Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension

Stanford University

Status: Enrolling

Conditions: Hypertension

Treatments: Other: Omada Hypertension Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05394766

65790

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of hypertension
• 18+ years of age
• English-speaking
• Receives primary care at Stanford Primary Care

Exclusion criteria

• <18 years of age
• Primary language not English
• Active or prior enrollment in Omada Program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Does not receive access to Omada Health program

No Intervention group

Description:

Participants manage hypertension with usual care alone.

Receives access to Omada Health program

Experimental group

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.

Treatment:

Other: Omada Hypertension Program