Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-25 @ 5:40 AM
Study NCT ID:
NCT00622102
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2008-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Strategies to Improving Warfarin Adherence
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': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], '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': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2008-01-15', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anticoagulation control', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'adherence', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['warfarin', 'adherence', 'Mechanical heart valves'], 'conditions': ['Atrial Fibrillation', 'Deep Venous Thrombosis', 'Dilated Cardiomyopathies']}, 'descriptionModule': {'briefSummary': "We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 21 years old age or older\n* On warfarin managed at the AC clinic\n* Target INR 2.0-3.0 or 2.5-3.5\n* At maintenance phase of therapy (defined as stable INR with stable warfarin dosing over at least 2 consecutive visits)\n\nExclusion Criteria:\n\n* Do not have access to telephone line\n* Unwillingness to participate or to sign a consent form(refusal)\n* Inability to participate because of advances dementia, advanced Alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the Med-eMonitor\n* Participation in a current study that does not permit participation in another study\n* End stage or terminal illness with anticipated life expectancy of 6 months or less\n* INR over the upper limit for the individual's range at the time of enrollment (e.g.,\\>3.0 or \\>3.5, depending on the target range)\n* Diagnosed with antiphospholipid antibody syndrome or abnormal INR prior to starting warfarin"}, 'identificationModule': {'nctId': 'NCT00622102', 'briefTitle': 'Testing Strategies to Improving Warfarin Adherence', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Testing Strategies to Improving Warfarin Adherence', 'orgStudyIdInfo': {'id': '806634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence', 'interventionNames': ['Behavioral: Lottery arm (Lottery and Med-eMonitor)']}, {'type': 'OTHER', 'label': '2', 'description': '50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence', 'interventionNames': ['Behavioral: Non-Lottery (Med-eMonitor only)']}], 'interventions': [{'name': 'Lottery arm (Lottery and Med-eMonitor)', 'type': 'BEHAVIORAL', 'description': 'Lottery and Med-eMonitor', 'armGroupLabels': ['1']}, {'name': 'Non-Lottery (Med-eMonitor only)', 'type': 'BEHAVIORAL', 'description': 'Med-eMonitor only', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania Anticoagulation Management Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kevin G Volpp, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aetna, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Stephen E. Kimmel, M.D., M.S.C.E.', 'oldOrganization': 'University of Pennsylvania School of Medicine'}}}}