Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06130605
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subjects Perceived as Embarrassing During a Consultation in General Medical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'limitation of subjects addressed by gene, modesty and/or fear of judgment', 'timeFrame': 'Day 0', 'description': 'Proportion of patients who have ever restricted the subjects discussed during a general medical consultation by gene, modesty and/or fear of judgment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['general medical consultation', 'gene', 'modesty', 'fear of judgment'], 'conditions': ['General Practice']}, 'descriptionModule': {'briefSummary': "Optimal medical care requires transparency and honesty. However, it is not always easy to address some issues that may be considered too personal, intimate or taboo, such as mental health, sexuality, addiction and death. Patients' approach to these issues may be influenced by the profile of their general practitioner, or by the atmosphere of the consultation.\n\nThis retention of information by the patient, whether voluntary or not, can lead to adverse events related to care due to a misunderstanding between doctor and patient.", 'detailedDescription': 'The main objective is to describe the proportion of patients limiting the subjects addressed during a general medicine consultation by gene, modesty and/or fear of judgment The secondary objective is to study the factors associated with limitation of subjects addressed by patient by gene, modesty and/or fear of judgment during a general medicine consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people over the age of 18 agreeing to take part in the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* Agreeing to take part in the study\n\nExclusion Criteria:\n\n* Minors\n* Protected by law (guardianship, curatorship, safeguard of justice)\n* Refusing to take part in the study'}, 'identificationModule': {'nctId': 'NCT06130605', 'acronym': 'Gene-MG', 'briefTitle': 'Subjects Perceived as Embarrassing During a Consultation in General Medical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Subjects Perceived as Embarrassing During a Consultation in General Medical Practice', 'orgStudyIdInfo': {'id': '2023_RIPH_006_Gene-MG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'people over the age of 18', 'description': 'people over the age of 18.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collection', 'armGroupLabels': ['people over the age of 18']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Ufr Medecine Urca', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Université de Reims Champagne Ardenne', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Barbe Coralie, DR', 'role': 'CONTACT', 'email': 'coralie.barbe@univ-reims.fr', 'phone': '0326913665', 'phoneExt': '+33'}, {'name': 'CURRS CURRS, dr', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'THERY MERLAND Emilie, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Reims Champagne-Ardenne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}