Clinical trial NCT05127057: Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): a New Model of Care (PRIME-RCT)
Official title: Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): a New Model of Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinsonism
Keywords: Lewy body dementia
Idiopathic Parkinson's Disease
Multiple System Atrophy
Progressive Supranuclear Palsy
Corticobasal degeneration
Vascular dementia
Lead sponsor: University of Bristol
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2021-11-19
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of parkinsonism made by a movement disorder specialist
2. Be willing to participate
3. 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
4. Age 18 years and above.
5. Resident within the geographical catchment area of Royal United Hospital Bath NHS Foundation Trust, UK

Exclusion Criteria:

1. Patients with drug, infection or toxin induced parkinsonism
2. 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
3. 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.

Primary outcomes:
measure: Goal attainment
timeFrame: 24 months
Secondary outcomes:
measure: Parkinson's disease assessment
timeFrame: 24 months
measure: Non-motor symptom burden
timeFrame: 24 months
measure: Parkinson's-related quality of life
timeFrame: 24 months
measure: Fear of falling
timeFrame: 24 months
measure: Global Impression of change
timeFrame: 24 months
measure: Frailty
timeFrame: 24 months
measure: Sarcopenia
timeFrame: 24 months
measure: Malnutrition risk
timeFrame: 24 months
measure: Physical performance
timeFrame: 24 months
measure: Physical activity
timeFrame: 24 months
measure: Gait
timeFrame: 24 months
measure: Grip strength
timeFrame: 24 months
measure: Advance Care Plan data
timeFrame: 24 months
measure: Palliative symptom burden
timeFrame: 24 months
measure: Hospice utilisation outside place of death
timeFrame: 24 months
measure: Use of anticipatory medication
timeFrame: 24 months
measure: Healthcare contacts with hospice and/or palliative care services
timeFrame: 24 months
measure: Loneliness/social isolation
timeFrame: 24 months
measure: Social participation
timeFrame: 24 months
measure: Perceived social support
timeFrame: 24 months
measure: Coping strategy
timeFrame: 24 months
measure: Acceptance of illness
timeFrame: 24 months
measure: Capability
timeFrame: 24 months
measure: Patient Activation
timeFrame: 24 months
measure: Health related quality of life
timeFrame: 24 months
measure: Mortality
timeFrame: 24 months
measure: Healthcare events
timeFrame: 24 months
measure: Frequency of Parkinson's follow-up
timeFrame: 24 months
measure: Frequency and type of engagement with PRIME Parkinson care
timeFrame: 24 months
measure: Experience of holistic patient-centred care
timeFrame: 24 months
measure: Montreal Cognitive Assessment
timeFrame: 24 months
measure: Bone health
timeFrame: 24 months
measure: Life space assessment
timeFrame: 24 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Population Health Sciences, University of Bristol
Study officials:
affiliation: University of Bristol
name: Emily J Henderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: