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The Toolkit was developed based on theory-based behaviour change and self-management techniques in consultation with people living with Parkinson\u2019s and health and social care practitioners. There are digital (e-Toolkit) and paper (manual) versions.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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\u2019s will be assessed at baseline, 6 and 12\u00a0months. Assessors will be blind to the treatment group. The primary outcome measure is the Parkinson\u2019s Disease Questionnaire (PDQ-39, Parkinson\u2019s related quality of life) score at 12\u00a0months. Secondary outcome measures include the MDS Unified Parkinson\u2019s Disease Rating Scale (Part I, II, III, IV), EQ-5D, and a Client Service Receipt Inventory shortened, adapted for Parkinson\u2019s. Carer outcomes include the Zarit Carer Burden Inventory and Carer Quality of Life Questionnaire for Parkinsonism. A total of 338 people with Parkinson\u2019s, 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>If successful, the Live Well with Parkinson\u2019s 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\u2019s audit data), by enabling patients and carers to access personalised information, advice and support on symptom management and \u2018living well\u2019 with Parkinson\u2019s.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ISRCTN92831552.\u00a0Registered on 26th Oct 2021.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-023-07700-7","type":"journal-article","created":{"date-parts":[[2023,12,5]],"date-time":"2023-12-05T15:01:50Z","timestamp":1701788510000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical and cost-effectiveness of \u2018Live Well with Parkinson\u2019s\u2019 self-management intervention versus treatment as usual for improving quality of life for people with Parkinson\u2019s: study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2173-2430","authenticated-orcid":false,"given":"Kate","family":"Walters","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Armstrong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Gardner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gareth","family":"Ambler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachael","family":"Hunter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bev","family":"Maydon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Davies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Atkinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Brown","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tasmin","family":"Rookes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Davis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette","family":"Schrag","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,12,5]]},"reference":[{"issue":"11 Suppl 5","key":"7700_CR1","first-page":"S21","volume":"54","author":"Md De Rijk","year":"2000","unstructured":"De Rijk Md, Launer L, Berger K, Breteler M, Dartigues J, Baldereschi M, et al. 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