Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care (PRIME-RCT) (PRIME-RCT)

Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care

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.

Study Overview

• Status: Completed
• Conditions: Parkinsonism
• Intervention / Treatment: Other: PRIME Parkinson Care; Other: Usual Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS8 2PS
    • Population Health Sciences, University of Bristol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have a diagnosis of parkinsonism made by a movement disorder specialist
2. Be willing to participate
3. Have the ability to provide informed consent to participant, or where unable to do so due to cognitive impairment, availability of a close friend or relative to act as a personal consultee
4. Age 18 years and above.
5. Resident within the geographical catchment area of Royal United Hospital Bath NHS Foundation Trust, UK

Exclusion Criteria:

1. Patients with drug, infection or toxin induced parkinsonism
2. Patients who lack capacity to participate but do not have anyone who can be a consultee to provide advice regarding the patient's wishes and views
3. Patients with a current medical, cognitive or psychosocial issue or co-enrolment in other study that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRIME Parkinson Care; 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; A novel model of care; Other: Usual Care; Usual NHS Care
Placebo Comparator: Usual care; Usual care provided by NHS	Other: Usual Care; Usual NHS Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal attainment	Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parkinson's disease assessment	Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome	24 months
Non-motor symptom burden	Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome	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	24 months
Fear of falling	Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome	24 months
Global Impression of change	Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome	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	24 months
Physical activity	Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome	24 months
Gait	Measured using single and dual task gait assessments	24 months
Grip strength	Measured using hand-held dynamometer; scoring is in kg not a scale	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	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	24 months
Hospice utilisation outside place of death	Captured from hospital and GP records	24 months
Use of anticipatory medication	Captured from hospital and GP records	24 months
Healthcare contacts with hospice and/or palliative care services	Captured from hospital and GP records	24 months
Loneliness/social isolation	Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome	24 months
Social participation	Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale	24 months
Perceived social support	Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome	24 months
Coping strategy	Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome	24 months
Acceptance of illness	Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome	24 months
Capability	Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome	24 months
Patient Activation	Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome	24 months
Health related quality of life	Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome	24 months
Mortality	Captured from hospital and GP records	24 months
Healthcare events	Captured from hospital and GP records	24 months
Frequency of Parkinson's follow-up	Captured from hospital and GP records	24 months
Frequency and type of engagement with PRIME Parkinson care	Captured from study information	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	24 months
Montreal Cognitive Assessment	Measured using Montreal Cognitive Assessment	24 months
Bone health	Measured using a combination of QFracture and FRAX questionnaires	24 months
Life space assessment	Measured using LSA questionnaire collecting participant's movements over the last month	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	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.	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).	24 months

Collaborators and Investigators

• Sponsor: University of Bristol
• Collaborators: Radboud University Medical Center
• Investigators: Principal Investigator: Emily J Henderson, PhD, University of Bristol

Publications and helpful links

General Publications

• Lloyd K, Tenison E, Smith S, Lithander F, Kidger J, Brant H, Redwood S, Ben-Shlomo Y, Henderson EJ. Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial. BMJ Open. 2025 Feb 2;15(1):e086353. doi: 10.1136/bmjopen-2024-086353.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): June 3, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Progressive Supranuclear Palsy; Multiple System Atrophy; Vascular dementia; Lewy body dementia; Idiopathic Parkinson's Disease; Corticobasal degeneration
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Eye Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Cranial Nerve Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Leukoencephalopathies; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Ophthalmoplegia; Ocular Motility Disorders; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Corticobasal Degeneration; Parkinson Disease; Multiple System Atrophy; Dementia, Vascular; Supranuclear Palsy, Progressive; Lewy Body Disease; Parkinsonian Disorders
• Other Study ID Numbers: 2020-7271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No