Mobile Health Program for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).

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 data supports the effectiveness of the Mobile Health Program for High Blood Pressure treatment?

Research shows that home blood pressure monitoring (HBPM) can help control high blood pressure by involving patients in their own care, leading to a decrease in blood pressure levels. Additionally, owning a blood pressure monitor is associated with lower blood pressure readings, suggesting that self-monitoring is beneficial. ^{1 2 3 4 5}

Is the Mobile Health Program for High Blood Pressure safe for humans?

The research on home blood pressure monitoring (HBPM) and related mobile health applications suggests they are generally safe for humans, as they are widely used and recommended by health organizations for managing high blood pressure. However, issues like device inaccuracy and misreporting can occur, which are more about effectiveness rather than safety. ^{2 5 6 7 8}

How is home-based blood pressure monitoring different from other treatments for high blood pressure?

Home-based blood pressure monitoring (HBPM) is unique because it allows patients to measure their blood pressure at home, often using mobile health (mHealth) apps or text messaging for support, which can help them manage their condition more effectively and engage in self-care. This approach is different from traditional treatments that typically require regular visits to a healthcare provider for blood pressure checks. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• Coaching application (Behavioral Intervention)
• Home-based blood pressure monitoring (Behavioral Intervention)
• WebMD (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Home sphygmomanometers can help in the control of blood pressure: a nationwide field survey. [2021]

2. England 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. [2007]

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

Home blood pressure monitoring in an ethnically diverse inner-city cardiology practice. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of self-reported home blood pressure measurements with automatically stored values and ambulatory blood pressure. [2019]

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

What keeps patients from adhering to a home blood pressure program? [2018]

6. Spain 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]. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Apps to Support Self-Management for People With Hypertension: Content Analysis. [2020]

8. United States 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. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

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

10. Canada pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. [2023]