Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 4:59 AM
Study NCT ID:
NCT06046560
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ablood3@mgb.org', 'phone': '617-732-7144', 'title': 'Alexander Blood, MD', 'organization': 'Mass General Brigham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The PAM Survey (Secondary Outcome) completion rate experienced low participant engagement: 90 participants missing baseline, 171 missing 60 day, and 159 missing 180 day.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later.', 'description': 'Adverse events were only assessed for participants who started a study medication.\n\nSerious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug.\n\nThe SAE definition also included urgent care visits.\n\nSystematic assessments were performed through phone call questionaires given to participants.\n\nNon-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.', 'eventGroups': [{'id': 'EG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 36, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 14, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Genital Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolemia', 'notes': 'Symptoms consistent with possible volume depletion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'notes': 'Glucose \\<70 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe hypoglycemia', 'notes': 'Glucose \\<70 mg/dL and requiring assistance from another person', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Any time between 0-months (baseline) to 6-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1-RA at any time', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short-form Patient Activation Measure (PAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': "Change in Short-form Patient Activation Measure (PAM)\n\nThe score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).\n\n0.0 - 1.0 (Disengaged \\& Overwhelmed)\n\n1.1 - 2.0 (Becoming Aware But Still Struggling)\n\n2.1 - 3.0 (Taking Action \\& Gaining Control)\n\n3.1 - 4.0 (Maintaining Behaviors \\& Pushing Further)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in body weight (kg)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Body Weight (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in body weight (%)', 'unitOfMeasure': '% weight change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Laboratory Measured HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'OG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in laboratory measured HbA1c', 'unitOfMeasure': '% change in HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'FG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.'}, {'id': 'BG001', 'title': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.\n\nSGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.\n\nEducation-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient\'s eligibility for therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Declined', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-09', 'size': 308975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-17T10:58', 'hasProtocol': True}, {'date': '2023-11-16', 'size': 225076, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-17T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'One group of patients, upon randomization, will immediately begin participation in a remote, pharmacist-driven clinic that will initiate and titrate medications according to a standardized medical algorithm. The comparator group will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2023-08-31', 'resultsFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-21', 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Body Weight (kg)', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in body weight (kg)'}, {'measure': 'Change in Body Weight (%)', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in body weight (%)'}, {'measure': 'Change in Laboratory Measured HbA1c', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': 'Change in laboratory measured HbA1c'}], 'primaryOutcomes': [{'measure': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time', 'timeFrame': 'Any time between 0-months (baseline) to 6-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1-RA at any time'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months', 'timeFrame': '2-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months'}, {'measure': 'Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months', 'timeFrame': 'At 6-months following enrollment', 'description': 'Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months'}, {'measure': 'Change in Short-form Patient Activation Measure (PAM)', 'timeFrame': 'From 0-months (baseline) to 6-months following enrollment', 'description': "Change in Short-form Patient Activation Measure (PAM)\n\nThe score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).\n\n0.0 - 1.0 (Disengaged \\& Overwhelmed)\n\n1.1 - 2.0 (Becoming Aware But Still Struggling)\n\n2.1 - 3.0 (Taking Action \\& Gaining Control)\n\n3.1 - 4.0 (Maintaining Behaviors \\& Pushing Further)"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Health', 'Remote Care Delivery', 'Team-based Care Model'], 'conditions': ['Cardiovascular Diseases', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '38302335', 'type': 'BACKGROUND', 'citation': 'Blood AJ, Chang LS, Colling C, Stern G, Gabovitch D, Feldman G, Adan A, Waterman F, Durden E, Hamersky C, Noone J, Aronson SJ, Liberatore P, Gaziano TA, Matta LS, Plutzky J, Cannon CP, Wexler DJ, Scirica BM. Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk. Prim Care Diabetes. 2024 Apr;18(2):202-209. doi: 10.1016/j.pcd.2024.01.005. Epub 2024 Feb 1.'}, {'pmid': '38583146', 'type': 'RESULT', 'citation': 'Blood AJ, Chang LS, Hassan S, Chasse J, Stern G, Gabovitch D, Zelle D, Colling C, Aronson SJ, Figueroa C, Collins E, Ruggiero R, Zacherle E, Noone J, Robar C, Plutzky J, Gaziano TA, Cannon CP, Wexler DJ, Scirica BM. Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial. Circulation. 2024 Jun 4;149(23):1802-1811. doi: 10.1161/CIRCULATIONAHA.124.069494. Epub 2024 Apr 7.'}]}, 'descriptionModule': {'briefSummary': "A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.", 'detailedDescription': 'A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study\'s primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '27 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 27 - 79 years at the time of agreeing to participate in the program\n2. Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)\n3. HbA1c 6.5-8.9%; AND\n4. At elevated cardiovascular and/or renal risk defined as any diagnosed ASCVD, estimated ASCVD risk \\>10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (LDL-c above 160 mg/dL or 4.1 mmol/L, non-HDL-C above 190 mg/dL or 4.9 mmol/L, triglycerides above 175 mg/dL,) hypertension (2 systolic blood pressure values above 130 mmHg and/or 2 diastolic blood pressure values above 90 mmHg within 12 months,) or BMI above 30\n5. Has seen a primary care provider within the Mass General Brigham network within the last year\n\nExclusion Criteria:\n\n1. Type 1 diabetes\n2. Currently or previously prescribed an SGLT2i or GLP1-RA\n3. Taking any short-acting insulin\n4. History of diabetic ketoacidosis\n5. History of hypoglycemia requiring hospitalization\n6. Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose \\<70 mg/dL\n7. eGFR below 15 ml/min/m2\n8. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR\n9. Life expectancy less than 1 year or utilizing palliative care'}, 'identificationModule': {'nctId': 'NCT06046560', 'acronym': 'DRIVE', 'briefTitle': 'Diabetes Remote Intervention to improVe Use of Evidence-based Medications', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications', 'orgStudyIdInfo': {'id': '2020P003822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medication & Education-First', 'description': 'Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.', 'interventionNames': ['Drug: SGLT2 inhibitor, GLP-1 RA']}, {'type': 'EXPERIMENTAL', 'label': 'Education-First', 'description': 'Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.', 'interventionNames': ['Drug: SGLT2 inhibitor, GLP-1 RA', 'Behavioral: Education-First']}], 'interventions': [{'name': 'SGLT2 inhibitor, GLP-1 RA', 'type': 'DRUG', 'description': 'Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.', 'armGroupLabels': ['Education-First', 'Medication & Education-First']}, {'name': 'Education-First', 'type': 'BEHAVIORAL', 'description': "For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.", 'armGroupLabels': ['Education-First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Benjamin M Scirica, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Harvard Medical School', 'investigatorFullName': 'Benjamin M. Scirica, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}