Remote Management for High Blood Pressure

(RHYTHM-B Trial)

Overseen By Leslie Teague

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

Trial Summary

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.

What data supports the effectiveness of the treatment RHYTHM (Remote Hypertension Tracking Help Management) for high blood pressure?

Research shows that remote monitoring of blood pressure, like in the RHYTHM program, can help lower blood pressure levels. For example, one study found that using remote monitoring systems led to a decrease in average blood pressure from 137/85 to 132/78 mmHg. ^{1 2 3 4 5}

Is remote management for high blood pressure safe for humans?

The studies on remote management for high blood pressure, such as remote physiologic monitoring (RPM) and nurse-coordinated telemonitoring, do not report any specific safety concerns, suggesting it is generally safe for humans. ^{1 2 3 6 7}

How does the RHYTHM treatment for high blood pressure differ from other treatments?

The RHYTHM treatment is unique because it uses remote monitoring to track blood pressure at home and automatically sends this data to healthcare providers, allowing for more frequent and accurate adjustments to care compared to traditional methods. ^{1 2 3 6 8}

What is the purpose of this trial?

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Research Team

Yhenneko J. Taylor, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

My kidney function is very low or I am on dialysis, but I don't have a kidney transplant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States 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. [2023]

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

A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

A remote hypertension management program clinical algorithm. [2022]

6. England 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Nurse-Coordinated Blood Pressure Telemonitoring for Urban Hypertensive Patients: A Systematic Review and Meta-Analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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