Education Program in Myasthenia (MG-ETP)
Primary Purpose
Auto-immune Myasthenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Education
Sponsored by
About this trial
This is an interventional supportive care trial for Auto-immune Myasthenia
Eligibility Criteria
Inclusion Criteria:
- Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
- Patient agreeing to participate in the therapeutic education program
- Signing consent
- Subject affiliated with a health insurance social protection regiment
Exclusion Criteria:
- Patients without serological confirmation of myasthenia or pure ocular form
- Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
- Refusal of the patient to participate in the study
- Patient who has already benefited from the therapeutic education program in myasthenia
- Age < 18 y.o.
- Subject under safeguarding justice
- Subject under guardianship or under curatorship
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate PTE
6-month deferred PTE
Arm Description
Outcomes
Primary Outcome Measures
Brief Illness Perception Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04714658
First Posted
November 25, 2020
Last Updated
January 15, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04714658
Brief Title
Education Program in Myasthenia
Acronym
MG-ETP
Official Title
Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 22, 2021 (Anticipated)
Primary Completion Date
May 22, 2025 (Anticipated)
Study Completion Date
May 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. The main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. Secondary objectives are to assess quality of life, patient satisfaction of the PTE program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia Study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. By improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. Study team suppose that PTE program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auto-immune Myasthenia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate PTE
Arm Type
Experimental
Arm Title
6-month deferred PTE
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Therapeutic Education
Intervention Description
Each patient will participate in 1 to 3 PTE sessions.
st group collective workshop : allow the patient to better understand autoimmune
nd workshop : fatigue and techniques that enable its best management.
rd workshop : improving the management of the emotions generated by myasthenia. It allows patients to express their experiences of the disease in front of a group, to talk about their difficulties in their relationships and mobilize their resources to promote exchanges.
Primary Outcome Measure Information:
Title
Brief Illness Perception Questionnaire
Time Frame
6 month after the first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
Patient agreeing to participate in the therapeutic education program
Signing consent
Subject affiliated with a health insurance social protection regiment
Exclusion Criteria:
Patients without serological confirmation of myasthenia or pure ocular form
Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
Refusal of the patient to participate in the study
Patient who has already benefited from the therapeutic education program in myasthenia
Age < 18 y.o.
Subject under safeguarding justice
Subject under guardianship or under curatorship
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Education Program in Myasthenia
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