Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-07 @ 6:43 PM
Study NCT ID:
NCT06517134
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prescribing Patterns of Antihypertensive Drugs in Uncomplicated Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000959', 'term': 'Antihypertensive Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3325032}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GP demographics', 'timeFrame': '1 year', 'description': "age and gender of GPs, the urban or rural classification of the practice location (based on the GP's clinic postal code and DATASANTE tables from the French National Institute for Statistics and Economic Studies, INSEE), and the number of years in practice."}, {'measure': 'medical practice activities', 'timeFrame': '1 year', 'description': 'frequency of home visits and consultations, the total number of registered patients, the average number of visits or consultations per patient, the average patient age, the number of very low-income patients, and the prevalence of registered chronic diseases (notably diabetes mellitus and cardiovascular diseases).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'prescriptions', 'primary care'], 'conditions': ['Hypertension,Essential', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. The determinants shaping GPs' antihypertensive medication (AD) prescription patterns in the setting of hypertension remain ambiguous. This investigation sought to elucidate how GPs' characteristics and professional activities influence AD prescriptions. A cross-sectional study utilizing a sample of 2,165 GPs was conducted in Normandy, France, in 2019. The ratio of AD prescriptions to overall prescription volume was computed for each practitioner. GPs were classified as 'low' or 'high' AD prescribers based on the median of this ratio. The ratio was examined in relation to GPs' demographic and professional variables such as age, gender, practice setting, years of experience, consultation frequency, the demographics and socioeconomic status of their patient panels, and prevalence of chronic conditions in patients. These associations were explored using both univariate and multivariate analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participant pool for this study comprised GP characteristics and prescription practices within the Normandy region in northwestern France during the course of 2019. With a resident population of 3,325,032 as of January 1, 2019, and a total of 2,165 registered GPs, the study was well-situated to offer a representative analysis.\n\nIn order to focus on conventional full-time primary GP care, practitioners whose primary professional focus included specialties such as osteopathy, acupuncture, homeopathy, or nutrition were excluded. Furthermore, GPs with fewer than 300 annual consultations/visits (less than one per day), fewer than 2,000 annual drug prescriptions, no patients with any of the 30 chronic diseases that qualify for no-charge treatment under French law, or solely very low-income patients (eligible for no-charge GP visits as defined by French legislation) were also excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who had at least one visit to their GP in 2019 were included, but minors were omitted.\n\nExclusion Criteria:\n\n* minors'}, 'identificationModule': {'nctId': 'NCT06517134', 'briefTitle': 'Prescribing Patterns of Antihypertensive Drugs in Uncomplicated Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Association Between GP Characteristics and Prescription Patterns for Antihypertensive Drugs: A Cross-sectional Study in Normandy, France', 'orgStudyIdInfo': {'id': '24-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hypertensive subjects', 'interventionNames': ['Drug: Antihypertensive Agents']}, {'label': 'non-hypertensive subjects'}], 'interventions': [{'name': 'Antihypertensive Agents', 'type': 'DRUG', 'description': 'use of antihypertensive drugs', 'armGroupLabels': ['hypertensive subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14200', 'city': 'Caen', 'country': 'France', 'facility': 'Xavier Humbert', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of general practice', 'investigatorFullName': 'Xavier HUMBERT', 'investigatorAffiliation': 'University Hospital, Caen'}}}}