Education Program in Myasthenia

NCT ID: NCT04714658

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2025-05-22

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.

Conditions

Auto-immune Myasthenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Immediate PTE

Group Type: EXPERIMENTAL

Therapeutic Education

Intervention Type: OTHER

Each patient will participate in 1 to 3 PTE sessions.

1. st group collective workshop : allow the patient to better understand autoimmune

2. nd workshop : fatigue and techniques that enable its best management.

3. 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.

6-month deferred PTE

Group Type: OTHER

Therapeutic Education

Intervention Type: OTHER

Each patient will participate in 1 to 3 PTE sessions.

1. st group collective workshop : allow the patient to better understand autoimmune

2. nd workshop : fatigue and techniques that enable its best management.

3. 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.

Interventions

Therapeutic Education

Each patient will participate in 1 to 3 PTE sessions.

1. st group collective workshop : allow the patient to better understand autoimmune

2. nd workshop : fatigue and techniques that enable its best management.

3. 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

7534

Identifier Type: -

Identifier Source: org_study_id