NCT05433441 Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
| NCT ID | NCT05433441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-12-06 |
| Primary Completion | 2025-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2022-12-06 with a primary completion date of 2025-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease
Eligibility Criteria
Inclusion Criteria: For the patient: * Patient with a diagnosis of idiopathic Parkinson's disease * Patient over 18 years ; * Patient with a Hoehn and Yahr Stage greater than or equal to 3; * Patient without major cognitive impairment defined by a MOCA score ≥21 * Patient living at home ; * Patient with an identified non-professional primary caregiver; * Person affiliated with or benefiting from a social security plan; * Free, informed and and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research). For the caregiver: * Male or female over 18 years * Able to respond to research interviews/questionnaires * Free, informed and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research). Exclusion Criteria: For the patient: * Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state; * Institutionalized or foster care patients; * Patients with a known severe and unstable general pathology that does not allow for patient follow-up; * Patients already included in another non-drug management trial; * Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments; * Patients under guardianship or unable to express consent * Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up; * Presence of a primary caregiver with a known severe and unstable disease that does not allow for the conduct of the study; * Presence of a primary caregiver with a known cognitive or psychiatric disorder (chronic progressive psychosis) that does not allow for the proper conduct of the study. * Pregnant or breastfeeding woman. For the caregiver: * Unable to follow the research interviews or questionnaires. * Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up; * Primary caregiver with a known severe and unstable illness that does not allow for the proper conduct of the study; * Primary caregiver with known cognitive or psychiatric disorders (chronic progressive psychosis) that do not allow the study to be conducted properly.
Contact & Investigator
Alexandra FOUBERT-SAMIER
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05433441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05433441 currently recruiting?
Yes, NCT05433441 is actively recruiting participants. Contact the research team at alexandra.samier-foubert@u-bordeaux.fr for enrollment information.
Where is the NCT05433441 trial being conducted?
This trial is being conducted at Bordeaux, France, Lille, France, Limoges, France, Poitiers, France.
Who is sponsoring the NCT05433441 clinical trial?
NCT05433441 is sponsored by University Hospital, Bordeaux. The principal investigator is Alexandra FOUBERT-SAMIER at University Hospital, Bordeaux. The trial plans to enroll 250 participants.
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