Prevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study (PRIMS-PARK)

Parkinson's disease (PD) is the second most common neurodegenerative disease worldwide, with a prevalence expected to double by 2040. The diagnosis of PD is often a shock for patients and their families, due to a lack of preparation and adequate support. Progress has been made with the establishment of Parkinson's disease expert centers (PDECs) and better-structured care pathways, but limitations remain. The needs of patients, their caregivers, and neurologists at the time of diagnosis were studied, leading to the development of a flexible, adaptable, and multidisciplinary home-based care pathway. This pathway includes multimodal communication tools (booklet and website) and can also be used by caregivers. The aim is to evaluate this pathway at the departmental level and its ability to prevent the medical, social, and psychosocial risks that complicate the care of patients newly diagnosed with PD. Thus, offering the patient, their caregiver and their neurologist a truly flexible and local care pathway built according to their needs, from the moment the disease is announced, could allow for better acceptance of the disease, an improvement in quality of life, the adoption of beneficial practices as well as a patient-caregiver therapeutic alliance with good adherence to drug and non-drug therapies.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Patient questionnaires; Other: Caregiver questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabienne ORY MAGNE, MD; Phone Number: +33 0561775687; Email: ory.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31300
    • Service de Neurologie Cognitive, Comportementale et Mouvement anormaux CHU de Toulouse, Hôpital Pierre Paul Riquet, 31059 Toulouse Cedex 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For patients:

• Patients with newly diagnosed Parkinson's disease (< 1 month)
• Over 18 years of age

For caregivers (if the caregiver does not wish to participate, the patient can be included):

• Primary caregiver of a patient with newly diagnosed Parkinson's disease (< 1 month)
• Over 18 years of age

Exclusion Criteria:

For patients

• Institutionalized patients
• Residents of an area not covered by the intervention zone of specialized neurodegenerative disease teams

For caregivers

- Participants who do not wish to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients benefiting from a care pathway; patients benefiting from a flexible and local care pathway	Other: Patient questionnaires; Patients will need to complete questionnaires to establish and evaluate their care pathway.
Other: caregivers of Parkinson's disease patients	Other: Caregiver questionnaires; Caregivers will need to complete questionnaires in order to establish and evaluate the care plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate, in newly diagnosed Parkinson's patients, adherence to a new, flexible, and local care pathway after the announcement of the Parkinson's disease.	Percentage of patients who adhere to the program, i.e., who accept the partial or complete program according to their needs	6 months after the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the flexible and local care pathway based on the patient's medical and psychological parameters.	Responses to the quality of life questionnaire at baseline and 6 months post-inclusion	6 months after the inclusion
Evaluation of the flexible and local care pathway on the well-being of caregivers	Caregiver responses to the quality of life questionnaire at baseline and 6 months post-inclusion	6 months after the inclusion
Evaluation of satisfaction with the flexible and local care pathway	Responses to the satisfaction questionnaire	6 months after the inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: care pathway; caregiver; parkinson
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: RC31/25/0025; ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No