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

NCT ID: NCT05405998

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-07-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group : proactive course

The strategy is based on the implementation of an "optimized" proactive care pathway, combining elements that promote city-hospital coordination in setting up the pump and elements that promote patient education.

Group Type: EXPERIMENTAL

Proactive care pathway

Intervention Type: OTHER

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.

Control group : optimized medical treatment

At the end of the inclusion visit (see previous chapter), the patient will be invited to come to the hospital two weeks later for pump placement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Marseille

Locations

AP-HM

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume HACHE

Role: CONTACT

guillaume.hache@ap-hm.fr

(0)4 91 38 43 98

Claire MORANDO

Role: CONTACT

claire.morando@ap-hm.fr

0(4) 91 38 21 83

Facility Contacts

Guillaume HACHE

Role: primary

Other Identifiers

2021-A01424-37

Identifier Type: -

Identifier Source: org_study_id