Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 8:50 AM
Study NCT ID:
NCT01963156
Status:
TERMINATED
Last Update Posted:
2016-01-11
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synchronization to Improve Non-Adherence to Cardiovascular Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3675}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of de-synchronization', 'timeFrame': '12 months', 'description': 'Rate at which members whose prescriptions have been synchronized elect to discontinue with the synchronization during the study period'}], 'primaryOutcomes': [{'measure': 'Medication adherence', 'timeFrame': '12 months', 'description': 'Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims'}], 'secondaryOutcomes': [{'measure': 'Full adherence to medications for the treatment of diabetes or cardiovascular disease', 'timeFrame': '12 months', 'description': 'Percent of subjects achieving full adherence (defined as a Medication Possession Ratio \\> 80%) to medications for cardiovascular disease and diabetes'}]}, 'conditionsModule': {'keywords': ['Prescription synchronization', 'Cardiovascular disease', 'Medication adherence', 'Randomized controlled trial', 'Chronic disease', 'Pharmacy benefit design', 'Quality improvement'], 'conditions': ['Chronic Disease', 'Cardiovascular Disease', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'We will enroll patients 18 years of age and older who within 6 months of study enrollment have filled ≥ 2 medications intended for long-term use (i.e. maintenance medications) by mail order at CVS Caremark. At least 1 of these 2 medications of must be for the treatment of diabetes or cardiovascular disease. In addition, these medications must be delivered on two or more unique delivery dates, there must be at least one refill remaining for all eligible medications and either all or none of their prescriptions must be enrolled in the ReadyFill@Mail program (see Intervention Description for details).'}, 'identificationModule': {'nctId': 'NCT01963156', 'acronym': 'SyNCMed', 'briefTitle': 'Synchronization to Improve Non-Adherence to Cardiovascular Medications', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)', 'orgStudyIdInfo': {'id': 'Pro00008813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prescription synchronization', 'interventionNames': ['Behavioral: Prescription synchronization']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Prescription synchronization', 'type': 'BEHAVIORAL', 'description': 'Each patient\'s medication that has the greatest quantity of pills on hand after randomization will be defined as the "index "medication and partial supplies will be provided for all other eligible medications in order to synchronize all of a patient\'s medication. Prescribers will be contacted for a new prescription to ensure all eligible medications are on the same renewal schedule.\n\nRandomization will occur within strata of whether patients are enrolled in the "ReadyFill@Mail" program. Once synchronized, patients who are not enrolled in the ReadyFill@Mail program will initiate their own refills. Patients who are enrolled in the ReadyFill@Mail program will have their refills automatically filled, however patients may disenroll from ReadyFill@Mail at any time, in which case they will initiate their own refills. Patients may disenroll in whole or in part from the program at any point.', 'armGroupLabels': ['Prescription synchronization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02895', 'city': 'Woonsocket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'CVS Caremark', 'geoPoint': {'lat': 42.00288, 'lon': -71.51478}}], 'overallOfficials': [{'name': 'Niteesh K Choudhry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital/Harvard Medical School"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'CVS Caremark', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Harvard Medical School', 'investigatorFullName': 'Niteesh K. Choudhry, MD, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}