Back to resultsRemote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omada Hypertension Program
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Does not receive access to Omada Health program
Receives access to Omada Health program
Arm Description
Participants manage hypertension with usual care alone.
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.
Outcomes
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
Full Information
NCT ID
NCT05394766
First Posted
May 23, 2022
Last Updated
August 2, 2022
Sponsor
Stanford University
Collaborators
Omada Health, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05394766
Brief Title
Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Official Title
A Pragmatic RCT of Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Omada Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Does not receive access to Omada Health program
Arm Type
No Intervention
Arm Description
Participants manage hypertension with usual care alone.
Arm Title
Receives access to Omada Health program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Omada Hypertension Program
Intervention Description
The Omada Program: an online program that offers comprehensive lifestyle self-management support for hypertension.
Primary Outcome Measure Information:
Title
Mean change from baseline in systolic blood pressure at 1-year
Time Frame
Baseline, 1 year
Secondary Outcome Measure Information:
Title
Mean change from baseline in A1c at 1-year
Time Frame
Baseline, 1 year
Title
Mean change from baseline in weight at 1-year
Time Frame
Baseline, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Lin, MD
Phone
6507257966
Email
stevenlin@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lin, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Lin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
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