Status:
UNKNOWN
Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy (AUTAP)
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Continuous subcutaneous apomorphine infusion (CSAI) has proven to be effective in advaced Parkinson's disease patients with motor fluctuations not controlled by oral or transdermal medication. After i...
Detailed Description
The main objective of the project is to evaluate the impact of the proactive care pathway during the installation of an apomorphine pump on the autonomy at 6 months of patients with Parkinson's diseas...
Eligibility Criteria
Inclusion
- Patient of legal age;
- Affiliated to the social security;
- Parkinson's disease according to the diagnostic criteria of the UK Parkinson's disease society brain bank clinical diagnostic criteria;
- Presence of disabling motor fluctuations and/or dyskinesia despite optimized oral treatment (MDS-UPDRS IV item \>2)
- Patient eligible for and accepting apomorphine pump therapy
- Autonomous patient (Hoehn and Yahr stage \< 4);
- No significant cognitive impairment (MoCA \>= 25)
- Patient can be autonomous on the daily management of the pump according to the investigator's opinion.
- Patient having signed an informed consent
Exclusion
- Significant cognitive impairment (MoCA score \<25);
- Major depressive episode, uncontrolled at the time of assessment (BDI\>25) or bipolar disorder;
- Active visual hallucinations or history of severe hallucination episodes;
- Previous apomorphine pump use;
- History of respiratory distress;
- History of severe impulse control disorders;
- Patient and/or caregiver who cannot be empowered in the opinion of the investigator.
- Protected persons, curators, persons under court protection, persons deprived of liberty by judicial or administrative decision, persons under forced psychiatric care and persons admitted to a health or social institution for purposes other than those of the research
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05405998
Start Date
December 1 2022
End Date
July 1 2025
Last Update
June 9 2023
Active Locations (1)
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1
AP-HM
Marseille, France