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Remote Patient Monitoring and Health Coaching for High Blood Pressure

N/A
Recruiting
Led By Steven Lin, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18+ years of age
Clinical diagnosis of hypertension
Must not have
<18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a digital program that includes personalized health coaching and remote patient monitoring can improve blood pressure control compared to usual care.

Who is the study for?
This trial is for English-speaking adults over 18 with high blood pressure who get their primary care at Stanford Primary Care. It's not open to those under 18, non-English speakers, or anyone already in the Omada Program.
What is being tested?
The study is testing the Omada Hypertension Program—a digital approach using a smartphone or website that includes health coaching and monitoring blood pressure remotely—against usual care methods for managing high blood pressure.
What are the potential side effects?
Since this trial involves a digital program rather than medication, traditional side effects are not expected. However, participants may experience stress or anxiety from regular health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Receives access to Omada Health programExperimental Treatment1 Intervention
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.
Group II: Does not receive access to Omada Health programActive Control1 Intervention
Participants manage hypertension with usual care alone.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,662 Total Patients Enrolled
Omada Health, Inc.Industry Sponsor
4 Previous Clinical Trials
952 Total Patients Enrolled
Steven Lin, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
99 Total Patients Enrolled

Media Library

Omada Hypertension Program Clinical Trial Eligibility Overview. Trial Name: NCT05394766 — N/A
High Blood Pressure Research Study Groups: Receives access to Omada Health program, Does not receive access to Omada Health program
High Blood Pressure Clinical Trial 2023: Omada Hypertension Program Highlights & Side Effects. Trial Name: NCT05394766 — N/A
Omada Hypertension Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394766 — N/A
~94 spots leftby Jul 2025