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

NCT ID: NCT05394766

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2026-07-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Does not receive access to Omada Health program

Participants manage hypertension with usual care alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Receives access to Omada Health 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.

Group Type: EXPERIMENTAL

Omada Hypertension Program

Intervention Type: OTHER

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

Interventions

Omada Hypertension Program

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omada Health, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Steven Lin

Clinical Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Redwood City, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Lin, MD

Role: CONTACT

stevenlin@stanford.edu

6507257966

Facility Contacts

Steven Lin, MD

Role: primary

Other Identifiers

65790

Identifier Type: -

Identifier Source: org_study_id