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Completed

NCT Number: NCT05127057

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

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.

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Key information

Conditions

Parkinsonism Arterial Occlusive Diseases Arteriosclerosis Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Corticobasal Degeneration Cranial Nerve Diseases Dementia Dementia, Vascular Eye Diseases Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Movement Disorders Multiple System Atrophy Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Population Health Sciences, University of Bristol

Bristol, BS8 2PS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

PRIME Parkinson Care

Other

A novel model of care

Usual Care

Other

Usual NHS Care

Primary outcomes

  1. Goal attainment

    Time frame: 24 months

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

Secondary outcomes

  1. Parkinson's disease assessment

    Time frame: 24 months

    Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome

  2. Non-motor symptom burden

    Time frame: 24 months

    Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome

  3. Parkinson's-related quality of life

    Time frame: 24 months

    Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome

  4. Fear of falling

    Time frame: 24 months

    Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome

  5. Global Impression of change

    Time frame: 24 months

    Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome

  6. Frailty

    Time frame: 24 months

    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

  7. Sarcopenia

    Time frame: 24 months

    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

  8. Malnutrition risk

    Time frame: 24 months

    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.

  9. Physical performance

    Time frame: 24 months

    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).

  10. Physical activity

    Time frame: 24 months

    Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome

  11. Gait

    Time frame: 24 months

    Measured using single and dual task gait assessments

  12. Grip strength

    Time frame: 24 months

    Measured using hand-held dynamometer; scoring is in kg not a scale

  13. Advance Care Plan data

    Time frame: 24 months

    Measured using the Edmonton Symptom Assessment System - Revised: Parkinson's disease (ESAS-R-PD); Score range 0-100, higher score = worse outcome

  14. Palliative symptom burden

    Time frame: 24 months

    Measured using the Palliative Case Outcome Scale - symptom list: Parkinson's disease (POS-S-PD); Score range 0-40, higher score = worse outcome

  15. Hospice utilisation outside place of death

    Time frame: 24 months

    Captured from hospital and GP records

  16. Use of anticipatory medication

    Time frame: 24 months

    Captured from hospital and GP records

  17. Healthcare contacts with hospice and/or palliative care services

    Time frame: 24 months

    Captured from hospital and GP records

  18. Loneliness/social isolation

    Time frame: 24 months

    Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome

  19. Social participation

    Time frame: 24 months

    Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale

  20. Perceived social support

    Time frame: 24 months

    Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome

  21. Coping strategy

    Time frame: 24 months

    Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome

  22. Acceptance of illness

    Time frame: 24 months

    Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome

  23. Capability

    Time frame: 24 months

    Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome

  24. Patient Activation

    Time frame: 24 months

    Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome

  25. Health related quality of life

    Time frame: 24 months

    Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome

  26. Mortality

    Time frame: 24 months

    Captured from hospital and GP records

  27. Healthcare events

    Time frame: 24 months

    Captured from hospital and GP records

  28. Frequency of Parkinson's follow-up

    Time frame: 24 months

    Captured from hospital and GP records

  29. Frequency and type of engagement with PRIME Parkinson care

    Time frame: 24 months

    Captured from study information

  30. Experience of holistic patient-centred care

    Time frame: 24 months

    Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome

  31. Montreal Cognitive Assessment

    Time frame: 24 months

    Measured using Montreal Cognitive Assessment

  32. Bone health

    Time frame: 24 months

    Measured using a combination of QFracture and FRAX questionnaires

  33. Life space assessment

    Time frame: 24 months

    Measured using LSA questionnaire collecting participant's movements over the last month

Sponsors and collaborators

Lead sponsor

University of Bristol

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

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

Acronym: PRIME-RCT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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