Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): a New Model of Care (PRIME-RCT)
- Conditions
- Parkinsonism
- Interventions
- Other: PRIME Parkinson CareOther: Usual Care
- Registration Number
- NCT05127057
- Lead Sponsor
- University of Bristol
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 214
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRIME Parkinson Care 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. PRIME Parkinson Care Usual 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. Usual care Usual Care Usual care provided by NHS
- Primary Outcome Measures
Name Time Method Goal attainment 24 months Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome
- Secondary Outcome Measures
Name Time Method Parkinson's disease assessment 24 months Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome
Non-motor symptom burden 24 months Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome
Parkinson's-related quality of life 24 months Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome
Fear of falling 24 months Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome
Global Impression of change 24 months Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome
Frailty 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
Sarcopenia 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
Malnutrition risk 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.
Physical performance 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).
Physical activity 24 months Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome
Gait 24 months Measured using single and dual task gait assessments
Grip strength 24 months Measured using hand-held dynamometer; scoring is in kg not a scale
Advance Care Plan data 24 months Measured using the Edmonton Symptom Assessment System - Revised: Parkinson's disease (ESAS-R-PD); Score range 0-100, higher score = worse outcome
Palliative symptom burden 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
Hospice utilisation outside place of death 24 months Captured from hospital and GP records
Use of anticipatory medication 24 months Captured from hospital and GP records
Healthcare contacts with hospice and/or palliative care services 24 months Captured from hospital and GP records
Loneliness/social isolation 24 months Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome
Social participation 24 months Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale
Perceived social support 24 months Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome
Coping strategy 24 months Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome
Acceptance of illness 24 months Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome
Capability 24 months Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome
Patient Activation 24 months Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome
Health related quality of life 24 months Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome
Mortality 24 months Captured from hospital and GP records
Healthcare events 24 months Captured from hospital and GP records
Frequency of Parkinson's follow-up 24 months Captured from hospital and GP records
Frequency and type of engagement with PRIME Parkinson care 24 months Captured from study information
Experience of holistic patient-centred care 24 months Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome
Montreal Cognitive Assessment 24 months Measured using Montreal Cognitive Assessment
Bone health 24 months Measured using a combination of QFracture and FRAX questionnaires
Life space assessment 24 months Measured using LSA questionnaire collecting participant's movements over the last month
Trial Locations
- Locations (1)
Population Health Sciences, University of Bristol
🇬🇧Bristol, United Kingdom