Mobile Health Program for High Blood Pressure

Overseen By Jared W Magnani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Heart failure, Acute coronary syndrome, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 6 months

334 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people in rural areas manage high blood pressure (hypertension) through a home-based program. Participants will use either a special smartphone app with coaching (Mobile Health Coaching Application) or a general health app (WebMD General Health Application) to monitor their blood pressure at home. The trial targets individuals who have struggled to control their high blood pressure and reside in designated rural counties. The study seeks to make blood pressure management easier and more effective for those with limited access to healthcare resources. As an unphased trial, it offers participants the chance to contribute to innovative solutions for managing hypertension in underserved communities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health program is safe for managing high blood pressure?

Research has shown that using smartphone apps for home-based blood pressure monitoring (HBPM) is generally safe. Studies have found that these apps help people manage their blood pressure effectively, with no serious safety concerns. For instance, one study found that a smartphone app for blood pressure monitoring was easy to use and helped users control their blood pressure without any major problems.

Another study demonstrated that people using a blood pressure monitor with a connected smartphone app achieved positive results in managing their blood pressure, with no significant safety issues. This indicates that using a smartphone app for blood pressure monitoring is both effective and safe.

Overall, evidence suggests that using a smartphone app to monitor blood pressure is a safe choice. It helps people keep track of their health without causing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how mobile health technology can improve blood pressure management at home. Unlike traditional treatments that rely on regular clinic visits and medications, this approach uses a smartphone app for interactive coaching and behavior modification, paired with a wireless blood pressure cuff for easy and accurate monitoring. This method enables users to receive real-time guidance and education on managing their condition, potentially leading to better adherence and outcomes for those with high blood pressure.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that a smartphone app for health coaching can help people manage high blood pressure. In this trial, participants in the intervention arm will use a smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring. One study found that people using this type of app experienced a noticeable drop in their systolic blood pressure (the top number in a blood pressure reading) after a few months. Another study showed that these apps help people remember to take their medications as prescribed, which is important for controlling blood pressure. The app offers personalized advice and feedback, aiding individuals in better managing their condition. Overall, these findings suggest that mobile health coaching can be a powerful tool for improving blood pressure control in people with high blood pressure. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for rural residents with uncontrolled high blood pressure who are on hypertension medication and can use a smartphone. They must speak English well enough for the study, not be pregnant or planning pregnancy soon, and not have severe health issues like recent heart failure or life-threatening conditions.

Inclusion Criteria

You live in one of the 48 counties considered rural by the Center for Rural Pennsylvania.

No plans to relocate from the area within 12 months of enrollment

I have high blood pressure that's not well-controlled, with specific readings on two visits.

Exclusion Criteria

I am scheduled for a major surgery soon.

I was hospitalized for heart failure within the last 3 months.

Institutionalized status (e.g., nursing home, incarceration)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month home-based blood pressure monitoring program with either a smartphone-based coaching application or a general health application

6 months

Visits at baseline and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of patient-reported outcomes and blood pressure management

6 months

Visit at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Coaching application
• Home-based blood pressure monitoring
• WebMD

Trial Overview The study tests a home-based blood pressure monitoring program against regular monitoring plus WebMD app usage. It aims to see if personalized coaching and education help manage hypertension better in rural areas.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

Group II: Enhanced usual care Active Control 2 Interventions

WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

Home-based blood pressure monitoring is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Home Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular disease prevention

Approved in European Union as Home Blood Pressure Monitoring for:

• Hypertension diagnosis
• Hypertension management
• Cardiovascular disease prevention

Approved in Canada as Home Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Self-measurement of blood pressure (SMBP) at home is an accurate method for diagnosing hypertension, showing higher specificity and predictive value compared to traditional office blood pressure measurements in a study of 64 untreated hypertensive patients.

The reproducibility of SMBP in standardized conditions is comparable to that of ambulatory blood pressure monitoring (ABPM), suggesting that with proper training, home measurements can be reliably used for hypertension diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring]. Divisón, J., Puras, A., Sanchis, C., et al.[2020]

The Reach Out mHealth intervention, which uses SMS text messaging for self-measured blood pressure (SMBP) monitoring, was well-received by participants, indicating its potential effectiveness in engaging hypertensive patients in managing their blood pressure.

Participants with higher engagement levels had better understanding and social support, while those with lower engagement or who withdrew from the trial faced more health-related social needs, suggesting that addressing these needs could improve participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. Hellem, AK., Whitfield, C., Casetti, A., et al.[2023]

In a study of 54 patients, self-reported home blood pressure measurements (HBPM) were generally accurate, with 85% of patients showing a difference of no more than 4 mmHg compared to real measurements.

