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

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months.

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.

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring is generally considered safe for humans. It allows people to track their blood pressure at home, which can help manage conditions like high blood pressure. However, it's important to use validated devices to ensure accurate readings. ^{1 2 3 4 5}

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

Home blood pressure monitoring is unique because it allows patients to measure their blood pressure at home and share the data with healthcare providers remotely. This approach helps in better managing high blood pressure by engaging patients in their own care, improving adherence to treatment, and providing more accurate predictions of cardiovascular risk compared to traditional office measurements. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Remote Blood Pressure Monitoring, Home Blood Pressure Monitoring, Self-Measured Blood Pressure Monitoring, Telemonitoring of Blood Pressure?

Research shows that home blood pressure telemonitoring, combined with case management, can lead to better blood pressure control compared to usual care. Studies have found that this approach improves blood pressure levels in patients with hypertension (high blood pressure). ^{5 11 12 13 14}

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 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]

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]

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]

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]

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]

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 (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]

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]

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]

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 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 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]

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]

Citations

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

Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. [2023]

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

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. [2022]

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

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

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

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Task force VI: Self-monitoring of the blood pressure. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Impact of home telemonitoring and management support on blood pressure control in non-dialysis CKD: a systematic review protocol. [2022]

9. 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]

10. Australia pubmed.ncbi.nlm.nih.gov

How to measure home blood pressure: Recommendations for healthcare professionals and patients. [2017]

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

Home blood pressure monitoring in clinical practice: a review. [2009]

12. Australia pubmed.ncbi.nlm.nih.gov

Home monitoring of blood pressure. [2020]

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

What you need to know about home blood pressure telemonitoring: but may not know to ask. [2019]

14. China pubmed.ncbi.nlm.nih.gov

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