Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02480920
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence to New Oral Anticoagulation Therapy in Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vemren@hotmail.com', 'title': 'Volkan Emren', 'organization': 'Department of Cardiology, Afyonkarahisar State Hospital, Afyonkarahisar, Turkey'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Advers Events', 'description': 'The adverse effects, stroke, and any bleeding complication during NOAC treatment. Major bleeding was defined as a hemorrhage leading to a reduction in hemoglobin concentration of 2 g/dL, necessitating the transfusion of 2 or more units of blood, or symptomatic bleeding into a critical area or organ.', 'otherNumAtRisk': 2738, 'otherNumAffected': 0, 'seriousNumAtRisk': 2738, 'seriousNumAffected': 687}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2738, 'numAffected': 100}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bleeding', 'notes': 'Any bleeding (major or minor) complication during NOAC treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2738, 'numAffected': 577}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2738, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compliance of NOACs in Turkish Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Popülation: Who Received NOAC for More Than 3 Months', 'description': 'In order to identify the independent predictive variables that could affect the medication adherence of the patients with logistic regression analysis, the patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and nonadherent patients who had low adherence (Morisky score 5 or less).'}], 'classes': [{'title': 'low adherence', 'categories': [{'measurements': [{'value': '1342', 'groupId': 'OG000'}]}]}, {'title': 'high and medium adherence', 'categories': [{'measurements': [{'value': '1036', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.\n\nThe validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Popülation: Who Received NOAC for More Than 3 Months', 'description': 'This multicenter cross-sectional study was conducted between September 2015 and February 2016 in 45 centers encompassing all the geographical regions of Turkey. A total of 3150 patients were evaluated in this study. The 163 patients with a sociocultural level inadequate to fill the questionnaire and the 249 patients who received new oral anticoagulant for less than 3 months were excluded from the study. This study was conducted with the remaining 2738 patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2738'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2738'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Population', 'description': 'This multicenter cross-sectional study was consisted of patients who with non-valvular atrial fibrillation (NVAF) receiving Non-vitamin K antagonist oral anticoagulants NOACs), older than 18 years, who were followed up in cardiology clinics, and who received dabigatran (110-150 mg), rivaroxaban (15-20 mg), or apixaban (2.5-5 mg) for the last 3 months with \\>30 days of supply due to NVAF.\n\nThe patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and non-adherent patients who had low adherence (Morisky score 5 or less).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1623', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1115', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2738}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2015-06-19', 'resultsFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-22', 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance of NOACs in Turkish Population', 'timeFrame': '10 months', 'description': 'Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.\n\nThe validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation Drug Adherence', 'New Oral Anticoagulants', 'Drug Adherence'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.', 'detailedDescription': 'NOACs have several clinical and pharmacological advantages over warfarin however suboptimal adherence is one of the most common causes of failure to respond to medications and outcomes.\n\nThis observational multicenter, retrospective study, will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkey.\n\nSocial support and adherence to therapy factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires.\n\nNon-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years old\n* Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation\n* Patients signed patient informed sheet and informed consent form\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients refused to sign informed consent form'}, 'identificationModule': {'nctId': 'NCT02480920', 'acronym': 'NOAC-TR', 'briefTitle': 'Adherence to New Oral Anticoagulation Therapy in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular Academy Society, Turkey'}, 'officialTitle': 'Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey', 'orgStudyIdInfo': {'id': 'NOAC-TR'}}, 'contactsLocationsModule': {'locations': [{'city': 'Afyonkarahisar', 'country': 'Turkey (Türkiye)', 'facility': 'Volkan Emren', 'geoPoint': {'lat': 38.75667, 'lon': 30.54333}}], 'overallOfficials': [{'name': 'Volkan Emren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Academy Society, İzmir, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Academy Society, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}