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NCT Number: NCT07578272

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, 31300, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient questionnaires

Other

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

Caregiver questionnaires

Other

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

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.

    Time frame: 6 months after the inclusion

    Percentage of patients who adhere to the program, i.e., who accept the partial or complete program according to their needs

Secondary outcomes

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

    Time frame: 6 months after the inclusion

    Responses to the quality of life questionnaire at baseline and 6 months post-inclusion

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

    Time frame: 6 months after the inclusion

    Caregiver responses to the quality of life questionnaire at baseline and 6 months post-inclusion

  3. Evaluation of satisfaction with the flexible and local care pathway

    Time frame: 6 months after the inclusion

    Responses to the satisfaction questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Fabienne ORY MAGNE, MD

CONTACT

[email protected]

0561775687 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PRIMS-PARK

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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