Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 11:17 PM
Study NCT ID:
NCT05394766
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in systolic blood pressure at 1-year', 'timeFrame': 'Baseline, 1 year'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in A1c at 1-year', 'timeFrame': 'Baseline, 1 year'}, {'measure': 'Mean change from baseline in weight at 1-year', 'timeFrame': 'Baseline, 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'High blood pressure, also known as hypertension, affects nearly half of all Americans and increases the risk for heart disease and stroke. Only about half of people with high blood pressure have it under control. New methods to control blood pressure are needed to reduce heart attack and stroke rates. The purpose of this study is to test whether a digital program that includes personalized health coaching and remote patient monitoring with a connected blood pressure cuff, all delivered on a smartphone or website, can improve blood pressure control compared with usual care among patients with high blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypertension\n* 18+ years of age\n* English-speaking\n* Receives primary care at Stanford Primary Care\n\nExclusion Criteria:\n\n* \\<18 years of age\n* Primary language not English\n* Active or prior enrollment in Omada Program'}, 'identificationModule': {'nctId': 'NCT05394766', 'briefTitle': 'Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Pragmatic RCT of Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension', 'orgStudyIdInfo': {'id': '65790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Does not receive access to Omada Health program', 'description': 'Participants manage hypertension with usual care alone.'}, {'type': 'EXPERIMENTAL', 'label': 'Receives access to Omada Health program', 'description': "In addition to usual care, participants will gain access to the Omada Program, an online program that offers lifestyle self-management support for hypertension. Participants will be assigned a health coach and a hypertension specialist via Omada's secure app. Participants will receive hypertension education and resources and communicate with their care team through asynchronous, in-app messaging features. Participants will receive digital tools that connect with the Omada app to help track their food intake, physical activity, and blood pressure (BP). Participants who also have diabetes will receive a digital blood glucose meter and/or a continuous glucose monitor as well. The care team will support patients with lifestyle self-management support, adherence to their current medication regimen, improved BP control, and use of monitors for self-management of their BP and/or blood glucose values.", 'interventionNames': ['Other: Omada Hypertension Program']}], 'interventions': [{'name': 'Omada Hypertension Program', 'type': 'OTHER', 'description': 'The Omada Program: an online program that offers comprehensive lifestyle self-management support for hypertension.', 'armGroupLabels': ['Receives access to Omada Health program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Lin, MD', 'role': 'CONTACT'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'centralContacts': [{'name': 'Steven Lin, MD', 'role': 'CONTACT', 'email': 'stevenlin@stanford.edu', 'phone': '6507257966'}], 'overallOfficials': [{'name': 'Steven Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Omada Health, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor of Medicine', 'investigatorFullName': 'Steven Lin', 'investigatorAffiliation': 'Stanford University'}}}}