NCT05405998

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 disease at the stage of motor complications. This care pathway corresponds to a care program combining therapeutic education of the patient, modification of the hospital course and city-hospital coordination. The content of this program is detailed below in chapter III.3. Experimental group: proactive care pathway. The interest of the protocol will be evaluated at several levels: from the patients' point of view, from the caregivers' point of view, from the medico-economic point of view. Among all the indicators, the achievement of autonomy is retained as the main criterion (see chapter on main evaluation criterion). Secondary objectives are to measure the value of the proactive care pathway on: * Patient-related parameters Psychobehavioral factors (quality of life, self-esteem, mood...) ; Treatment persistence; Patient satisfaction; Clinical symptomatology (overall clinical impression, motor and non-motor symptoms, impulse control disorders). * Caregiver burden. * Use of the care system in both groups and medico-economic impact of the intervention (cost-consequence analysis and cost-utility analysis) from a societal perspective; For this study, patients will be accompanied by their caregivers.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-01-01
• Completion: 2025-07-01
• First posted: 2022-06-06
• Last updated: 2023-06-09

Locations

1 site across 1 country: France