Education Program in Myasthenia

Not Applicable

Not yet recruiting

• Conditions: Auto-immune Myasthenia
• Interventions: Other: Therapeutic Education

• Registration Number: NCT04714658
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Study Start: 2021-01-22
• Primary Completion: 2025-05-22
• Study Completion: 2025-05-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6-month deferred PTE	Therapeutic Education	-
Immediate PTE	Therapeutic Education	-

Primary Outcome Measures

Name	Time	Method
Brief Illness Perception Questionnaire	6 month after the first visit