Home Monitoring for High Blood Pressure

Overseen By Lama Ghazi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Blood pressure >=160 mmHg

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether tracking blood pressure at home and having regular consultations with a pharmacist can help manage high blood pressure. Participants will either monitor their blood pressure from home using Remote Blood Pressure Monitoring and have weekly phone meetings with a pharmacist or continue with their regular doctor visits. The program lasts three months to assess the effectiveness and practicality of home monitoring. Individuals who visit the Emergency Department Post-Discharge Clinic, have high blood pressure, and own a smartphone may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in blood pressure management.

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

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study involves monitoring blood pressure and possibly adjusting medications if needed.

What prior data suggests that remote blood pressure monitoring is safe?

Research has shown that checking blood pressure at home is generally safe. Many studies indicate that this method helps manage high blood pressure. It involves measuring blood pressure at home and sending the results to a doctor.

One study found that this method can detect sudden changes in blood pressure, potentially preventing heart problems. Another study examined its safety and effectiveness, finding that people generally handle it well, with no major negative effects reported.

Overall, extensive research has established remote blood pressure monitoring as a safe way to track high blood pressure at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote blood pressure monitoring because it offers a new way to manage high blood pressure without frequent in-person visits to a healthcare provider. This method allows patients to regularly check their blood pressure from home and receive immediate feedback and guidance through telehealth consultations with pharmacists. Unlike traditional care, which relies on periodic office visits, this approach could lead to more consistent blood pressure control and quicker adjustments in treatment plans, potentially improving overall health outcomes.

What evidence suggests that remote blood pressure monitoring is effective for managing high blood pressure?

Research shows that checking blood pressure from home can greatly aid in keeping it under control. One study found that participants who used this method saw their top blood pressure number drop by an average of 14.1 points. This top number measures the pressure in blood vessels when the heart beats. Home monitoring also helps detect quick changes in blood pressure that might signal heart issues. In this trial, participants in the "Remote Blood Pressure Monitoring + Telehealth" arm will undergo remote monitoring combined with pharmacist-led telehealth intervention, which studies suggest enhances the effectiveness of home monitoring. Overall, monitoring blood pressure from home with expert assistance has proven effective in managing high blood pressure. ^{1 2 3 5 6}

Who Is on the Research Team?

Lama Ghazi, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure. It's designed to see if monitoring their own blood pressure at home and having weekly phone consultations with pharmacists can help manage their condition better than the usual care.

Inclusion Criteria

Patients seen at the Emergency Department Post-Discharge Clinic

English speakers

Have a smartphone

Exclusion Criteria

Patients with blood pressure equal to or greater than 160 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants measure blood pressure at home and have weekly telehealth consultations with a pharmacist for 3 months

3 months

Weekly phone consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Remote Blood Pressure Monitoring

Trial Overview

The study is testing a new approach where half of the participants will monitor their blood pressure at home and have weekly telehealth sessions with pharmacists, while the other half receives standard medical care without these additions.

How Is the Trial Designed?

Group I: Remote Blood Pressure Monitoring + Telehealth Active Control 1 Intervention

Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management

Group II: Usual Care Placebo Group 1 Intervention

Participants receive usual care from providers to manage their blood pressure

Remote Blood Pressure Monitoring is already approved in United States, European Union, Canada, China for the following indications:

Approved in United States as Home Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular risk reduction

Approved in European Union as Self-Measured Blood Pressure Monitoring for:

• Hypertension diagnosis
• Hypertension management
• Cardiovascular risk assessment

Approved in Canada as Telemonitoring of Blood Pressure for:

• Hypertension management
• Chronic disease management

Approved in China as Home Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Home blood pressure monitoring is an effective method for diagnosing and managing hypertension, providing better predictions of cardiovascular events and mortality compared to clinic measurements.

Regular self-monitoring encourages patient engagement in their health management, leading to improved adherence to treatment and lower blood pressure levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home monitoring of blood pressure. McGrath, BP.[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]

The Hyperlink trial demonstrated that a 12-month intervention combining home blood pressure telemonitoring with pharmacist case management significantly improved blood pressure control in adults with uncontrolled hypertension, achieving 71% control at 12 months compared to 53% in usual care.

Key factors contributing to the success of the intervention included strong patient-pharmacist relationships, individualized treatment plans, and frequent communication, which facilitated timely adjustments to antihypertensive medications and led to rapid blood pressure reductions within just 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists. Beran, M., Asche, SE., Bergdall, AR., et al.[2020]

In a 12-month trial involving 120 older adults (average age 79.5 years), combining home blood pressure telemonitoring with pharmacist-led case management did not significantly improve the achievement of target ambulatory blood pressure levels compared to usual care.

