ParkinsonismPRIME-RCTNCT05127057
Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care (PRIME-RCT)
A study testing PRIME Parkinson Care in people with Parkinsonism, run by University of Bristol at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinsonism
- What is being tested?
- PRIME Parkinson Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2022to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Population Health Sciences, University of Bristol
Bristol, BS8 2PS
About this study
Official title: Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care
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.
Read the 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.
- Conditions
- Parkinsonism
- Being tested
- PRIME Parkinson Care, Usual Care
- Keywords
- Lewy body dementia, Idiopathic Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal degeneration, Vascular dementia
- Medical subject headings
- Parkinsonian Disorders, Lewy Body Disease, Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Corticobasal Degeneration, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME Parkinson CareOther
A novel model of care
Usual CareOther
Usual NHS Care
| Study group | Role | What they receive |
|---|---|---|
| PRIME Parkinson Care | Experimental | 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. Receives: Other: PRIME Parkinson Care; Other: Usual Care |
| Usual care | Placebo comparator | Usual care provided by NHS Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal attainment
Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome
Measured: 24 months
Secondary outcomes (33)
Parkinson's disease assessment
Measured using MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Score range 0-199, higher score = worse outcome
Measured: 24 months
Non-motor symptom burden
Measured using MDS-Non-motor rating scale (MDS-NMS); Score range 0-334, higher score = worse outcome
Measured: 24 months
Parkinson's-related quality of life
Measured using The Parkinson's Disease Questionnaire (PDQ-39); Score range 0-100, higher score = worse outcome
Measured: 24 months
Fear of falling
Measured using the Iconographical Falls Efficacy Scale (ICON-FES); Score range 10-40, higher score = worse outcome
Measured: 24 months
Global Impression of change
Measured using the Patients' Global Impression of Change (PGIC);Score range 0-7, higher score = worse outcome
Measured: 24 months
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. 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
Measured: 24 months
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
Measured: 24 months
Malnutrition risk
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.
Measured: 24 months
Physical performance
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).
Measured: 24 months
Physical activity
Measured using the Incidental and Planned Exercise Questionnaire - WA Version (IPEQ-WA); Score range 0-182, higher score = better outcome
Measured: 24 months
Gait
Measured using single and dual task gait assessments
Measured: 24 months
Grip strength
Measured using hand-held dynamometer; scoring is in kg not a scale
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Hospice utilisation outside place of death
Captured from hospital and GP records
Measured: 24 months
Use of anticipatory medication
Captured from hospital and GP records
Measured: 24 months
Healthcare contacts with hospice and/or palliative care services
Captured from hospital and GP records
Measured: 24 months
Loneliness/social isolation
Measured using UCLA-Loneliness Scale (3-item); Score range 3-9, higher score = worse outcome
Measured: 24 months
Social participation
Measured using the English Longitudinal Study of Ageing questionnaire (ELSA) - scoring not a scale
Measured: 24 months
Perceived social support
Measured using Multidimensional scale of perceived social support (MSPSS); Score range 12-84, higher score = better outcome
Measured: 24 months
Coping strategy
Measured using the Brief Coping Orientation to Problems Experienced Inventory (BRIEFCope); Score range 28-112, higher score = better outcome
Measured: 24 months
Acceptance of illness
Measured using Acceptance of Illness Scale; Score range 8-40, higher score = better outcome
Measured: 24 months
Capability
Measured using the ICEpop Capability measure for older people (ICECAP-O); Score range 5-20, higher score = better outcome
Measured: 24 months
Patient Activation
Measured using Patient Activation Measure (PAM); Score range 0-100, higher score = better outcome
Measured: 24 months
Health related quality of life
Measured using EuroQol 5D-5L (EQ-5D-5L); Score range 5-25, higher score = worse outcome
Measured: 24 months
Mortality
Captured from hospital and GP records
Measured: 24 months
Healthcare events
Captured from hospital and GP records
Measured: 24 months
Frequency of Parkinson's follow-up
Captured from hospital and GP records
Measured: 24 months
Frequency and type of engagement with PRIME Parkinson care
Captured from study information
Measured: 24 months
Experience of holistic patient-centred care
Measured using Patient Assessment of Chronic Illness Care (PACIC-26); Score range 26-130, higher score = better outcome
Measured: 24 months
Montreal Cognitive Assessment
Measured using Montreal Cognitive Assessment
Measured: 24 months
Bone health
Measured using a combination of QFracture and FRAX questionnaires
Measured: 24 months
Life space assessment
Measured using LSA questionnaire collecting participant's movements over the last month
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start28 Oct 2022
- Primary completion3 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Emily J Henderson, PhD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127057
- Sponsor's protocol ID
- 2020-7271
- Acronym
- PRIME-RCT
- Status last verified
- Sep 2025
- First submitted
- 19 Oct 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39894518
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care
- ClinicalTrials.gov ID
- NCT05127057
- Acronym / sponsor ID
- PRIME-RCT / 2020-7271
- Conditions
- Parkinsonism
- Keywords
- Lewy body dementia, Idiopathic Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal degeneration, Vascular dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIME Parkinson Care | Experimental | Other: PRIME Parkinson Care, Other: Usual CarePRIME 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 | Placebo comparator | Other: Usual CareUsual care provided by NHS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIME Parkinson CareA novel model of care | Other | PRIME Parkinson Care |
| Usual CareUsual NHS Care | Other | PRIME Parkinson Care, Usual care |
Primary outcome
Goal attainment
Time frame: 24 months
Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome
33 secondary outcomes
Parkinson's disease assessment
Time frame: 24 months
Non-motor symptom burden
Time frame: 24 months
Parkinson's-related quality of life
Time frame: 24 months
Fear of falling
Time frame: 24 months
Global Impression of change
Time frame: 24 months
Frailty
Time frame: 24 months
Sarcopenia
Time frame: 24 months
Malnutrition risk
Time frame: 24 months
Physical performance
Time frame: 24 months
Physical activity
Time frame: 24 months
Gait
Time frame: 24 months
Grip strength
Time frame: 24 months
Advance Care Plan data
Time frame: 24 months
Palliative symptom burden
Time frame: 24 months
Hospice utilisation outside place of death
Time frame: 24 months
Use of anticipatory medication
Time frame: 24 months
Healthcare contacts with hospice and/or palliative care services
Time frame: 24 months
Loneliness/social isolation
Time frame: 24 months
Social participation
Time frame: 24 months
Perceived social support
Time frame: 24 months
Coping strategy
Time frame: 24 months
Acceptance of illness
Time frame: 24 months
Capability
Time frame: 24 months
Patient Activation
Time frame: 24 months
Health related quality of life
Time frame: 24 months
Mortality
Time frame: 24 months
Healthcare events
Time frame: 24 months
Frequency of Parkinson's follow-up
Time frame: 24 months
Frequency and type of engagement with PRIME Parkinson care
Time frame: 24 months
Experience of holistic patient-centred care
Time frame: 24 months
Montreal Cognitive Assessment
Time frame: 24 months
Bone health
Time frame: 24 months
Life space assessment
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 39894518Lloyd 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.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinsonism
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J Henderson, PhD principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME Parkinson Care in people with Parkinsonism, run by University of Bristol at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal attainment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.