Status:
RECRUITING
Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 specializ...
Detailed Description
Parkinson's disease (PD) and related disorders are the second most common cause of motor disability in the elderly after stroke. Progressively, the disability impacts the activities of daily living an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05433441
Start Date
December 6 2022
End Date
June 6 2027
Last Update
July 23 2025
Active Locations (4)
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1
Hopital Pellegrin
Bordeaux, France, 33000
2
CHU de Lille
Lille, France, 59037
3
CHU de Limoges
Limoges, France, 87042
4
CHU Poitiers
Poitiers, France, 90577