Remote Patient Monitoring and Health Coaching for High Blood Pressure

Overseen By Steven Lin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Under 18, Non-English, Omada Program

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

550 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding a digital program to your usual care, so you might not need to stop your medications.

What data supports the effectiveness of the Omada Hypertension Program treatment for high blood pressure?

Research shows that digital therapeutics, like the Omada Hypertension Program, can significantly reduce blood pressure in patients by using home monitoring and personalized remote treatment. Studies have demonstrated that these digital tools help patients achieve better blood pressure control compared to traditional methods. ^{1 2 3 4 5}

Is the Remote Patient Monitoring and Health Coaching for High Blood Pressure safe for humans?

The studies on digital therapeutics for hypertension, including apps and remote monitoring systems, have not reported any safety concerns, suggesting they are generally safe for human use. ^{2 4 5 6 7}

How is the Omada Hypertension Program treatment different from other treatments for high blood pressure?

The Omada Hypertension Program is unique because it uses remote patient monitoring and digital health coaching to help manage high blood pressure. This approach leverages home blood pressure measurements and digital communication to provide personalized care, which can improve patient adherence and control rates compared to traditional in-office visits. ^{1 5 8 9 10}

What is the purpose of this trial?

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.

Research Team

Steven Lin, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

English-speaking

I have been diagnosed with high blood pressure.

Receives primary care at Stanford Primary Care

Exclusion Criteria

I am under 18 years old.

Primary language not English

You are currently or were previously enrolled in the Omada Program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized health coaching and remote patient monitoring with a connected blood pressure cuff, delivered on a smartphone or website

12 weeks

Remote monitoring and virtual interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Omada Hypertension Program

Trial Overview 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.

Participant Groups

Group I: Receives access to Omada Health program Experimental Treatment 1 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 program Active Control 1 Intervention

Participants manage hypertension with usual care alone.

Omada Hypertension Program is already approved in United States for the following indications:

Approved in United States as Omada Hypertension Program for:

• Hypertension management

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Omada Health, Inc.

Industry Sponsor

Trials

5

Recruited

1,500+

Findings from Research

A remote hypertension management program was developed that uses home blood pressure monitoring and algorithmic care pathways, showing promise in helping patients achieve better blood pressure control.

The program involves non-licensed patient navigators working under the supervision of healthcare professionals, allowing for personalized medication adjustments based on patient-specific characteristics, which could enhance scalability and effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. Nichols, H., Cannon, CP., Scirica, BM., et al.[2022]

The HERB-Digital Hypertension 1 trial demonstrated that a hypertension treatment app significantly reduced blood pressure in patients, showing better results than traditional physician management alone.

This app received global approval in Japan in 2022, paving the way for its widespread use in managing hypertension, although further research is needed to identify which patients will benefit most and to establish guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. Kario, K., Harada, N., Okura, A.[2022]

A study involving 444 patients with uncontrolled hypertension will compare three approaches: traditional care, telemonitoring with office visits, and telemedicine using online communication, to see which method achieves better blood pressure control.

The primary goal is to determine which method leads to faster control of hypertension, with expectations that telemonitoring and telemedicine will be more effective and may improve patient adherence and satisfaction while potentially reducing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale and design of reduction of uncontrolled hypertension by Remote Monitoring and Telemedicine (REMOTE) study. Yatabe, MS., Yatabe, J., Asayama, K., et al.[2018]

Digital interventions, such as apps and web-based programs, have the potential to empower patients with hypertension to manage their condition more effectively, offering personalized support and potentially reducing healthcare costs.

This systematic review aims to evaluate the effectiveness of these digital tools on blood pressure control and other health outcomes, using data from randomized controlled trials to provide evidence for their use in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Interventions to Promote Self-Management in Adults With Hypertension: Protocol for Systematic Review and Meta-Analysis. McLean, G., Murray, E., Band, R., et al.[2022]

In a study of 7752 patients with primary hypertension, using a digital platform for home blood pressure monitoring and individualized treatment led to a 57% increase in the proportion of patients achieving controlled systolic blood pressure (SBP) after 360 days.

The greatest reduction in SBP was 13.8 mmHg in patients with high SBP, while improvements in blood pressure and other health factors like BMI and smoking were sustained over the 540-day study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics. Willis, M., Darwiche, G., Carlsson, M., et al.[2023]

A digital hypertension self-management program significantly reduced systolic blood pressure (SBP) by an average of 4.8 mm Hg over 12 months for all participants, and by 8.1 mm Hg for those with uncontrolled SBP at baseline, indicating its efficacy in managing hypertension.

Participants with uncontrolled SBP also experienced notable improvements in diastolic blood pressure, weight loss (average of 6.5 lbs), and body mass index (BMI), demonstrating the program's comprehensive impact on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. Wu, J., Napoleone, J., Linke, S., et al.[2023]

In a pilot study involving 19 hypertensive patients over six months, the Health data Monitoring System (HMS) led to an increase in patients reaching their blood pressure goals from 16% to 37%.

The mean home systolic blood pressure decreased significantly from 138.1 mmHg to 130.2 mmHg, suggesting that regular monitoring with HMS can effectively support hypertension management, especially in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. Kishi, T., Usui, H., Nagayoshi, S.[2023]

Home blood pressure telemonitoring (HBPT) has been shown to improve patient compliance and hypertension control rates, based on randomized controlled trials, although the overall evidence for blood pressure reduction is considered 'moderate'.

Despite the potential of digital health interventions, there is a lack of high-quality evidence regarding the accuracy and safety of mobile applications for hypertension management, indicating that not all available apps are suitable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. Postel-Vinay, N., Bobrie, G., Asmar, R., et al.[2023]

This systematic review aims to evaluate the effectiveness of remote health interventions using internet and mobile communication for managing hypertension, providing a comprehensive analysis of existing studies.

The review will compare these remote interventions to traditional nursing methods to determine if they offer better blood pressure control and improved patient compliance, based on data from multiple databases and rigorous statistical analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of remote health intervention based on internet or mobile communication network on hypertension patients: Protocol for a systematic review and meta-analysis of randomized controlled trials. Wu, Y., Zhao, P., Li, W., et al.[2022]

In a study of 374 hypertensive patients, remote patient monitoring, with or without physician care, was found to be as effective as traditional office care in reducing blood pressure over 24 weeks.

Patients over 55 years old showed significant improvements in blood pressure with remote monitoring, indicating that this approach can be beneficial for older adults managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. Kim, YN., Shin, DG., Park, S., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The rationale and design of reduction of uncontrolled hypertension by Remote Monitoring and Telemedicine (REMOTE) study. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

Digital Interventions to Promote Self-Management in Adults With Hypertension: Protocol for Systematic Review and Meta-Analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of remote health intervention based on internet or mobile communication network on hypertension patients: Protocol for a systematic review and meta-analysis of randomized controlled trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. [2018]