Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 8:18 AM
Study NCT ID:
NCT04888650
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-14', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE)', 'timeFrame': 'baseline', 'description': 'questionnaire To know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE)'}], 'secondaryOutcomes': [{'measure': 'comparaison of results with quebec', 'timeFrame': 'baseline', 'description': 'Comparison of the results of the French questionnaire, only the questions adapted from the Quebec questionnaire, with the results of the Quebec survey conducted by Jean-Nicolas Boursiquot in 2018.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hereditary Angioedema']}, 'descriptionModule': {'briefSummary': '8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec.\n\nMain objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with HAE with or without C1 inhibitor deficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with HAE with or without C1 inhibitor deficiency\n* Patient over 15 or parents of a child under 15 with HAE\n\nExclusion Criteria:\n\n* Patient opposed to the use of their data or refusing to answer the questionnaire\n* Adult patients protected by law'}, 'identificationModule': {'nctId': 'NCT04888650', 'acronym': 'BESQAOH', 'briefTitle': 'Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema', 'orgStudyIdInfo': {'id': '38RC21.054'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'angiodema hereditary patients', 'description': 'Patient with HAE with or without C1 inhibitor deficiency will respond to an electronic questionnaire', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'electronic questionnaire', 'armGroupLabels': ['angiodema hereditary patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'CHUGA', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}