Supported HBPM Program for High Blood Pressure

(MonitorBP Trial)

Recruiting at 1 trial location

Overseen By Ian Kronish, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Advanced dementia, Pregnancy, End-stage kidney disease, Terminal illness

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

Compensation: Varies

Number of Visits: Unknown

23928 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 consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the Supported HBPM program for high blood pressure?

Research shows that home blood pressure monitoring (HBPM) is effective in managing high blood pressure, especially when combined with structured education and support. Studies indicate that HBPM, along with physician recommendations, can lead to better blood pressure control and medication adherence. ^{1 2 3 4 5}

Is home blood pressure monitoring (HBPM) safe for managing high blood pressure?

The research suggests that home blood pressure monitoring (HBPM) is generally safe for managing high blood pressure. It helps patients engage in healthy behaviors and manage their condition effectively, with no specific safety concerns reported in the studies. ^{4 6 7 8 9}

How is the Supported HBPM program for high blood pressure different from other treatments?

The Supported HBPM program is unique because it combines home blood pressure monitoring with a multifaceted strategy, potentially including mobile apps and pharmacist support, to improve blood pressure control and medication adherence. This approach is more comprehensive than traditional methods, which may not integrate technology and personalized support. ^{4 10 11 12 13}

What is the purpose of this trial?

This trial aims to see if a supported home blood pressure monitoring program can help patients with uncontrolled hypertension manage their condition better. The program provides tools and support for patients to measure their blood pressure at home and share the results with their doctors. The goal is to improve blood pressure control by making it easier for doctors to monitor and adjust treatments. Home blood pressure monitoring is a self-monitoring tool recommended by major guidelines and supported by evidence for its benefits in improving blood pressure control.

Research Team

Ian Kronish, MD

Principal Investigator

Columbia University

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Intervention Clinics, Pre-Implementation Period Experimental Treatment 1 Intervention

Usual care

Group II: Intervention Clinics, Post-Implementation Period Experimental Treatment 1 Intervention

Access to Supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension

Group III: Control Clinics, Pre-Implementation Period Experimental Treatment 1 Intervention

Usual care

Group IV: Control Clinics, Post-Implementation Period Experimental Treatment 1 Intervention

Usual care

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+

Findings from Research

In a study of 6,320 adults with hypertension, those who received a physician's recommendation for home blood pressure monitoring (HBPM) had significantly lower blood pressure, averaging 3.1/4.5 mm Hg lower than those without such recommendations.

Patients who used HBPM after receiving a physician's recommendation were nearly three times more likely to adhere to their hypertension medication, highlighting the importance of physician involvement in encouraging HBPM for better blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. Tang, O., Foti, K., Miller, ER., et al.[2021]

The Hypertension Disease Management Program (HDMP) significantly reduced systolic and diastolic blood pressure in participants, with systolic pressure decreasing from 137.5 mm Hg to 131.2 mm Hg and diastolic pressure from 86.0 mm Hg to 83.8 mm Hg, indicating its efficacy in managing hypertension.

Participants in the HDMP showed improved health behaviors, such as better dietary choices and regular blood pressure monitoring, but there was no significant change in medical service usage or costs compared to the control group, suggesting that while HDMP enhances lifestyle, its impact on healthcare utilization remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the hypertension disease management program in Korea. Kim, Y., Lee, K., Shin, E., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps to Support Self-Management for People With Hypertension: Content Analysis. Hui, CY., Creamer, E., Pinnock, H., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of a digital intervention for hypertension self-management. Muldoon, MF., Einhorn, J., Yabes, JG., et al.[2023]

The MyBP program, which uses automated SMS for home blood pressure monitoring, significantly enhances patients' understanding of hypertension and encourages behavior changes through educational videos and consistent monitoring.

Patients reported that receiving regular blood pressure readings motivated them to take action, demonstrating that this program effectively supports self-management of hypertension by leveraging feedback and increasing awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMS-facilitated home blood pressure monitoring: A qualitative analysis of resultant health behavior change. Allen, ME., Irizarry, T., Einhorn, J., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 452 hypertensive patients in Turkey revealed that most patients chose their home sphygmomanometers based on simplicity and ease of use, rather than on their accuracy or validation status.

None of the patients were aware of whether their home sphygmomanometers were validated or calibrated, indicating a significant gap in knowledge that could lead to inaccurate blood pressure readings and potential mismanagement of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? Bardak, S., Turgutalp, K., Özcan, T., et al.[2015]

In a study of 213 adults with hypertension over 3 months, home blood pressure monitoring (HBPM) combined with a health education session did not significantly reduce blood pressure or improve medication adherence compared to usual care.

While the HBPM group showed some reduction in blood pressure, it was not greater than the control group, suggesting that more effective educational interventions and sharing blood pressure data might enhance outcomes in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. Cuffee, YL., Sciamanna, C., Gerin, W., et al.[2022]

References

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

Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Evaluation of the hypertension disease management program in Korea. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring--a trial on the effect of a structured education program. [2013]

4. Canada pubmed.ncbi.nlm.nih.gov

Apps to Support Self-Management for People With Hypertension: Content Analysis. [2020]

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

Evaluation of a nurse-based hypertension management program: screening, management, and outcomes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of a digital intervention for hypertension self-management. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

SMS-facilitated home blood pressure monitoring: A qualitative analysis of resultant health behavior change. [2020]

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

Implementing Home Blood Pressure Monitoring into Clinical Practice. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Home blood pressure for the management of hypertension: will it become the new standard of practice? [2011]

10. England pubmed.ncbi.nlm.nih.gov

Achieving blood pressure control among renal transplant recipients by integrating electronic health technology and clinical pharmacy services. [2019]

11. England pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? [2015]

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

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Pilot Results of a Digital Hypertension Self-management Program Among Adults With Excess Body Weight: Single-Arm Nonrandomized Trial. [2022]