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NCT05394766 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05394766
Other study ID # 65790
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 29, 2022
Est. completion date July 2024

Study information
Verified date November 2023
Source Stanford University
Contact Steven Lin, MD
Phone 6507257966
Email stevenlin@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 550
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Stanford University Redwood City California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University Omada Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline in systolic blood pressure at 1-year Baseline, 1 year
Secondary Mean change from baseline in A1c at 1-year Baseline, 1 year
Secondary Mean change from baseline in weight at 1-year Baseline, 1 year
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