However, in 15% of patients, particularly those with lower education levels, significant discrepancies were noted, suggesting that automated blood pressure monitoring (ABPM) or devices with memory storage may provide more reliable data for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of self-reported home blood pressure measurements with automatically stored values and ambulatory blood pressure. Nordmann, A., Frach, B., Walker, T., et al.[2019]

The Microlife WatchBP Home monitor is designed to provide accurate and unbiased self-blood pressure monitoring at home, following the European Society of Hypertension guidelines, which enhances its reliability for patients.

A pilot study indicated that the device is user-friendly and well-accepted by hypertensive patients, suggesting it could improve adherence to home blood pressure monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tool for reliable self-home blood pressure monitoring designed according to the European Society of Hypertension recommendations: the Microlife WatchBP Home monitor. Stergiou, GS., Jaenecke, B., Giovas, PP., et al.[2007]

In a study of 55 patients with hypertension, home blood pressure monitoring (HBPM) showed that office blood pressure readings were consistently higher than home readings, indicating that patients may be experiencing 'white coat syndrome' where anxiety during office visits raises blood pressure.

HBPM was effective in reclassifying about one third of patients' hypertension status, suggesting it could be a valuable tool for better managing blood pressure in diverse populations, particularly in identifying those who may be misclassified as uncontrolled when using only office measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in an ethnically diverse inner-city cardiology practice. Qureshi, G., Salciccioli, L., Clark, LT., et al.[2008]

The study will evaluate the effectiveness of self-measured blood pressure monitoring (SMBP) using cellular-enabled devices in safety-net clinics, targeting patients with hypertension and aiming to improve blood pressure management without needing Wi-Fi or Bluetooth.

It will compare three levels of implementation support for SMBP, including minimal support, protocol-based reminders, and pharmacist-led coaching, to determine which approach best helps patients achieve better blood pressure control and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study. Fontil, V., Khoong, EC., Green, BB., et al.[2023]

A survey of 320 non-participants in a home blood pressure monitoring (HBPM) program revealed that 70.2% still used blood pressure cuffs and 58% communicated their readings to healthcare providers, indicating that many who do not formally participate may still benefit clinically.

Barriers to full participation included personal factors like forgetfulness and time constraints, as well as clinic-related issues such as lack of doctor engagement, suggesting that future programs should enhance patient education and motivation to improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What keeps patients from adhering to a home blood pressure program? Huff, LS., Zittleman, L., DeAlleaume, L., et al.[2018]

In a nationwide survey of 5437 adults, only 20.1% of hypertensive subjects owned a home blood pressure monitor, highlighting a significant gap in self-management tools for hypertension, especially in developing countries.

Owning a blood pressure monitor was associated with a notable decrease in blood pressure readings, with reductions of 3.7 mmHg in systolic and 2.8 mmHg in diastolic pressure, suggesting that increasing access to these devices could improve hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home sphygmomanometers can help in the control of blood pressure: a nationwide field survey. Akpolat, T., Arici, M., Sengul, S., et al.[2021]

A review of 151 high blood pressure apps revealed that most only offer basic features like blood pressure monitoring, lifestyle advice, and information about hypertension, indicating a lack of comprehensive self-management support.

The presence of social support features was weakly correlated with download frequency, suggesting that users may value community engagement, while apps tailored for specific BP monitors received higher ratings, highlighting the importance of compatibility in user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps to Support Self-Management for People With Hypertension: Content Analysis. Hui, CY., Creamer, E., Pinnock, H., et al.[2020]

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]

Citations

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Effect of Home Blood Pressure Monitoring via a Smartphone ... This randomized clinical trial investigates the effect on blood pressure of an artificial intelligence smartphone coaching application (app) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714418304257

The Smart Hypertension Control Study The goal of this study is to investigate the effects of providing a smartphone-based hypertension health coaching app along with a home blood pressure monitor ...

3. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1516600/full

Effect of a digital blood pressure coach on hypertension ... Main Outcomes: The primary outcome was office systolic BP (oSBP) after 90–150 days in participants with uncontrolled hypertension (oSBP ≥140 ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251336932

Using mHealth to support health coaching for patients with ... The purpose of this study was to determine if patients with hypertension could better self-manage their disease by using automated mHealth including health ...

5. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(24)00480-4/abstract

Self-Monitoring of Blood Pressure and Feedback via ... The SMBP app with feedback is superior to SMBP alone in terms of systolic BP reduction and improved drug adherence in patients with hypertension ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8520130/

Assessment of Hypertension Control Among Adults ... This cohort study examines whether engagement with a hypertension self-management program with a blood pressure monitor and connected smartphone application ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210778925000133

Home blood pressure monitoring and mobile health ... A cross-sectional survey was conducted on HBPM practices/training and interest in using mobile health (mHealth) applications among pregnant persons.

8. nature.com nature.com/articles/s41746-021-00486-5

Mobile health strategies for blood pressure self ... This review aimed to describe the impact of mHealth interventions on blood pressure outcomes in populations with disparities in digital health use.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05546931

Mobile Health Program for Rural Hypertension A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure ...