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Not yet recruiting NCT07578272

Prevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient questionnaires, Caregiver questionnaires.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Patient questionnaires
    Patients will need to complete questionnaires to establish and evaluate their care pathway.
  • Other Caregiver questionnaires
    Caregivers will need to complete questionnaires in order to establish and evaluate the care plan.

Primary outcome measures

  • Evaluate, in newly diagnosed Parkinson's patients, adherence to a new, flexible, and local care pathway after the announcement of the Parkinson's disease. [Time frame: 6 months after the inclusion]
Secondary outcome measures (3)
  • Evaluation of the flexible and local care pathway based on the patient's medical and psychological parameters. [Time frame: 6 months after the inclusion]
  • Evaluation of the flexible and local care pathway on the well-being of caregivers [Time frame: 6 months after the inclusion]
  • Evaluation of satisfaction with the flexible and local care pathway [Time frame: 6 months after the inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Double blind
Primary purpose
Prevention

Study locations

France · 1 center
  • Service de Neurologie Cognitive, Comportementale et Mouvement anormaux CHU de Toulouse, Hô — Toulouse

Identifiers

NCT: NCT07578272 · RC31/25/0025 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