Education Program in Myasthenia

NCT04714658 | Unknown

• 1 other identifier: 7534
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Brief Illness Perception Questionnaire

  6 month after the first visit

Study Arms (2)

Immediate PTE

EXPERIMENTAL

Other: Therapeutic Education

6-month deferred PTE

OTHER

Other: Therapeutic Education

Interventions

Therapeutic Education 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; Immediate PTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: January 19, 2021
• Study Start: January 22, 2021
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: January 19, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share