NCT07578272

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Parkinson Disease

Keywords

care pathwayparkinsoncaregiver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluation of the flexible and local care pathway based on the patient's medical and psychological parameters.

    6 months after the inclusion

  • Evaluation of the flexible and local care pathway on the well-being of caregivers

    6 months after the inclusion

  • Evaluation of satisfaction with the flexible and local care pathway

    6 months after the inclusion

Study Arms (2)

patients benefiting from a care pathway

EXPERIMENTAL

patients benefiting from a flexible and local care pathway

Other: Patient questionnaires

caregivers of Parkinson's disease patients

OTHER
Other: Caregiver questionnaires

Interventions

Patient questionnairesOTHER

Patients will need to complete questionnaires to establish and evaluate their care pathway.

patients benefiting from a care pathway
Caregiver questionnairesOTHER

Caregivers will need to complete questionnaires in order to establish and evaluate the care plan.

caregivers of Parkinson's disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Fabienne ORY MAGNE, MD

CONTACT

0561775687ory.f@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 11, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)