Proactive and Integrated Management and Empowerment in Parkinson’s Disease protocol for a randomised controlled trial (PRIME-UK) to evaluate a new model of care

Trials

Study Protocol

Chris Metcalfe¹  Marten Munneke²  Sirwan K. L. Darweesh²  Jan Ypinga²  Angelika Halteren²  Agnes J. Smink²  Bas Bloem²  Edward W. Richfield³  Yoav Ben-Shlomo⁴  Mícheál Ó. Breasail⁴  Danielle E. Brazier⁴  Matthew D. Smith⁴  Katherine Lloyd⁴  Emma Tenison⁴  William Hollingworth⁵  Fiona E. Lithander⁶  Emily J. Henderson⁷ 

[1]Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, BS8 2PS, Bristol, UK

[2]Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[3]North Bristol NHS Trust, Southmead Hospital, Westbury-on-Trym, BS10 5NB, Bristol, UK

[4]Population Health Sciences, Bristol Medical School, University of Bristol, BS8 1NU, Bristol, UK

[5]Population Health Sciences, Bristol Medical School, University of Bristol, BS8 1NU, Bristol, UK

[6]Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, BS8 2PS, Bristol, UK

[7]Population Health Sciences, Bristol Medical School, University of Bristol, BS8 1NU, Bristol, UK

[8]Liggins Institute, University of Auckland, 1142, Auckland, New Zealand

[9]Department of Nutrition and Dietetics, University of Auckland, 1142, Auckland, New Zealand

[10]Population Health Sciences, Bristol Medical School, University of Bristol, BS8 1NU, Bristol, UK

[11]Royal United Hospitals Bath NHS Foundation Trust, Combe Park, BA1 3NG, Bath, UK

关键词: Parkinson disease, Parkinsonian disorders;    Parkinsonism;    Randomised controlled trial;    Complex intervention;    Research design;    Clinical trial;    Informed consent;   

DOI  :  10.1186/s13063-023-07084-8

 received in 2021-10-21, accepted in 2022-12-20,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundPeople living with Parkinson’s disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life and can lead to an increased risk of hospitalisation. It is increasingly recognised that the current care models are not suitable for the needs of people with parkinsonism whose care needs evolve and change as the disease progresses. This trial aims to evaluate whether a complex and innovative model of integrated care will increase an individual’s ability to achieve their personal goals, have a positive impact on health and symptom burden and be more cost-effective when compared with usual care.MethodsThis is a single-centre, randomised controlled trial where people with parkinsonism and their informal caregivers are randomised into one of two groups: either PRIME Parkinson multi-component model of care or usual care. Adults ≥18 years with a diagnosis of parkinsonism, able to provide informed consent or the availability of a close friend or relative to act as a personal consultee if capacity to do so is absent and living in the trial geographical area are eligible. Up to three caregivers per patient can also take part, must be ≥18 years, provide informal, unpaid care and able to give informed consent. The primary outcome measure is goal attainment, as measured using the Bangor Goal Setting Interview. The duration of enrolment is 24 months. The total recruitment target is n=214, and the main analyses will be intention to treat.DiscussionThis trial tests whether a novel model of care improves health and disease-related metrics including goal attainment and decreases hospitalisations whilst being more cost-effective than the current usual care. Subject to successful implementation of this intervention within one centre, the PRIME Parkinson model of care could then be evaluated within a cluster-randomised trial at multiple centres.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 3