An interventional study of PRIME Parkinson Care and Usual Care in Parkinsonism, sponsored by University of Bristol. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by University of Bristol · Not applicable, Interventional, and Health services research
People living with Parkinson's disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life. Symptoms emerge and evolve as the disease progresses.
Current care models are often inadequate to meet their needs.
This study 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.
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 study 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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 214 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Bristol is the lead sponsor of 22 studies on the registry; none are open to participants now.
Compared within Parkinson Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Parkinsonian Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRIME Parkinson Care is a multi-component model of care comprising individual components: a) Case management b) Empowerment of patients and care givers c) Empowerment of healthcare professionals d) IT infrastructure.
Other: PRIME Parkinson Care · Other: Usual Care
Usual care provided by NHS
Other: Usual Care
A novel model of care
Usual NHS Care
Goal attainment
Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome
Time frame: 24 months
Parkinson's disease assessment
Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome
Time frame: 24 months
Non-motor symptom burden
Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome
Time frame: 24 months
Parkinson's-related quality of life
Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome
Time frame: 24 months
Fear of falling
Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome
Time frame: 24 months
Global Impression of change
Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome
Time frame: 24 months
Frailty
Measured using The Frailty Instrument of the Survey of Health, Ageing and Retirement in Europe (SHARE-FI75+); Score range 0-1, higher score = worse outcome. Measured using Measured using Pictorial fit frail scale; Score range 0-43, higher score = worse outcome. Measured using clinical frailty scale; Score range 0-9, higher score = worse outcome
Time frame: 24 months
Sarcopenia
Measured using the Sluggishness, Assistance in walking, rising from a chair, climb stairs, falls questionnaire (SARC-F); Score range 0-10, higher score = worse outcome
Time frame: 24 months
Malnutrition risk
Measured using the Malnutrition Universal Screening Tool (MUST); Score range 0-6, higher score = worse outcome. Measured using the Seniors in the community: risk evaluation for eating and nutrition (SCREEN-II-14); Score range 0-64, higher score = better outcome.
Time frame: 24 months
Physical performance
Measured using the Short Physical Performance Battery (SPPB); Score range 0-12, higher score = better outcome. Measured using the Timed up and Go (TUG); score is not a scale (timing).
Time frame: 24 months
Physical activity
Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome
Time frame: 24 months
Gait
Measured using single and dual task gait assessments
Time frame: 24 months
Grip strength
Measured using hand-held dynamometer; scoring is in kg not a scale
Time frame: 24 months
Advance Care Plan data
Measured using the Edmonton Symptom Assessment System - Revised: Parkinson's disease (ESAS-R-PD); Score range 0-100, higher score = worse outcome
Time frame: 24 months
Palliative symptom burden
Measured using the Palliative Case Outcome Scale - symptom list: Parkinson's disease (POS-S-PD); Score range 0-40, higher score = worse outcome
Time frame: 24 months
Hospice utilisation outside place of death
Captured from hospital and GP records
Time frame: 24 months
Use of anticipatory medication
Captured from hospital and GP records
Time frame: 24 months
Healthcare contacts with hospice and/or palliative care services
Captured from hospital and GP records
Time frame: 24 months
Loneliness/social isolation
Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome
Time frame: 24 months
Social participation
Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale
Time frame: 24 months
Perceived social support
Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome
Time frame: 24 months
Coping strategy
Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome
Time frame: 24 months
Acceptance of illness
Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome
Time frame: 24 months
Capability
Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome
Time frame: 24 months
Patient Activation
Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome
Time frame: 24 months
Health related quality of life
Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome
Time frame: 24 months
Mortality
Captured from hospital and GP records
Time frame: 24 months
Healthcare events
Captured from hospital and GP records
Time frame: 24 months
Frequency of Parkinson's follow-up
Captured from hospital and GP records
Time frame: 24 months
Frequency and type of engagement with PRIME Parkinson care
Captured from study information
Time frame: 24 months
Experience of holistic patient-centred care
Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome
Time frame: 24 months
Montreal Cognitive Assessment
Measured using Montreal Cognitive Assessment
Time frame: 24 months
Bone health
Measured using a combination of QFracture and FRAX questionnaires
Time frame: 24 months
Life space assessment
Measured using LSA questionnaire collecting participant's movements over the last month
Time frame: 24 months
Plan to share: Undecided
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Bristol