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Home Monitoring for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen byLama Ghazi, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Blood pressure >=160 mmHg

Approved in 4 Jurisdictions

Trial Summary

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.

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).¹ ² ³ ⁴ ⁵

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.³ ⁶ ⁷ ⁸ ⁹

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.¹⁰ ¹¹ ¹² ¹³ ¹⁴

Research Team

Lama Ghazi, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

See 2 more

Exclusion Criteria

Patients with blood pressure equal to or greater than 160 mmHg

Trial Timeline

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

Treatment Details

Interventions

Remote Blood Pressure Monitoring (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Remote Blood Pressure Monitoring + TelehealthActive Control1 Intervention

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

Group II: Usual CarePlacebo Group1 Intervention

Participants receive usual care from providers to manage their blood pressure

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

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Dr. Eliseo J. Pérez-Stable

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Executive Officer since 2015

MD from University of Miami

Dr. Rada Dagher

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Medical Officer since 2024

MD from University of California, San Francisco

Findings from Research

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 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]