PRIME Model of Care in Parkinson's - A Randomised Controlled Trial
Research type
Research Study
Full title
Proactive and Integrated Management and Empowerment in Parkinson’s Disease (PRIME): Designing a New Model of Care – A Randomised Controlled Trial
IRAS ID
283416
Contact name
Emily Henderson
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
We aim to evaluate a new model of care termed ‘PRIME Parkinson Care’ (Proactive and Integrated Management and Empowerment in Parkinson’s) for people living with Parkinson’s, and their caregivers. Patients will be randomly allocated to either PRIME Parkinson Care, or will continue with their usual care through the NHS and other services.
Those in the PRIME Parkinson Care (intervention) arm will receive additional support from the PRIME team to achieve their treatment goals. Care will be personalised to their particular needs and priorities: e.g. exercise, healthy eating, sleep or medication. Usual care from their Parkinson’s team will continue, but they will also be able to access PRIME Care in addition. PRIME Parkinson Care encompasses their respective caregivers who will also receive additional support through the study including invitations to workshops and peer support groups.
Both patients and caregivers in the usual care arm will receive exactly the same care as they would if they were not in the trial. ‘Usual care’ will be provided through the NHS and other services, and participants will continue to be followed up in the usual way by their Parkinson’s consultant and nurse specialist. Written information signposting ways of accessing help through their usual team will be provided.
Participants in both arms will be asked to complete questionnaires and speak to the study team every 3 months over the 2-year period. They will be asked to attend the hospital for an assessment visit at the start of the trial and again after 1 year and then the final visit is after 2 years. They will be sent questionnaires to complete before they attend each visit. These visits may take place in their home if appropriate. Likewise, caregivers will be asked to complete questionnaires, and attend these three hospital visits.
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0387
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion