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Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy (AUTAP)

NCT05405998 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-06-09

No results posted yet for this study

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 initiation of this therapy, most of the patients need nurse services at home for the entire duration of treatment. Some patients are reluctant about this dependence and thus may refuse or delay the initiation of CSAI. To date, there is no guideline to promote patients' autonomy in managing CSAI treatment. Thus we developed a program focusing on early autonomy during CSAI intitiation, through empowering the patient or their carer, and promoting primary and tertiary care.

The hypothesis is that implementing the program will lead patients to autonomy. This will have beneficial effects on clinical and heath-related outcomes and may be cost-effective.

Conditions

  • Parkinson Disease

Interventions

OTHER

Proactive care pathway

Patient participation in a specific therapeutic education program, as soon as the therapeutic decision is made. The reinforced cooperation of the expert centers with the homecare providers on 2 different times: 1. before the installation of the pump, i.e. before the episode of hospitalization dedicated to the starting of the treatment; 2. after the installation of the pump following the above mentioned hospitalization.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · Assistance Publique - Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-01-31
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405998 on ClinicalTrials.gov