Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT05127057
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care (PRIME-RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}, {'id': 'D000088282', 'term': 'Corticobasal Degeneration'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goal attainment', 'timeFrame': '24 months', 'description': 'Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome'}], 'secondaryOutcomes': [{'measure': "Parkinson's disease assessment", 'timeFrame': '24 months', 'description': "Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome"}, {'measure': 'Non-motor symptom burden', 'timeFrame': '24 months', 'description': 'Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome'}, {'measure': "Parkinson's-related quality of life", 'timeFrame': '24 months', 'description': "Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome"}, {'measure': 'Fear of falling', 'timeFrame': '24 months', 'description': 'Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome'}, {'measure': 'Global Impression of change', 'timeFrame': '24 months', 'description': "Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome"}, {'measure': 'Frailty', 'timeFrame': '24 months', 'description': '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'}, {'measure': 'Sarcopenia', 'timeFrame': '24 months', 'description': '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'}, {'measure': 'Malnutrition risk', 'timeFrame': '24 months', 'description': '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.'}, {'measure': 'Physical performance', 'timeFrame': '24 months', 'description': '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).'}, {'measure': 'Physical activity', 'timeFrame': '24 months', 'description': 'Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome'}, {'measure': 'Gait', 'timeFrame': '24 months', 'description': 'Measured using single and dual task gait assessments'}, {'measure': 'Grip strength', 'timeFrame': '24 months', 'description': 'Measured using hand-held dynamometer; scoring is in kg not a scale'}, {'measure': 'Advance Care Plan data', 'timeFrame': '24 months', 'description': "Measured using the Edmonton Symptom Assessment System - Revised: Parkinson's disease (ESAS-R-PD); Score range 0-100, higher score = worse outcome"}, {'measure': 'Palliative symptom burden', 'timeFrame': '24 months', 'description': "Measured using the Palliative Case Outcome Scale - symptom list: Parkinson's disease (POS-S-PD); Score range 0-40, higher score = worse outcome"}, {'measure': 'Hospice utilisation outside place of death', 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': 'Use of anticipatory medication', 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': 'Healthcare contacts with hospice and/or palliative care services', 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': 'Loneliness/social isolation', 'timeFrame': '24 months', 'description': 'Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome'}, {'measure': 'Social participation', 'timeFrame': '24 months', 'description': 'Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale'}, {'measure': 'Perceived social support', 'timeFrame': '24 months', 'description': 'Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome'}, {'measure': 'Coping strategy', 'timeFrame': '24 months', 'description': 'Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome'}, {'measure': 'Acceptance of illness', 'timeFrame': '24 months', 'description': 'Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome'}, {'measure': 'Capability', 'timeFrame': '24 months', 'description': 'Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome'}, {'measure': 'Patient Activation', 'timeFrame': '24 months', 'description': 'Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome'}, {'measure': 'Health related quality of life', 'timeFrame': '24 months', 'description': 'Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome'}, {'measure': 'Mortality', 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': 'Healthcare events', 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': "Frequency of Parkinson's follow-up", 'timeFrame': '24 months', 'description': 'Captured from hospital and GP records'}, {'measure': 'Frequency and type of engagement with PRIME Parkinson care', 'timeFrame': '24 months', 'description': 'Captured from study information'}, {'measure': 'Experience of holistic patient-centred care', 'timeFrame': '24 months', 'description': 'Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': '24 months', 'description': 'Measured using Montreal Cognitive Assessment'}, {'measure': 'Bone health', 'timeFrame': '24 months', 'description': 'Measured using a combination of QFracture and FRAX questionnaires'}, {'measure': 'Life space assessment', 'timeFrame': '24 months', 'description': "Measured using LSA questionnaire collecting participant's movements over the last month"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lewy body dementia', "Idiopathic Parkinson's Disease", 'Multiple System Atrophy', 'Progressive Supranuclear Palsy', 'Corticobasal degeneration', 'Vascular dementia'], 'conditions': ['Parkinsonism']}, 'referencesModule': {'references': [{'pmid': '39894518', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nCurrent care models are often inadequate to meet their needs.\n\nThis 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.", 'detailedDescription': "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.\n\nMethods: 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.\n\nDiscussion: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have a diagnosis of parkinsonism made by a movement disorder specialist\n2. Be willing to participate\n3. 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\n4. Age 18 years and above.\n5. Resident within the geographical catchment area of Royal United Hospital Bath NHS Foundation Trust, UK\n\nExclusion Criteria:\n\n1. Patients with drug, infection or toxin induced parkinsonism\n2. 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\n3. 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."}, 'identificationModule': {'nctId': 'NCT05127057', 'acronym': 'PRIME-RCT', 'briefTitle': "Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care (PRIME-RCT)", 'organization': {'class': 'OTHER', 'fullName': 'University of Bristol'}, 'officialTitle': "Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care", 'orgStudyIdInfo': {'id': '2020-7271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRIME Parkinson Care', 'description': '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.', 'interventionNames': ['Other: PRIME Parkinson Care', 'Other: Usual Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care provided by NHS', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'PRIME Parkinson Care', 'type': 'OTHER', 'description': 'A novel model of care', 'armGroupLabels': ['PRIME Parkinson Care']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual NHS Care', 'armGroupLabels': ['PRIME Parkinson Care', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS8 2PS', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Population Health Sciences, University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'Emily J Henderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bristol'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bristol', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}