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Clinical Trials/NCT04714658
NCT04714658
Not yet recruiting
Not Applicable

Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis

University Hospital, Strasbourg, France0 sites100 target enrollmentJanuary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Auto-immune Myasthenia
Sponsor
University Hospital, Strasbourg, France
Enrollment
100
Primary Endpoint
Brief Illness Perception Questionnaire
Status
Not yet recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2021
End Date
May 22, 2025
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Brief Illness Perception Questionnaire

Time Frame: 6 month after the first visit

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