Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-31 @ 5:24 PM
Study NCT ID:
NCT04731493
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008382', 'term': 'Marfan Syndrome'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life of children and young adults with Marfan', 'timeFrame': 'Base line', 'description': 'Answer to the question of PedsQL'}, {'measure': 'quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),', 'timeFrame': '3 months', 'description': 'Answer to the question of PedsQL'}, {'measure': 'quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),', 'timeFrame': '9 months', 'description': 'Answer to the question of PedsQL'}, {'measure': 'quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),', 'timeFrame': '12 months', 'description': 'Answer to the question of PedsQL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Marfan Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.', 'detailedDescription': 'During the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. The data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months.\n\nDuring the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (M9, M12) after the therapeutic Education Program (M6). The comparison between the evolution during the two phases, before and after the TEP will allow us to assess the benefits of the TEP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Marphan Syndrom', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria\n* For minors, no oral opposition from the holders of parental authority and consent of the minor.\n* For adults, no oral opposition collected\n* Patient affiliated to a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability)\n* Patient who has already participated in a TEP session for his pathology.\n* Protected adult: patient under legal guardianship or curator protection'}, 'identificationModule': {'nctId': 'NCT04731493', 'acronym': 'MYLIFE', 'briefTitle': 'Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study', 'orgStudyIdInfo': {'id': 'RC31/19/0505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'therapeutic Education Program', 'description': 'individual and group sessions will be set up with educational workshops specialized by age group (child / adolescent / transition / adult / entourage / parents), socio-administrative workshops, etc.\n\nThe objectives will be adapted to each age group and to each patient individually.', 'interventionNames': ['Other: Therapeutic Education Program']}], 'interventions': [{'name': 'Therapeutic Education Program', 'type': 'OTHER', 'description': '* needs assessment\n* educational group workshop\n* specialized workshops by age group: child / adolescent / transition / adult / entourage / separated parents and in parallel\n* socio-administrative workshop\n* individual summary (accompanied or not by his entourage / family)\n* satisfaction questionnaire', 'armGroupLabels': ['therapeutic Education Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Yves DULAC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}