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OpenTrials
Completed

NCT Number: NCT05394766

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omada Hypertension Program

Other

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

Primary outcomes

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

    Time frame: Baseline, 1 year

Secondary outcomes

  1. Mean change from baseline in A1c at 1-year

    Time frame: Baseline, 1 year

  2. Mean change from baseline in weight at 1-year

    Time frame: Baseline, 1 year

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Omada Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 27, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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