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

NCT ID: NCT05127057

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2025-06-12

Brief Summary

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.

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.

Conditions

Parkinsonism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PRIME Parkinson Care

Intervention Type: OTHER

A novel model of care

Usual Care

Intervention Type: OTHER

Usual NHS Care

Usual care

Usual care provided by NHS

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual NHS Care

Interventions

PRIME Parkinson Care

A novel model of care

Intervention Type: OTHER

Usual Care

Usual NHS Care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

University of Bristol

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily J Henderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bristol

Locations

Population Health Sciences, University of Bristol

Bristol, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39894518 (View on PubMed)

Other Identifiers

2020-7271

Identifier Type: -

Identifier Source: org_study_id