Clinical trial NCT05405998: Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy (AUTAP)
Official title: Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluation of autonomy
timeFrame: 6 months
measure: Unified Parkinson's disease rating scale (MDS-UPDRS), section VI (Schwab and England)
timeFrame: 6 months
Secondary outcomes:
measure: Parkinson disease questionnaire 39 (PDQ39)
timeFrame: 6 months and 12 months
measure: MDS-UPDRS section II
timeFrame: 6 months and 12 months
measure: MDS-UPDRS section I
timeFrame: 6 months and 12 months
measure: Clinical Global impression
timeFrame: 6 months and 12 months
measure: MDS-UPDRS III and IV
timeFrame: 6 months and 12 months
measure: QUIP RS
timeFrame: 6 months and 12 months
measure: ZARIT score
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
References: