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

Parkinsonism Clinical Trial

— PRIME-RCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05127057
• Other study ID #: 2020-7271
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Other:
• PRIME Parkinson Care
A novel model of care
• Usual Care
Usual NHS Care

Locations

Country	Name	City	State
United Kingdom	Population Health Sciences, University of Bristol	Bristol

Sponsors (2)

Lead Sponsor	Collaborator
University of Bristol	Radboud University Medical Center

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal attainment	Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome	24 months
Secondary	Parkinson's disease assessment	Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome	24 months
Secondary	Non-motor symptom burden	Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome	24 months
Secondary	Parkinson's-related quality of life	Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome	24 months
Secondary	Fear of falling	Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome	24 months
Secondary	Global Impression of change	Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome	24 months
Secondary	Frailty	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	24 months
Secondary	Frailty	Measured using Pictorial fit frail scale; Score range 0-43, higher score = worse outcome	24 months
Secondary	Frailty	Measured using clinical frailty scale; Score range 0-9, higher score = worse outcome	24 months
Secondary	Sarcopenia	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	24 months
Secondary	Sarcopenia	Measured using the Sluggishness, Assistance in walking, rising from a chair, climb stairs, falls, calf circumference questionnaire (SARC-CalF); Score range 0-20, higher score = worse outcome	24 months
Secondary	Malnutrition risk	Measured using the Malnutrition Universal Screening Tool (MUST); Score range 0-6, higher score = worse outcome	24 months
Secondary	Malnutrition risk	Measured using the Seniors in the community: risk evaluation for eating and nutrition (SCREEN-II-14); Score range 0-64, higher score = better outcome	24 months
Secondary	Physical performance	Measured using the Short Physical Performance Battery (SPPB); Score range 0-12, higher score = better outcome	24 months
Secondary	Physical performance	Measured using the Timed up and Go (TUG); score is not a scale (timing)	24 months
Secondary	Physical activity	Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome	24 months
Secondary	Gait	Measured using single and dual task gait assessments	24 months
Secondary	Grip strength	Measured using hand-held dynamometer; scoring is in kg not a scale	24 months
Secondary	Advance Care Plan data	Measured using the Edmonton Symptom Assessment System - Revised: Parkinson's disease (ESAS-R-PD); Score range 0-100, higher score = worse outcome	24 months
Secondary	Palliative symptom burden	Measured using the Palliative Case Outcome Scale - symptom list: Parkinson's disease (POS-S-PD); Score range 0-40, higher score = worse outcome	24 months
Secondary	Hospice utilisation outside place of death	Captured from hospital and GP records	24 months
Secondary	Use of anticipatory medication	Captured from hospital and GP records	24 months
Secondary	Healthcare contacts with hospice and/or palliative care services	Captured from hospital and GP records	24 months
Secondary	Loneliness/social isolation	Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome	24 months
Secondary	Social participation	Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale	24 months
Secondary	Perceived social support	Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome	24 months
Secondary	Coping strategy	Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome	24 months
Secondary	Acceptance of illness	Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome	24 months
Secondary	Capability	Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome	24 months
Secondary	Patient Activation	Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome	24 months
Secondary	Health related quality of life	Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome	24 months
Secondary	Mortality	Captured from hospital and GP records	24 months
Secondary	Healthcare events	Captured from hospital and GP records	24 months
Secondary	Frequency of Parkinson's follow-up	Captured from hospital and GP records	24 months
Secondary	Frequency and type of engagement with PRIME Parkinson care	Captured from study information	24 months
Secondary	Experience of holistic patient-centred care	Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome	24 months
Secondary	Montreal Cognitive Assessment	Measured using Montreal Cognitive Assessment	24 months
Secondary	Bone health	Measured using a combination of QFracture and FRAX questionnaires	24 months
Secondary	Life space assessment	Measured using LSA questionnaire collecting participant's movements over the last month	24 months