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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) (AUTAP)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Proactive care pathway
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group : proactive course

Control group : optimized medical treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Parkinson disease questionnaire 39 (PDQ39)
Self-assessment questionnaire integrating 39 items evaluating quality of life of PD patients. Establish a score between 0 and 100.
MDS-UPDRS section II
This section evaluate the motor aspects of experiences in daily living. 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.
MDS-UPDRS section I
This section evaluate the non-motor aspects of experiences of daily living.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.
Clinical Global impression
Measured by the patient, the caregiver and the investigator. There are 2 components to the CGI (20): (i) the CGI-severity to assign a disease severity score from 1 to 7 (1=no disease; 7=very severe). (ii) the CGI-Improvement which establishes a score of improvement since the beginning of treatment between 1 and 7 (1=great improvement; 7=great deterioration)
MDS-UPDRS III and IV
This section evaluate the motor examination (III) and motor complications (IV).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.
QUIP RS
Questionnaire for impulsive-compulsive disorders in Parkinson's disease-rating scale. The score per question varies from 0 to 4. If the patient obtains a 0, it means that he/she does not have an impulse control disorder. On the contrary, if the patient gets a 4 it means that he/she has an impulse control disorder very often. The total score of the questionnaire varies between 0 and 112.
ZARIT score
Assessment of caregiver burden. The score varies between 0 and 88. Score < 20: mild "burden 21 < score < 40: mild to moderate "burden 41 < score < 60 : moderate to severe "burden 61 < score < 88 : severe "burden

Full Information

First Posted
May 17, 2022
Last Updated
June 8, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05405998
Brief Title
Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy (AUTAP)
Acronym
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group : proactive course
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group : optimized medical treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proactive care pathway
Intervention Description
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: before the installation of the pump, i.e. before the episode of hospitalization dedicated to the starting of the treatment; after the installation of the pump following the above mentioned hospitalization.
Primary Outcome Measure Information:
Title
Evaluation of autonomy
Description
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
Time Frame
6 months
Title
Unified Parkinson's disease rating scale (MDS-UPDRS), section VI (Schwab and England)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parkinson disease questionnaire 39 (PDQ39)
Description
Self-assessment questionnaire integrating 39 items evaluating quality of life of PD patients. Establish a score between 0 and 100.
Time Frame
6 months and 12 months
Title
MDS-UPDRS section II
Description
This section evaluate the motor aspects of experiences in daily living. 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.
Time Frame
6 months and 12 months
Title
MDS-UPDRS section I
Description
This section evaluate the non-motor aspects of experiences of daily living.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.
Time Frame
6 months and 12 months
Title
Clinical Global impression
Description
Measured by the patient, the caregiver and the investigator. There are 2 components to the CGI (20): (i) the CGI-severity to assign a disease severity score from 1 to 7 (1=no disease; 7=very severe). (ii) the CGI-Improvement which establishes a score of improvement since the beginning of treatment between 1 and 7 (1=great improvement; 7=great deterioration)
Time Frame
6 months and 12 months
Title
MDS-UPDRS III and IV
Description
This section evaluate the motor examination (III) and motor complications (IV).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.
Time Frame
6 months and 12 months
Title
QUIP RS
Description
Questionnaire for impulsive-compulsive disorders in Parkinson's disease-rating scale. The score per question varies from 0 to 4. If the patient obtains a 0, it means that he/she does not have an impulse control disorder. On the contrary, if the patient gets a 4 it means that he/she has an impulse control disorder very often. The total score of the questionnaire varies between 0 and 112.
Time Frame
6 months and 12 months
Title
ZARIT score
Description
Assessment of caregiver burden. The score varies between 0 and 88. Score < 20: mild "burden 21 < score < 40: mild to moderate "burden 41 < score < 60 : moderate to severe "burden 61 < score < 88 : severe "burden
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume HACHE
Phone
(0)4 91 38 43 98
Email
guillaume.hache@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire MORANDO
Phone
0(4) 91 38 21 83
Email
claire.morando@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
AP-HM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume HACHE

12. IPD Sharing Statement

Learn more about this trial

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

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