16895 Participants Needed

RBPM + MII for High Blood Pressure

(BHEAT Trial)

Recruiting at 6 trial locations
MF
JS
Overseen ByJustine Scott, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better ways to manage high blood pressure (hypertension), a condition that can lead to serious health issues like stroke and heart attacks. It tests two approaches: remote blood pressure monitoring (RBPM) and team-based strategies to adjust treatment as needed. Suitable participants are adults diagnosed with hypertension, those taking blood pressure medication, or those with high readings whose blood pressure is not well-controlled. The study targets diverse communities in urban areas to enhance blood pressure management where it's most needed. As an unphased trial, it offers participants the chance to contribute to innovative strategies for managing hypertension in these 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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that remote blood pressure monitoring (RBPM) is generally easy for people to use. Studies indicate that RBPM provides extensive information about blood pressure patterns, aiding in the management of high blood pressure. In one trial, patients using RBPM received regular reminders to report their blood pressure and medication, and no major safety issues emerged.

For Multilevel Intensification Interventions (MII), which involve team efforts to improve treatment, results vary. Some studies have shown better blood pressure control, while others are less clear about the benefits. However, the reviewed studies noted no major safety concerns.

Both RBPM and MII are under study to manage high blood pressure safely, with no major adverse effects reported so far.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for high blood pressure because they introduce innovative ways to manage the condition. Remote Blood Pressure Monitoring (RBPM) offers a cutting-edge approach by allowing patients to track their blood pressure from home, providing real-time data to healthcare providers. This method can lead to more personalized and immediate adjustments to treatment plans. Meanwhile, Multilevel Intensification Interventions (MII) aim to address the common issue of clinical inertia, which is the failure to adjust treatment despite poor control of blood pressure. By using a team-based approach, MII enhances the likelihood of timely and effective treatment adjustments. Together, these methods promise a more dynamic and responsive management of high blood pressure compared to traditional medication-based approaches.

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

This trial will compare Remote Blood Pressure Monitoring (RBPM) with Multilevel Intensification Interventions (MII) for managing high blood pressure. Research has shown that checking blood pressure from home with RBPM can help lower it. In one study, participants using RBPM saw their top blood pressure number drop by an average of 7.3 points, and by as much as 16.7 points for those with very high blood pressure. Another study found that 90% of participants maintained healthy blood pressure levels for up to 42 months after using remote monitoring.

In contrast, MII has shown mixed results. Some studies indicate these methods can help control blood pressure, but others reveal varying effectiveness among individuals. MII aims to ensure treatment is adjusted quickly if blood pressure isn't under control. Overall, RBPM has more consistent evidence of effectiveness, while MII shows promise but doesn't always produce the same results.12367

Who Is on the Research Team?

MF

Michael Fischer, MD MS

Principal Investigator

Boston Medical Center, Internal Medicine

CC

Cheryl Clark, MD ScD

Principal Investigator

Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high blood pressure, who've seen their primary care provider at one of the nine participating sites in the past year. They must have hypertension noted in their medical records, be on medication for it, or have had three high blood pressure readings. It's not open to those with controlled blood pressure.

Inclusion Criteria

My blood pressure is higher than 140/90 mmHg and not controlled.
I am over 18 and have seen my primary care doctor at a participating site in the last year.
I have high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote blood pressure monitoring (RBPM) or RBPM + multilevel intensification intervention (MII) to improve hypertension control

54 months
Regular monitoring every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • RBPM
Trial Overview The study tests two interventions: Remote Blood Pressure Monitoring (RBPM) and Medication Intensification Intervention (MII), aiming to improve hypertension management through patient engagement and health system strategies within diverse populations in a safety-net setting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Remote Blood Pressure Monitoring (RBPM)Experimental Treatment1 Intervention
Group II: Multilevel Intensification interventions (MII)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials
410
Recruited
890,000+

NeighborHealth Center Internal Medicine at Gove Street (NH IM)

Collaborator

Boston Medical Center Family Medicine Primary Care (BMC FM)

Collaborator

NeighborHealth Center Family Medicine at Maverick Street (NH FM)

Collaborator

Mattapan Community Health Center (Mattapan)

Collaborator

Boston University School of Public Health (BUSPH)

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Manet Community Health Center (Maner CHC)

Collaborator

NeighborHealth South End (NH South End)

Collaborator

Boston Healthcare for the Homeless Program (BHCHP)

Collaborator

Citations

Multilevel Interventions Demonstrate Mixed Effectiveness for ...Conclusions: There was mixed evidence that multilevel interventions targeting cardiovascular health improved blood pressure among U.S.-based adults.
Multilevel Interventions Demonstrate Mixed Effectiveness for ...When studies reported multiple blood pressure outcomes, all eligible outcomes were extracted. Extracted effect measures in- cluded raw blood ...
Multilevel Solutions for Equitable Hypertension ControlA recent study in a safety-net county-based health system found that missed visits and treatment intensification accounted for 14% and 21% of ...
RBPM + MII for High Blood Pressure (BHEAT Trial)Trial Overview The study tests two interventions: Remote Blood Pressure Monitoring (RBPM) and Medication Intensification Intervention (MII), aiming to improve ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40565425/
Multilevel Interventions Demonstrate Mixed Effectiveness ...There was mixed evidence that multilevel interventions targeting cardiovascular health improved blood pressure among U.S.-based adults.
Integration of a multicomponent intervention for ...A greater percentage of participants achieved BP control at 24 months in the intervention (61.3%) arm versus usual care (51.2%) with associated odds ratio (95% ...
Hypertension Self-management in Socially Disadvantaged ...We studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans.
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