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

NCT05394766 | Completed

• 1 other identifier: 65790
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in systolic blood pressure at 1-year

  Baseline, 1 year

Secondary Outcomes (2)

• Mean change from baseline in A1c at 1-year

  Baseline, 1 year

• Mean change from baseline in weight at 1-year

  Baseline, 1 year

Study Arms (2)

Does not receive access to Omada Health program

NO INTERVENTION

Participants manage hypertension with usual care alone.

Receives access to Omada Health program

EXPERIMENTAL

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.

Other: Omada Hypertension Program

Interventions

Omada Hypertension Program OTHER

The Omada Program: an online program that offers comprehensive lifestyle self-management support for hypertension.

Receives access to Omada Health program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Omada Health, Inc.: collaborator

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven Lin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 27, 2022
• Study Start: July 29, 2022
• Primary Completion: July 31, 2025
• Study Completion: April 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)