However, the intervention did lead to significant reductions in home blood pressure readings, although it also resulted in a higher incidence of hypotension (systolic BP < 110) without causing major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. Lau, D., Ringrose, J., McAlister, FA., et al.[2022]

A study involving 236 hypertensive patients found that antihypertensive treatment guided by telemonitoring of home blood pressure was as effective as traditional office-based monitoring in reducing systolic daytime blood pressure over 6 months.

Both groups experienced significant decreases in blood pressure, with the telemonitoring group showing a reduction of -11.9 mmHg compared to -9.6 mmHg in the control group, indicating that home monitoring can be a viable alternative for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. Madsen, LB., Kirkegaard, P., Pedersen, EB.[2008]

Home blood pressure monitoring is an important tool for diagnosing and managing high blood pressure, but it must be done using a standardized protocol to ensure accuracy.

Patients should use a validated automatic BP device, take measurements after resting for five minutes, and record readings over at least seven days to accurately assess their blood pressure, with an average of ≥135/85 mmHg indicating hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to measure home blood pressure: Recommendations for healthcare professionals and patients. Sharman, JE., Howes, F., Head, GA., et al.[2017]

Home blood pressure telemonitoring (HBPT) significantly lowers both systolic and diastolic blood pressure compared to usual care, with reductions of approximately 4.0 mmHg and 2.0 mmHg, respectively, based on a review of 46 randomized controlled trials involving 13,875 participants.

Patients using HBPT are more likely to achieve normalized blood pressure levels, and the intervention is even more effective when combined with additional support like counseling and education, suggesting that proactive engagement enhances its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. Duan, Y., Xie, Z., Dong, F., et al.[2023]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

Self-monitoring of blood pressure at home can enhance patient involvement in managing hypertension and may provide more accurate daily blood pressure readings compared to clinic measurements, potentially leading to better health outcomes.

Despite its benefits, self-monitoring devices often lack rigorous clinical validation, and current data is insufficient for making primary diagnostic decisions, meaning that clinical measurements should still take precedence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task force VI: Self-monitoring of the blood pressure. White, WB., Asmar, R., Imai, Y., et al.[2019]

Home blood pressure telemonitoring significantly reduced office blood pressure in hypertensive patients, with an average decrease of 5.64 mm Hg systolic and 2.78 mm Hg diastolic, based on 12 studies involving 4,389 participants.

Patients using telemonitoring had a 31% higher chance of normalizing their blood pressure compared to those receiving usual care, although the technique also led to a slight increase in the use of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Omboni, S., Guarda, A.[2011]

Home blood pressure monitoring is an effective and cost-efficient method for tracking blood pressure in hypertensive patients, providing better predictions of cardiovascular risk compared to traditional office measurements.

This technique not only enhances patient compliance and blood pressure control but also helps identify conditions like white coat hypertension and masked hypertension, making it a valuable tool in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in clinical practice: a review. Mallick, S., Kanthety, R., Rahman, M.[2009]

Home blood pressure telemonitoring enables patients to accurately measure and transmit their blood pressure data to healthcare providers, enhancing patient engagement in managing their hypertension.

Regular use of home BP telemonitoring has been shown to improve blood pressure control and reduce health complications related to high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What you need to know about home blood pressure telemonitoring: but may not know to ask. Artinian, NT., Washington, OG., Klymko, KW., et al.[2019]

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 home blood pressure telemonitoring (HBPT) in improving blood pressure control and reducing cardiovascular and kidney disease outcomes in non-dialysis chronic kidney disease (CKD) patients, based on a comprehensive search of multiple databases for relevant studies.

The review will include studies published up to 2020, ensuring a broad analysis of existing data, which will help inform healthcare strategies for managing hypertension in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home telemonitoring and management support on blood pressure control in non-dialysis CKD: a systematic review protocol. Okpechi, IG., Muneer, S., Tinwala, MM., et al.[2022]

Citations

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In addition, remote blood pressure monitoring can also help better control blood pressure in rural and low‐income population. Remote blood‐ ...

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Remote Blood Pressure Monitoring: A Comprehensive Review

This technology at home allows for the detection of instantaneous fluctuations in BP that could be predictive of cardiovascular disease events.

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Home Blood Pressure Telemonitoring With Remote ...

In the current study, >85% of enrolled participants completed the 6-month protocol with a 14.1 mm Hg mean reduction in systolic BP. Over 900 BP ...

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bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04278-6

Efficiency of remote monitoring and guidance in blood ...

Conclusions. Remote monitoring and guidance enhanced the efficiency of BP management, whereas self-monitoring alone proved to be ineffective.

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2838320

Lessons From a Remote Blood Pressure Monitoring Trial

Self-measured blood pressure monitoring at home: a joint policy statement from the American Heart Association and American Medical Association.

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Home Blood Pressure Telemonitoring with Remote ...

This study aimed to evaluate the feasibility, safety, and effectiveness of home BP telemonitoring with remote hypertension management among a predominately ...