Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04674202
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with a "satisfactory" knowledge score 3 months after hospital discharge', 'timeFrame': '3 months after hospital discharge', 'description': 'Knowledge of direct oral anticoagulants will be assessed with a 4 item questionnaire. The score ranges from 0 "no knowledge" to ≥ 3 "satisfactory knowledge".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Direct oral anticoagulants'], 'conditions': ['Atrial Fibrillation', 'Deep Vein Thrombosis', 'Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': "Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases.\n\nThis new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring.\n\nHowever, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®).\n\nTheir correct use requires the training and involvement of health professionals as well as information and support for patients.\n\nPharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care.\n\nThe purpose of these interviews is to:\n\n* Reinforce the pharmacist's advisory, educational and preventive roles with patients;\n* To enhance the pharmacist's expertise in the area of medication;\n* To evaluate the patient's knowledge of his or her treatment;\n* To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment;\n* To evaluate, in the long term, the patient's appropriation of his or her treatment.\n\nIn this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care.\n\nIn recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands.\n\nOn the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services.\n\nThe aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of patients hospitalized in a cardiology department with a discharge prescription for direct oral anticoagulants.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized for more than 48 hours in a cardiology department with a discharge prescription for curative anticoagulation.\n* Indication for a direct oral anticoagulant for atrial fibrillation, deep vein thrombosis or pulmonary embolism\n\nExclusion Criteria:\n\n* Patients treated for the prevention of venous thromboembolic disease who have undergone scheduled total hip replacement or total knee replacement surgery.\n* Patient with cognitive impairment\n* Patients with a previous prescription for a direct oral anticoagulant'}, 'identificationModule': {'nctId': 'NCT04674202', 'acronym': 'EDUC-AOD', 'briefTitle': "Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization", 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': "Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization", 'orgStudyIdInfo': {'id': '2020PPRC08'}, 'secondaryIdInfos': [{'id': '2020-A02285-34', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pharmaceutical interview', 'description': 'This group will benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated.', 'interventionNames': ['Other: Phone interview']}, {'label': 'No pharmaceutical interview', 'description': 'This group will not benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated.', 'interventionNames': ['Other: Phone interview']}], 'interventions': [{'name': 'Phone interview', 'type': 'OTHER', 'description': 'The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.', 'armGroupLabels': ['No pharmaceutical interview', 'Pharmaceutical interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93100', 'city': 'Montreuil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Albert BOCCARA, MD', 'role': 'CONTACT', 'email': 'albert.boccara@gmail.com', 'phone': '951706247', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Intercommunal de Montreuil', 'geoPoint': {'lat': 48.86415, 'lon': 2.44322}}, {'zip': '94160', 'city': 'Saint-Mandé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BOUVIER, MD', 'role': 'CONTACT', 'email': 'francois-rene.bouvier@intradef.gouv.fr'}], 'facility': "Hôpital d'Instruction des Armées Bégin", 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}], 'centralContacts': [{'name': 'Samuel COHEN', 'role': 'CONTACT', 'email': 'samuel.cohen4@aphp.fr', 'phone': '635192704', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}