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NCT05127057: PRIME-RCT

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

Completed NA Last updated 29 September 2025
What this trial tests

NA trial testing PRIME Parkinson Care in Parkinsonism in 214 participants. Completed in 12 June 2025.

Timeline
28 October 2022
Primary endpoint
3 June 2025
12 June 2025

Quick facts

Lead sponsorUniversity of Bristol
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment214
Start date28 October 2022
Primary completion3 June 2025
Estimated completion12 June 2025
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Bristol

Who can join

18 and older, any sex, with Parkinsonism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for preventing falls in Parkinson's disease.
    Allen NE, Canning CG, Almeida LRS, Bloem BR, et al · · 2022 · cited 50× · PMID 35665915 · DOI 10.1002/14651858.cd011574.pub2
  2. 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.
    Lloyd K, Tenison E, Smith S, Lithander F, et al · · 2025 · PMID 39894518 · DOI 10.1136/bmjopen-2024-086353
  3. Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity.
    Tenison E, Lloyd K, Ben-Shlomo Y, Henderson EJ. · · 2025 · PMID 39759567 · DOI 10.1016/j.conctc.2024.101411
  4. 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
    Lloyd K, Tenison E, Smith S, Lithander F, et al · · 2024 · DOI 10.1101/2024.12.23.24319541

Verify or expand the search:

Other recruiting trials for Parkinsonism

Currently open trials in the same condition.

Other University of Bristol trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing