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

NCT05405998 | Unknown

• 1 other identifier: 2021-A01424-37
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Evaluation of autonomy

  The patient will be considered autonomous if he/she does not need nursing care to manage his/her treatment and the pump for 15 days

  6 months

• Unified Parkinson's disease rating scale (MDS-UPDRS), section VI (Schwab and England)

  Gold standard in the evaluation of activity in daily living in PD patients. The score varies per question from 0 to 4. If the patient scores 0, it means that he/she does not have any particular problem related to the disease. On the contrary, if the patient obtains a score of 4 for a question, it means that the disease has a severe impact on his daily life.

  6 months

Secondary Outcomes (7)

• Parkinson disease questionnaire 39 (PDQ39)

  6 months and 12 months

• MDS-UPDRS section II

  6 months and 12 months

• MDS-UPDRS section I

  6 months and 12 months

• Clinical Global impression

  6 months and 12 months

• MDS-UPDRS III and IV

  6 months and 12 months

Study Arms (2)

Experimental group : proactive course

EXPERIMENTAL

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.

Other: Proactive care pathway

Control group : optimized medical treatment

NO INTERVENTION

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.

Interventions

Proactive care pathway 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.

Experimental group : proactive course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

AP-HM

Marseille, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• François CREMIEUX

  Assistance Publique - Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Guillaume HACHE

CONTACT

(0)4 91 38 43 98; guillaume.hache@ap-hm.fr

Claire MORANDO

CONTACT

0(4) 91 38 21 83; claire.morando@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 6, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

FR (1)