Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT02776566
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent time in therapeutic range (TTR)', 'timeFrame': 'Month 1, Month 2, Month 4, Month 7', 'description': 'TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files'}], 'secondaryOutcomes': [{'measure': 'Treatment Related Quality of Life', 'timeFrame': 'Baseline, Month 1, Month 7', 'description': 'It will be evaluated using a 25 item validated questionnaire that assesses limitations, hassles, and positive impact with a Cronbach alpha for each of 0.87, 0.88 and 0.78 respectively'}, {'measure': 'Anticoagulation Related Knowledge', 'timeFrame': 'Baseline, Month 1, Month 7', 'description': 'It will be measured with an instrument containing 29 items at different levels of difficulty to allow differences in patient knowledge to be evaluated and has a person reliability coefficient of 0.75.'}, {'measure': 'Adherence with Monitoring', 'timeFrame': 'Month 1, Month 2, Month 4, Month 7', 'description': 'It is defined as the INR test completed within 24 hours of scheduled time and measured via the Coaguchek® device in home or clinic.'}, {'measure': 'Self-Testing Competency (Intervention group only)', 'timeFrame': 'Baseline to 7 months', 'description': 'It is defined as the ability to attain an INR reading and provider observed technique.'}, {'measure': 'Self-Testing Accuracy (Intervention group only)', 'timeFrame': 'Baseline to 7 months', 'description': 'It is defined as the concordance of self-reported and device-stored INR measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anticoagulation', 'Anticoagulation Management', 'Self-Testing', 'Self-Management', 'Warfarin', 'Thromboembolism', 'Blood Coagulation Disorders', 'Health Disparities', 'Minorities', 'African American', 'Hispanic', 'Cardiovascular Disease', 'Models of Anticoagulation Care', 'Tele-Health', 'Home Self-Testing'], 'conditions': ['Thromboembolism', 'Blood Coagulation Disorders', 'Cardiovascular Disease', 'Vascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.', 'detailedDescription': 'Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.\n\nHypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.\n\nThe research objective of this proposal will be accomplished through 3 specific aims:\n\n1. Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.\n2. Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.\n3. Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 21 years of age\n* African American or Hispanic\n* English speaking\n* Has been on warfarin therapy \\> 3 months\n* Plan to be on warfarin therapy \\> 12 months\n* Willing ( or caregiver be willing) to do self-monitoring\n* Willing to be randomized\n\nExclusion Criteria:\n\n* Lack of access to a telephone\n* Moderate to severe dementia (if lacks caregiver)\n* Severe hearing impairment ( if lacks caregiver)\n* Blindness ( if lacks caregiver)\n* Life expectancy \\< 6 months\n* Antiphospholipid antibody syndrome'}, 'identificationModule': {'nctId': 'NCT02776566', 'briefTitle': 'Patient-Centered Anticoagulation Self-Monitoring in Minority Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Patient-Centered Anticoagulation Self-Monitoring in Minority Patients', 'orgStudyIdInfo': {'id': '2015-1193'}, 'secondaryIdInfos': [{'id': 'K23HL112908', 'link': 'https://reporter.nih.gov/quickSearch/K23HL112908', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anticoagulation Clinic', 'description': 'Usual care through pharmacist managed anticoagulation clinic\n\nAnticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.', 'interventionNames': ['Other: Patient Self-Monitoring vs Anticoagulation Clinic']}, {'type': 'EXPERIMENTAL', 'label': 'Patient Self-Monitoring', 'description': "In home self-monitoring and pharmacist guided education\n\nPatient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.", 'interventionNames': ['Other: Patient Self-Monitoring vs Anticoagulation Clinic']}], 'interventions': [{'name': 'Patient Self-Monitoring vs Anticoagulation Clinic', 'type': 'OTHER', 'description': "Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.\n\nAnticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.", 'armGroupLabels': ['Anticoagulation Clinic', 'Patient Self-Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Edith A Nutescu, PharmD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Edith A. Nutescu', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}