Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-04 @ 4:30 AM
Study NCT ID:
NCT03917706
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '30 minutes', 'description': 'Quality of life will be assessed by means of a questionnaire adapted to adult patients suffering from congenital cardiopathy and having had surgery during childhood. There are 76 short closed questions, about 6 different domains (physical activity, social life, family life, professional life, scholarity, psychological comfort).'}], 'secondaryOutcomes': [{'measure': 'Medical antecedents', 'timeFrame': '30 minutes', 'description': 'List of medical antecedents of the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration.\n\nThere are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention.\n\nData from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease.\n\nMost studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life.\n\nThe investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults suffering from congenital heart disease, having had surgery during childhood, followed within the CHU Brugmann Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* congenital heart disease,\n* patients having had surgery during childhood,\n* patients followed within the CHU Brugmann Hospital.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03917706', 'briefTitle': 'Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood', 'orgStudyIdInfo': {'id': 'CHUB-congenital cardiopathy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital Heart Disease', 'description': 'Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.', 'armGroupLabels': ['Congenital Heart Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marine DENEUBOURG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Wauthy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director of the CHU Brugmann Hospital', 'investigatorFullName': 'Pierre Wauthy', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}