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

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Other: Omada Hypertension Program

• Registration Number: NCT05394766
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-27
• Study Start: 2022-07-29
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receives access to Omada Health program	Omada Hypertension Program	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.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in systolic blood pressure at 1-year	Baseline, 1 year

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in A1c at 1-year	Baseline, 1 year
Mean change from baseline in weight at 1-year	Baseline, 1 year

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States