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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05394766
Enrollment
318
Registered
2022-05-27
Start date
2022-07-29
Completion date
2026-04-15
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

OTHEROmada Hypertension Program

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

Sponsors

Stanford University
Lead SponsorOTHER
Omada Health, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in systolic blood pressure at 1-yearBaseline, 1 year

Secondary

MeasureTime frame
Mean change from baseline in A1c at 1-yearBaseline, 1 year
Mean change from baseline in weight at 1-yearBaseline, 1 year

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSteven Lin, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026