Parkinson DiseasePRIMS-PARKNCT07578272
Prevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study
A study testing Patient questionnaires and Caregiver questionnaires in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Patient questionnaires and Caregiver questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Neurologie Cognitive, Comportementale et Mouvement anormaux CHU de Toulouse, Hôpital Pierre Paul Riquet, 31059 Toulouse Cedex 9
Toulouse, 31300
About this 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.
- Conditions
- Parkinson Disease
- Being tested
- Patient questionnaires, Caregiver questionnaires
- Keywords
- care pathway, parkinson, caregiver
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient questionnairesOther
Patients will need to complete questionnaires to establish and evaluate their care pathway.
Caregiver questionnairesOther
Caregivers will need to complete questionnaires in order to establish and evaluate the care plan.
| Study group | Role | What they receive |
|---|---|---|
| patients benefiting from a care pathway | Experimental | patients benefiting from a flexible and local care pathway Receives: Other: Patient questionnaires |
| caregivers of Parkinson's disease patients | Other | Not described Receives: Other: Caregiver questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Responses to the quality of life questionnaire at baseline and 6 months post-inclusion
Measured: 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
Measured: 6 months after the inclusion
Evaluation of satisfaction with the flexible and local care pathway
Responses to the satisfaction questionnaire
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578272
- Sponsor's protocol ID
- RC31/25/0025
- Other IDs
- ID-RCB
- Acronym
- PRIMS-PARK
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT07578272
- Acronym / sponsor ID
- PRIMS-PARK / RC31/25/0025
- Conditions
- Parkinson Disease
- Keywords
- care pathway, parkinson, caregiver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 May 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients benefiting from a care pathway | Experimental | Other: Patient questionnairespatients benefiting from a flexible and local care pathway |
| caregivers of Parkinson's disease patients | Other | Other: Caregiver questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Patient questionnairesPatients will need to complete questionnaires to establish and evaluate their care pathway. | Other | patients benefiting from a care pathway |
| Caregiver questionnairesCaregivers will need to complete questionnaires in order to establish and evaluate the care plan. | Other | caregivers of Parkinson's disease patients |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient questionnaires and Caregiver questionnaires in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 May 2026. 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 France. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabienne ORY MAGNE, MD (0561775687 ext. +33, ory.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.