Education Program in Myasthenia (MG-ETP)

Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Auto-immune Myasthenia
• Intervention / Treatment: Other: Therapeutic Education

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immediate PTE	Other: Therapeutic Education; 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.
OTHER: 6-month deferred PTE	Other: Therapeutic Education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brief Illness Perception Questionnaire	6 month after the first visit

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 22, 2021
• Primary Completion (ANTICIPATED): May 22, 2025
• Study Completion (ANTICIPATED): May 22, 2025

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 7534 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No