Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 7:48 PM
Study NCT ID:
NCT04714658
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2020-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Program in Myasthenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2025-05-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Illness Perception Questionnaire', 'timeFrame': '6 month after the first visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Auto-immune Myasthenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)\n* Patient agreeing to participate in the therapeutic education program\n* Signing consent\n* Subject affiliated with a health insurance social protection regiment\n\nExclusion Criteria:\n\n* Patients without serological confirmation of myasthenia or pure ocular form\n* Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures\n* Refusal of the patient to participate in the study\n* Patient who has already benefited from the therapeutic education program in myasthenia\n* Age \\< 18 y.o.\n* Subject under safeguarding justice\n* Subject under guardianship or under curatorship"}, 'identificationModule': {'nctId': 'NCT04714658', 'acronym': 'MG-ETP', 'briefTitle': 'Education Program in Myasthenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis', 'orgStudyIdInfo': {'id': '7534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate PTE', 'interventionNames': ['Other: Therapeutic Education']}, {'type': 'OTHER', 'label': '6-month deferred PTE', 'interventionNames': ['Other: Therapeutic Education']}], 'interventions': [{'name': 'Therapeutic Education', 'type': 'OTHER', 'description': 'Each patient will participate in 1 to 3 PTE sessions.\n\n1. st group collective workshop : allow the patient to better understand autoimmune\n2. nd workshop : fatigue and techniques that enable its best management.\n3. 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.', 'armGroupLabels': ['6-month deferred PTE', 'Immediate PTE']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}