A Pragmatic RCT of Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinical diagnosis of hypertension
• 18+ years of age
• English-speaking
• Receives primary care at Stanford Primary Care
Locations
United States
California
Stanford University
RECRUITING
Redwood City
Contact Information
Primary
Steven Lin, MD
stevenlin@stanford.edu
6507257966
Time Frame
Start Date: 2022-07-29
Estimated Completion Date: 2026-07
Participants
Target number of participants: 550
Treatments
No_intervention: Does not receive access to Omada Health program
Participants manage hypertension with usual care alone.
Experimental: Receives access to Omada Health program
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Omada Health, Inc.