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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am 18 years old or older.

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I have been diagnosed with high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Mean change from baseline in A1c at 1-year

Mean change from baseline in weight at 1-year

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,070 Total Patients Enrolled

Omada Health, Inc.Industry Sponsor

4 Previous Clinical Trials

1,052 Total Patients Enrolled

Steven Lin, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

39 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of people who can enroll in this trial?

"The answer is affirmative, the trial in question is still recruiting individuals according to the information available on clinicaltrials.gov. This specific study was posted on 7/29/2022 and updated for the last time on 8/2/2022. They are looking for 550 participants total, with recruitment happening at a single site."

Answered by AI

Are we currently accepting participants for this trial?

"That is correct. The listing on clinicaltrials.gov for this study shows that it is actively recruiting patients. This trial was posted on 29 July 2022 and updated on 2 August 2022. They are looking to enrol 550 people at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Steven Lin 2022. "Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394766.