Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT03753035
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2018-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2018-11-22', 'studyFirstSubmitQcDate': '2018-11-22', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean compliance', 'timeFrame': '6 months', 'description': 'Mean compliance score measured by the validated Modified Morisky Medication Adherence Scales 8 for epileptic patients 11 subscale with a 5-point Likert scale. According to the scoring system for the MMAS, 8=high adherence, 6 to \\<8=medium adherence, and \\<6=low adherence. Patients who had a low or a moderate rate of adherence were considered nonadherent5.'}], 'secondaryOutcomes': [{'measure': 'Compliance score of the modified Modified Morisky Medication Adherence Scales 8', 'timeFrame': '6 months', 'description': 'distribution of responses to new items of the modified MMAS8 scale, internal structure)'}, {'measure': 'quality of life of epileptic children', 'timeFrame': '6 months', 'description': "Quality of life score measured by the IImpact of Pediatric Epilepsy Scale An 11-item scale was created for children and/or parents' use (according to age) to evaluate the influence of epilepsy on the major aspects of their family and child's life 5 items scale with a 5 point Likert scale"}, {'measure': 'syndromes', 'timeFrame': '6 months', 'description': 'MMAS8 compliance score according to syndromes and equilibrium of epilepsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epilepsy', 'children', 'seizures', 'patient compliance', 'quality of life'], 'conditions': ['Epilepsy', 'Children, Only', 'Quality of Life', 'Seizures', 'Patient Compliance']}, 'descriptionModule': {'briefSummary': 'There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all epileptic children at Nancy Children Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Child aged 5 to 17\n\n * Child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data\n * Holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child\n * Epileptic child\n * Follow-up at the neuro pediatric department of CHRU Nancy\n\nExclusion Criteria:\n\n* epileptic encephalopathy\n* Multiply handicapped child'}, 'identificationModule': {'nctId': 'NCT03753035', 'acronym': 'ObEPI', 'briefTitle': 'Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children', 'orgStudyIdInfo': {'id': 'ObEPI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'epileptic children', 'description': 'Completion of questionnaire, during medical consultation, on compliance and quality of life'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54520', 'city': 'Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barbara GIRARD', 'role': 'CONTACT', 'email': 'barbara.girard54@gmail.com', 'phone': '+33659302057'}], 'facility': 'GIRARD', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}