Supported HBPM Program for High Blood Pressure

(MonitorBP Trial)

Not currently recruiting at 1 trial location
ML
IK
Overseen ByIan Kronish, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
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 explores a new method for people to monitor and manage high blood pressure at home. It aims to determine if a supported home blood pressure monitoring (HBPM) program, combined with a strategy to encourage its use, can effectively assist patients with uncontrolled hypertension. Participants will either continue their usual care or access this new program. This trial suits adults with high blood pressure who have recently visited their primary care doctor. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could enhance home management of high blood pressure.

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 consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this supported HBPM program is safe for high blood pressure management?

Research shows that checking blood pressure at home is generally safe for managing high blood pressure. Studies have found that these programs help people better control their blood pressure and understand their condition.

A supported home blood pressure monitoring program, which includes helpful tips for effective use, has been tested in everyday settings. These studies found no major safety issues. Instead, they showed that the program improved blood pressure control and increased home monitoring.

Based on current research, the supported home blood pressure monitoring program is safe and well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Supported HBPM (Home Blood Pressure Monitoring) program because it offers a fresh take on managing high blood pressure. Unlike standard treatments that rely solely on medication and periodic doctor visits, this program empowers patients to monitor their blood pressure at home. It combines this self-monitoring with a multifaceted strategy aimed at boosting patient engagement and adherence. By enabling more consistent blood pressure tracking and active patient involvement, the program could lead to better control of hypertension and reduce the risk of related complications.

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

Research shows that checking blood pressure at home is crucial for managing high blood pressure. Studies have found that home blood pressure monitoring (HBPM) can predict heart and blood vessel problems. In this trial, participants in the intervention clinics will access a Supported HBPM program and a multifaceted implementation strategy to increase uptake among primary care patients with uncontrolled hypertension. This approach, which includes support and guidance, helps people control their blood pressure effectively. For instance, an online HBPM program improved blood pressure control before dialysis and helped patients learn more about their condition. Additionally, HBPM programs involving healthcare professionals, such as pharmacists, have successfully managed high blood pressure. Overall, using HBPM with support can simplify tracking and managing blood pressure at home.12367

Who Is on the Research Team?

IK

Ian Kronish, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with high blood pressure who are patients at certain New York medical practices, including those specializing in HIV medicine. They must have had a primary care visit within a specific timeframe and cannot participate if they have advanced dementia, frailty, pregnancy, stage 5 kidney disease, terminal illness or if their medical director opts out.

Inclusion Criteria

You must receive your primary care from specific healthcare networks in New York. This includes clinics that focus on HIV treatment.
At least one completed primary care office visit during relevant 6-month pre-implementation or post-implementation study time period
I have been diagnosed with high blood pressure.

Exclusion Criteria

My location is eligible for a home blood pressure monitoring program.
You have a very serious illness and are receiving end-of-life care.
My doctor has advised against joining this trial.
See 3 more

Timeline for a Trial Participant

Pre-Implementation

Data is retrospectively collected from a 12-month period before implementation to assess baseline outcomes

12 months

Implementation

Implementation of the Supported HBPM program across practices, with intervention clinics receiving access to the program and control clinics continuing usual care

12 months

Follow-up

Participants are monitored for changes in blood pressure and medication adherence after the implementation period

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Supported HBPM program plus multifaceted implementation strategy
  • Usual care
Trial Overview The study is testing whether a supported home blood pressure monitoring (HBPM) program combined with an implementation strategy can improve its adoption across diverse patient populations in multiple practices compared to usual care without the HBPM program.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Intervention Clinics, Pre-Implementation PeriodExperimental Treatment1 Intervention
Group II: Intervention Clinics, Post-Implementation PeriodExperimental Treatment1 Intervention
Group III: Control Clinics, Pre-Implementation PeriodExperimental Treatment1 Intervention
Group IV: Control Clinics, Post-Implementation PeriodExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

New York Presbyterian Hospital

Collaborator

Trials
77
Recruited
57,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

In a trial involving 62 older adults with hypertension, the MyBP digital tool showed high engagement rates (82.7%) for home blood pressure monitoring, indicating its feasibility for routine use.
While overall blood pressure reductions were similar between MyBP and control groups, those with higher initial systolic blood pressure in the MyBP group experienced greater declines, suggesting potential clinical benefits for specific patients.
Randomized feasibility trial of a digital intervention for hypertension self-management.Muldoon, MF., Einhorn, J., Yabes, JG., et al.[2023]
A review of 151 high blood pressure apps revealed that most only offer basic features like blood pressure monitoring, lifestyle advice, and information about hypertension, indicating a lack of comprehensive self-management support.
The presence of social support features was weakly correlated with download frequency, suggesting that users may value community engagement, while apps tailored for specific BP monitors received higher ratings, highlighting the importance of compatibility in user satisfaction.
Apps to Support Self-Management for People With Hypertension: Content Analysis.Hui, CY., Creamer, E., Pinnock, H., et al.[2020]
The program combining electronic home blood pressure monitoring and pharmacist-provided medication therapy management led to significant reductions in both systolic and diastolic blood pressure in 50 renal transplant recipients over one year, indicating improved blood pressure control (p < 0.05).
The involvement of a dedicated pharmacist in the renal transplant clinic helped identify and resolve medication-related issues in 46% of cases, enhancing medication adherence and overall patient care.
Achieving blood pressure control among renal transplant recipients by integrating electronic health technology and clinical pharmacy services.Migliozzi, DR., Zullo, AR., Collins, C., et al.[2019]

Citations

Home Blood Pressure Monitoring: Current Status and New ...The value of HBPM is highlighted by a growing body of evidence showing that home BP is an important predictor of target organ damage, and cardiovascular disease ...
Effectiveness of a nationwide community pharmacist-led ...Home blood pressure (BP) monitoring (HBPM) is fundamental to effective hypertension management. Incorporating community pharmacists into ...
Efficacy of a Web-Based Home Blood Pressure Monitoring ...This study aimed to explore the efficacy of a web-based home BP monitoring (HBPM) program in improving predialysis BP control and enhancing knowledge, ...
Trial Designs Implementing remote patient monitoring to ...The Monitor-BP Trial tests a scalable approach to implementing telemonitoring-enabled Supported HBPM interventions into real-world clinical settings.
Implementing a Home Blood Pressure Monitoring Program ...The Supported HBPM program consists of two options for obtaining electronic health record (EHR)-integrated home BP data. The low resource intensity option is ...
Supported HBPM Program for High Blood Pressure · Info ...The research suggests that home blood pressure monitoring (HBPM) is generally safe for managing high blood pressure. It helps patients engage in healthy ...
Remote Cardiovascular Hypertension Program Enhanced ...A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring.
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