TY - JOUR
T1 - 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
AU - Lithander, Fiona E.
AU - Tenison, Emma
AU - Ypinga, Jan
AU - Halteren, Angelika
AU - Smith, Matthew D.
AU - Lloyd, Katherine
AU - Richfield, Edward W.
AU - Brazier, Danielle E.
AU - Breasail, Mícheál
AU - Smink, Agnes J.
AU - Metcalfe, Chris
AU - Hollingworth, William
AU - Bloem, Bas
AU - Munneke, Marten
AU - Ben-Shlomo, Yoav
AU - Darweesh, Sirwan K.L.
AU - Henderson, Emily J.
N1 - Funding Information:
EJH received funding from the National Institute of Health Technology (NIHR), the Gatsby Foundation and Parkinson’s UK; received fees for speaking and consultancy from Profile pharma Medicys and Luye and received travel support from Bial Abbvie and Ever pharma.
Funding Information:
YBS is a recipient of a Radboud Excellence award. He has received research support from the UK Medical Research Council, Wellcome Trust, NIHR, Parkinson’s UK, Versus Arthritis, Gatsby Foundation, Dunhill Trust.
Funding Information:
The trial is supported by a grant from the Gatsby Foundation. This research is part of the collaborative Proactive and Integrated Management and Empowerment in Parkinson’s Disease (PRIME Parkinson) project, which is a healthcare innovation project in selected areas of the UK and the Netherlands. The PRIME Parkinson project is financed by the Gatsby Foundation and co-funded by the PPP Allowance made available by Health Holland, Top Sector Life Sciences & Health, to stimulate public-private partnerships.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/2/27
Y1 - 2023/2/27
N2 - Background: People 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. Methods: This 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. Discussion: This 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.
AB - Background: People 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. Methods: This 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. Discussion: This 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.
KW - Clinical trial
KW - Complex intervention
KW - Informed consent
KW - Parkinson disease, Parkinsonian disorders
KW - Parkinsonism
KW - Randomised controlled trial
KW - Research design
UR - http://www.scopus.com/inward/record.url?scp=85148976560&partnerID=8YFLogxK
U2 - 10.1186/s13063-023-07084-8
DO - 10.1186/s13063-023-07084-8
M3 - Article
C2 - 36849987
AN - SCOPUS:85148976560
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 147
ER -