Remote Management for High Blood Pressure

(RHYTHM-B Trial)

Overseen By Asha Ganesan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, Long-term care, eGFR<30, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

864 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage high blood pressure in Black patients whose blood pressure is not well-controlled. It compares two approaches: one uses a home blood pressure monitor with pharmacist and community health worker support (RHYTHM: Remote Hypertension Tracking Help Management), while the other involves regular clinic visits and a home monitor (Enhanced usual care). Black or African American individuals who have been diagnosed with high blood pressure and struggle to control it might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve hypertension management for Black communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that checking blood pressure from home is generally safe and easy to manage. Studies have found that using these devices can help control and improve high blood pressure while reducing treatment side effects. This method provides ongoing information, enhancing the diagnosis and management of high blood pressure.

For the RHYTHM (Remote Hypertension Tracking Help Management) program, early results from similar studies suggest that monitoring blood pressure from home, combined with remote medication management and support from community health resources, can be effective without major safety concerns. This type of remote care has been used successfully in other situations, such as during pregnancy, without significant problems.

These studies suggest that using technology to manage high blood pressure from home can be a safe option for many people. However, as with any medical approach, participants in clinical trials should discuss possible risks with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Hypertension Tracking Help Management (RHYTHM) approach because it offers a comprehensive, tech-driven method to manage high blood pressure. Unlike traditional treatments that primarily focus on medication and occasional doctor visits, RHYTHM integrates home blood pressure telemonitoring with remote medication management and social support. It also emphasizes lifestyle education and connects patients to community resources to address social needs, making it a holistic solution. This approach could lead to more personalized care and potentially better outcomes for patients with hypertension.

What evidence suggests that this trial's treatments could be effective for managing high blood pressure?

This trial will compare two approaches for managing high blood pressure: Enhanced Usual Care (UC) and RHYTHM (Remote Hypertension Tracking Help Management). Studies have shown that managing high blood pressure remotely can effectively lower blood pressure levels. Specifically, research indicates that remote monitoring reduced the average blood pressure in patients with uncontrolled hypertension by 8.5 mmHg. Another study found that patients using remote management experienced a significant drop in their systolic blood pressure compared to those receiving usual care, with a difference of 3.8 mmHg. This method offers more timely and continuous monitoring than traditional approaches, potentially leading to better results. However, some evidence suggests that adding social support to remote monitoring does not always enhance blood pressure control. ^{2 6 7 8 9}

Who Is on the Research Team?

Yhenneko J. Taylor, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for Black patients who have high blood pressure that isn't well-controlled. Participants will need to be comfortable with using a home blood pressure monitor and engaging in remote communication for the duration of the study.

Inclusion Criteria

Black or African American race

Uncontrolled blood pressure as defined by two most recent consecutive blood pressure readings

Primary care provided at a participating clinic

Exclusion Criteria

Currently pregnant or planning to get pregnant during the study period

Residence in a long-term care facility, hospice, or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team

Currently participating in another blood pressure management program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of blood pressure and other health metrics are taken

1-2 weeks

Treatment

Participants receive either home BP telemonitoring with pharmacist support or enhanced usual care

18 months

Follow-up

Participants are monitored for blood pressure control and healthcare utilization

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care (UC)
• RHYTHM (Remote Hypertension Tracking Help Management)

Trial Overview

The study is testing two methods of managing high blood pressure. One group will use a home BP telemonitoring system with support from pharmacists and community health workers, while the other will receive standard clinic care plus a home BP monitor.

How Is the Trial Designed?

Group I: RHYTHM (Remote Hypertension Tracking Help Management) Experimental Treatment 1 Intervention

home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs

Group II: Enhanced usual care (UC) Experimental Treatment 1 Intervention

standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A pharmacist-led home blood pressure monitoring (HBPM) intervention significantly improved blood pressure control, with 54.1% of participants achieving their BP goals compared to 35.4% in usual care after 6 months.

Patients in the HBPM group experienced greater reductions in blood pressure (systolic BP reduced by -12.4 mm Hg and diastolic BP by -5.7 mm Hg) and reported higher satisfaction with their hypertension care compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Magid, DJ., Olson, KL., Billups, SJ., et al.[2022]

A study involving 288 Medicare patients using remote patient monitoring (RPM) for hypertension showed significantly better blood pressure control at 3 and 12 months compared to 1152 matched controls, with 71.5% of RPM patients achieving BP control versus 58.1% in controls after 12 months.

