with advanced dementia, at end-of-life or with atypical Parkinsonism will be excluded. A parallel mixed methods process evaluation will explore the factors promoting or inhibiting implementation, uptake, use, effectiveness and cost-effectiveness of the Toolkit and sessions.// Discussion: If successful, the Live Well with Parkinson’s Toolkit could be used as a model for other complex long-term disorders, including dementia. This would bridge existing gaps in the NHS (as shown by the national Parkinson’s audit data), by enabling patients and carers to access personalised information, advice and support on symptom management and ‘living well’ with Parkinson’s.// Trial registration: ISRCTN92831552. Registered on 26th Oct 2021.

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