NCT05127057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

October 19, 2021

Last Update Submit

September 23, 2025

Conditions

Parkinsonism

Keywords

Lewy body dementiaIdiopathic Parkinson's DiseaseMultiple System AtrophyProgressive Supranuclear PalsyCorticobasal degenerationVascular dementia

Outcome Measures

Primary Outcomes (1)

  • Goal attainment

    Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome

    24 months

Secondary Outcomes (33)

  • Parkinson's disease assessment

    24 months

  • Non-motor symptom burden

    24 months

  • Parkinson's-related quality of life

    24 months

  • Fear of falling

    24 months

  • Global Impression of change

    24 months

  • +28 more secondary outcomes

Study Arms (2)

PRIME Parkinson Care

EXPERIMENTAL

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 CareOther: Usual Care

Usual care

PLACEBO COMPARATOR

Usual care provided by NHS

Other: Usual Care

Interventions

PRIME Parkinson CareOTHER

A novel model of care

PRIME Parkinson Care
Usual CareOTHER

Usual NHS Care

PRIME Parkinson CareUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of parkinsonism made by a movement disorder specialist
  • Be willing to participate
  • 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
  • Age 18 years and above.
  • Resident within the geographical catchment area of Royal United Hospital Bath NHS Foundation Trust, UK

You may not qualify if:

  • Patients with drug, infection or toxin induced parkinsonism
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Health Sciences, University of Bristol

Bristol, BS8 2PS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 39894518DERIVED

MeSH Terms

Conditions

Parkinsonian DisordersLewy Body DiseaseParkinson DiseaseMultiple System AtrophySupranuclear Palsy, ProgressiveCorticobasal DegenerationDementia, Vascular

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersDementiaSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emily J Henderson, PhD

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 19, 2021

Study Start

October 28, 2022

Primary Completion

June 3, 2025

Study Completion

June 12, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

GB(1)