Remote Blood Pressure Monitoring for High Blood Pressure

(REACH Trial)

Overseen By Courtney Lyles, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 18, Controlled hypertension

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

Compensation: Varies

Number of Visits: 7

540 Participants Needed

Trial Summary

Is remote blood pressure monitoring safe for humans?

Remote blood pressure monitoring has been shown to be safe for use in humans, with studies indicating it can be effectively provided without face-to-face contact. The only identified risk was related to cleaning equipment during the COVID-19 pandemic, not the remote monitoring itself. ^{1 2 3}

How does remote blood pressure monitoring differ from other treatments for high blood pressure?

Remote blood pressure monitoring allows patients to measure their blood pressure at home and send the data to their healthcare provider, which can improve blood pressure control rates compared to usual care. This treatment is unique because it uses technology to facilitate frequent monitoring and communication without the need for regular in-person visits, making it especially beneficial for urban patients with easy access to healthcare. ^{2 3 4 5 6}

What is the purpose of this trial?

The goal of this study is to support patients with hypertension self-management using both home blood pressure monitors and digital messaging programs. The investigators will first engage patients with technology training to use home monitors, online portal websites to view their medical record information online, and texting and mobile phone applications. Then investigators will assess the effectiveness of home blood pressure monitors and enhanced patient-clinician digital communication on blood pressure control during a 12-month intervention.

Research Team

Courtney Lyles, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 within the San Francisco Health Network who have uncontrolled high blood pressure and are listed in the hypertension registry. Participants must be able to speak English or Spanish, have seen their primary care provider in the last two years, and either completed Aim 1 training or be willing to do so.

Inclusion Criteria

Patient within the San Francisco Health Network (SFHN)

Complete Aim 1 training, in addition to patients who have not completed Aim 1 training

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

My high blood pressure is under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Technology Training

Participants receive training on using home blood pressure monitors, online portals, and digital messaging applications

2-4 weeks

1-2 visits (in-person)

Intervention

Participants use home blood pressure monitors and engage in digital communication with healthcare providers to manage hypertension

12 months

Regular virtual check-ins and data monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up survey at 6 months

Treatment Details

Interventions

• Home Blood Pressure Monitoring
• Remote Monitoring

Trial Overview The study tests if using home blood pressure monitors along with digital tools like texting, mobile apps, and online medical records can help patients manage their high blood pressure better over a period of one year.

Participant Groups

Group I: Cellular Home blood pressure (BP) monitoring with minimal support Experimental Treatment 1 Intervention

Patients will be instructed to write down their blood pressures (BP) in a BP log that will be provided to them at the time of enrollment. Study staff will access the patient's home BP measurements on the BP device dashboard and send a summary of the home BP measurements (mean, median, % of BP measurements at goal) to the primary care provider in a telephone encounter (TE) 3 to 5 days prior to the next scheduled visit.

Group II: Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification Active Control 1 Intervention

For patients randomized to this intervention arm, a pharmacist will review the home blood pressure (BP) measurements and use an evidence-based algorithm to make recommendations for medication intensification. If the patient has a primary care provider (PCP) appointment within 2 weeks, the pharmacist will send a telephone encounter (TE) with BP measurements and medication recommendations to the PCP 3 -5 days prior to the scheduled appointment. If the patients has no appointment scheduled within two weeks, the pharmacist will call the patient and prescribe medication intensification if the patient is amenable.

Group III: Non-randomized usual care Active Control 1 Intervention

To compare the two intervention arms with usual care, investigators will extract electronic health record (EHR) data on active San Francisco Health Network (SFHN) adult patients (age 18+) with diagnosis of hypertension who made at least one primary care visit during the study period.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Remote ambulatory blood pressure monitoring (ABPM) can be safely and effectively conducted without face-to-face contact, as demonstrated by a study involving 65 participants, where 88% successfully completed the monitoring.

The study found no significant difference in measurement success rates between remote (88%) and face-to-face (89%) ABPM, indicating that remote methods can provide comparable results in hypertension management during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses. Armitage, LC., Lawson, BK., Roman, C., et al.[2022]

In a pilot trial involving 132 participants with hypertension, a remote blood pressure monitoring system led to a significant reduction in mean blood pressure from 137/85 to 132/78 mmHg over an average follow-up of 487 days.

The percentage of subjects achieving controlled blood pressure (<140/90 mmHg) increased from 47% to 66%, indicating the potential effectiveness of this monitoring system in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot test of a new tool for remote blood pressure monitoring. Boman, K., Brenander, A., Gustavsson, M., et al.[2019]

Remote blood pressure monitoring (RBPM) significantly reduces both systolic and diastolic blood pressure in urban patients with hypertension, with a decrease of approximately 4.5 mmHg in systolic and 2.1 mmHg in diastolic pressure compared to usual care.

Patients using RBPM also had a higher rate of blood pressure control, with a relative risk increase of 22.6%, indicating that RBPM is an effective strategy for managing hypertension in urban settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Updated Meta-Analysis of Remote Blood Pressure Monitoring in Urban-Dwelling Patients with Hypertension. Park, SH., Shin, JH., Park, J., et al.[2021]

In a study of 374 hypertensive patients, remote patient monitoring, with or without physician care, was found to be as effective as traditional office care in reducing blood pressure over 24 weeks.

Patients over 55 years old showed significant improvements in blood pressure with remote monitoring, indicating that this approach can be beneficial for older adults managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. Kim, YN., Shin, DG., Park, S., et al.[2018]

Remote monitoring of blood pressure using telemedicine technology can significantly improve the management of arterial hypertension, leading to better control of blood pressure levels in patients.

Implementing remote monitoring in Russia has shown promising results in achieving target blood pressure levels, which could ultimately reduce emergency care visits and lower the risk of serious cardiovascular events like strokes and heart attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realities and prospects of remote blood pressure monitoring in hypertensive patients. Boytsov, SA.[2019]

References

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

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses. [2022]

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

Effects of Remote Monitoring of Blood Pressure in Management of Urban Hypertensive Patients: A Systematic Review and Meta-Analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A pilot test of a new tool for remote blood pressure monitoring. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

An Updated Meta-Analysis of Remote Blood Pressure Monitoring in Urban-Dwelling Patients with Hypertension. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. [2018]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Realities and prospects of remote blood pressure monitoring in hypertensive patients. [2019]