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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Auto-immune Myasthenia

Eligibility Criteria

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

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

    First Posted
    November 25, 2020
    Last Updated
    January 15, 2021
    Sponsor
    University Hospital, Strasbourg, France
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    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

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    Education Program in Myasthenia

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