Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT03291535
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Hypertension Management Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure over time in control group vs. the intervention group', 'timeFrame': 'From enrollment to 6 months later', 'description': 'Difference in the change in blood pressure between the control group and intervention group.'}], 'secondaryOutcomes': [{'measure': 'Patient visits', 'timeFrame': 'From enrollment to 6 months later', 'description': 'Measurement of the number of in-person visits'}, {'measure': 'Patient remote interactions', 'timeFrame': 'From enrollment to 6 months later', 'description': 'Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist'}, {'measure': 'Medication changes', 'timeFrame': 'From enrollment to 6 months later', 'description': 'Number of changes in medication or medication dose'}, {'measure': 'Blood pressure control', 'timeFrame': 'From enrollment to 6 months later', 'description': 'Time to reach target blood pressure control (Adults 18-59 years of age \\<140/90 mm Hg, Adults 60-85 years of age, without a diagnosis of diabetes, \\<150/90 mm Hg, Adults 60-85 years of age, with a diagnosis of diabetes, \\<140/90 mm Hg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Electronic Health Record', 'Digital Health']}, 'descriptionModule': {'briefSummary': "Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure \\>140/90)\n\nExclusion Criteria:\n\n* Pregnancy\n* Chronic kidney disease III or IV\n* Systolic heart failure with ejection fraction \\<35%\n* Current use of 3 or more anti-hypertension drugs'}, 'identificationModule': {'nctId': 'NCT03291535', 'briefTitle': 'Virtual Hypertension Management Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.', 'orgStudyIdInfo': {'id': '12397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This arm will consist of the usual care of management of hypertension by a clinical pharmacist.', 'interventionNames': ['Other: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'This arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal.', 'interventionNames': ['Other: Connected-device']}], 'interventions': [{'name': 'Connected-device', 'type': 'OTHER', 'description': 'This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.', 'armGroupLabels': ['Intervention']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'This intervention will consist of usual clinical care as determined by the clinical pharmacist.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94028', 'city': 'Portola Valley', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Primary Care', 'geoPoint': {'lat': 37.38411, 'lon': -122.23524}}, {'zip': '95054', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Primary Care Clinic', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided, this is a quality improvement project.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Medicine', 'investigatorFullName': 'N. Lance Downing, MD', 'investigatorAffiliation': 'Stanford University'}}}}