RPM patients also had lower average systolic blood pressure (132.3 mm Hg) compared to controls (136.5 mm Hg) after 12 months, indicating that RPM can enhance hypertension management in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. Petito, LC., Anthony, L., Peprah, Y., et al.[2023]

The integration of Omron VitalSight remote physiologic monitoring (RPM) into electronic health records showed improved blood pressure control in patients with hypertension, with 31.4% of uncontrolled hypertension patients achieving control compared to 22.8% in matched controls after 6 months.

Despite low uptake of RPM among physicians (only 10 prescribing to 118 patients), the results suggest that RPM may enhance physician awareness and management of hypertension, indicating a potential benefit in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. Petito, LC., Anthony, L., Peprah, YA., et al.[2023]

A remote hypertension management program was developed that uses home blood pressure monitoring and algorithmic care pathways, showing promise in helping patients achieve better blood pressure control.

The program involves non-licensed patient navigators working under the supervision of healthcare professionals, allowing for personalized medication adjustments based on patient-specific characteristics, which could enhance scalability and effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. Nichols, H., Cannon, CP., Scirica, BM., et al.[2022]

Nurse-coordinated home blood pressure telemonitoring (NC-HBPT) significantly reduced systolic blood pressure by 5.731 mmHg and diastolic blood pressure by 2.342 mmHg compared to in-person treatment, indicating its efficacy in managing hypertension during the COVID-19 pandemic.

The rate of achieving target blood pressure levels was also significantly higher in the NC-HBPT group, with a risk ratio of 1.261, suggesting that this method is effective in improving blood pressure control among urban hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Coordinated Blood Pressure Telemonitoring for Urban Hypertensive Patients: A Systematic Review and Meta-Analysis. Choi, WS., Kim, NS., Kim, AY., et al.[2023]

In a study of 347 heart failure patients, non-invasive remote patient management (RPM) significantly increased the detection rate of new-onset atrial fibrillation (AF) to 5.1% compared to 1.2% in usual care (UC), highlighting RPM's effectiveness in monitoring heart conditions.

Patients using RPM experienced a significant reduction in days lost due to unplanned cardiovascular hospitalizations (5.5% in RPM vs. 14.6% in UC), particularly for hospitalizations related to AF, suggesting improved outcomes with RPM in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of atrial fibrillation in patients with heart failure reduces the risk of subsequent hospitalization: a subanalysis of the randomized TIM-HF2 trial. Stegmann, T., Koehler, K., Schulze, M., et al.[2023]

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 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]

Citations

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Comparing Remote High Blood Pressure Management ...

This study compares the effectiveness of managing blood pressure remotely through phone and video visits versus usual care at a doctor's office.

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Efficiency of remote monitoring and guidance in blood ...

This result shows that remote intervention is more effective in reducing BP, and surpassed other strategies with superior timeliness, continuity ...

4.

nature.com

nature.com/articles/s41371-023-00850-w

Blood pressure outcomes at 12 months in primary care ...

On average, RPM-prescribed patients had lower systolic BP than matched controls after 12 months (marginal mean difference [MMD] −3.8 mm Hg; 95% ...

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2819402

Remote Blood Pressure Monitoring With Social Support for ...

Findings of this trial indicate that neither remote monitoring of BP alone nor combined with social support result in improved BP control in adults with ...

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clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06527794

Remote Hypertension Management for Black Patients

Study Overview. Brief Summary. This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP).

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9903197/

Is remote blood pressure monitoring and management a ...

Their results suggest that telemetric blood pressure monitoring may help in the management and improvement of hypertension during pregnancy ...

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academic.oup.com

academic.oup.com/ajh/advance-article/doi/10.1093/ajh/hpaf097/8154826

Remote Blood Pressure Monitoring: A Comprehensive Review

These devices may enhance hypertension diagnosis and management by offering continuous data while limiting adverse treatment effects.

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psnet.ahrq.gov

psnet.ahrq.gov/perspective/remote-patient-monitoring

Remote Patient Monitoring | PSNet - AHRQ

RPM is a type of telehealth in which healthcare providers monitor patients outside the traditional care setting using digital medical devices.