Home Blood Pressure Monitoring for High Blood Pressure

(TB-HBPM Trial)

Overseen By Kevin Fiscella

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Dementia, End-stage renal disease, Hospice, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5760 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based program designed to help people manage high blood pressure by sending their readings directly to their healthcare team. The program includes education on measuring blood pressure, setting goals, managing treatment and lifestyle changes, and team training for better care coordination. The study examines how well this program, called Team-Based Home Blood Pressure Monitoring, can improve blood pressure control and address racial disparities in care. Suitable participants are current patients diagnosed with high blood pressure who have visited a participating practice at least once since July 2021. As an unphased study, this trial offers a unique opportunity to contribute to innovative solutions for managing high blood pressure at home.

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 seems focused on monitoring blood pressure at home rather than changing existing treatments.

What prior data suggests that this team-based home blood pressure monitoring is safe?

Research shows that team-based home blood pressure monitoring (TB-HBPM) is generally easy for people to use. Studies have found that a team, including a clinical pharmacist, helps people better control their blood pressure. This method involves more than just checking blood pressure at home; it also includes education and support from healthcare providers.

No serious safety problems have been reported with TB-HBPM. The goal is to help patients manage their high blood pressure more effectively. This involves measuring blood pressure correctly, setting target goals, and making necessary lifestyle and medication changes.

Regular communication with healthcare teams allows for quick resolution of any minor issues. Overall, evidence suggests that TB-HBPM is a safe and effective way to manage high blood pressure from home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about team-based home blood pressure monitoring (TB-HBPM) because it offers a fresh approach to managing high blood pressure compared to traditional in-office visits and medication adjustments. With TB-HBPM, patients can track their blood pressure in their own homes, providing more accurate and consistent data over time. This method empowers patients, encourages engagement in their own health, and allows healthcare teams to tailor interventions based on real-world data. By integrating a team-based approach, there's potential for improved communication and more personalized treatment plans, which could lead to better blood pressure control and reduced risk of complications.

What evidence suggests that Team-Based Home Blood Pressure Monitoring is effective for hypertension?

Research shows that team-based home blood pressure monitoring (TB-HBPM), studied in this trial, helps control high blood pressure. Studies have found that when patients share home blood pressure readings with their healthcare team, they manage their condition better. By involving pharmacists and doctors, this team approach offers more support and empowers patients to take charge of their health. Evidence suggests these methods achieve better results than traditional care. This team-based approach holds particular promise for improving blood pressure control among different racial groups. ^{1 2 4 6 7}

Who Is on the Research Team?

Kevin Fiscella, MD, MPH

Principal Investigator

URMC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with high blood pressure who are patients at participating practices. It includes practice employees involved in hypertensive patient care. People with dementia, end-stage renal disease, hospice care, or current pregnancy cannot join.

Inclusion Criteria

I am between 18 and 85 years old with high blood pressure.

You have been diagnosed with high blood pressure using specific medical codes.

I was diagnosed with high blood pressure and saw a doctor for it by July 1, 2021.

Exclusion Criteria

I have been diagnosed with dementia, end-stage renal disease, or am in hospice care.

Currently pregnant

Not current patient in the participating practices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year

12 months

Intervention Implementation

Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later

18 months

Post-intervention

Post implementation phase of the suites 2 years after introduction of intervention

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

• At home Blood Pressure Monitoring Cuff
• Team-Based Home Blood Pressure Monitoring

Trial Overview The study tests a team-based home blood pressure monitoring program that lets patients send their readings to their health teams and receive coordinated hypertension care including education and monthly feedback.

How Is the Trial Designed?

Group I: Suite TB-HBPM throughout intervention implementation Experimental Treatment 1 Intervention

Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.

Group II: Suite TB-HBPM pre intervention Experimental Treatment 1 Intervention

Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.

Group III: Suite TB-HBPM post intervention implementation Experimental Treatment 1 Intervention

Post implementation phase of the suites 2 years after introduction of intervention.

Team-Based Home Blood Pressure Monitoring is already approved in United States, European Union for the following indications:

Approved in United States as Home Blood Pressure Monitoring for:

• Hypertension management
• Blood pressure control

Approved in European Union as Home Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The TBC-HTA study is evaluating a team-based care intervention involving nurses, pharmacists, and physicians to improve blood pressure control in 110 hypertensive outpatients over a 6-month period, compared to usual care.

The primary goal is to assess the difference in daytime ambulatory blood pressure between the team-based care group and the usual care group, with secondary outcomes including patient and healthcare professional satisfaction and long-term blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. Santschi, V., Wuerzner, G., Chiolero, A., et al.[2018]

A study of 94 untreated hypertensive adults found that averaging night-time home blood pressure (HBP) readings improves the correlation with night-time ambulatory blood pressure (ABP) and preclinical target-organ damage, with optimal results achieved by averaging four to six readings.

A two-night schedule of HBP monitoring, consisting of six readings, is recommended as the minimum requirement for reliable assessment, providing good agreement with ABP and better association with indicators of organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The optimal night-time home blood pressure monitoring schedule: agreement with ambulatory blood pressure and association with organ damage. Kollias, A., Andreadis, E., Agaliotis, G., et al.[2023]

In a study involving 100 Alaska Native and American Indian participants with hypertension, the majority (66%) preferred wrist blood pressure monitoring devices over arm devices due to higher ratings in ease of use and comfort.

Despite valuing accuracy in home blood pressure monitoring, participants prioritized usability factors like comfort and ease of use when choosing a device, indicating that these characteristics are crucial for long-term management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. Railey, AF., Dillard, DA., Fyfe-Johnson, A., et al.[2023]

In a study of 366 volunteers, the first reading of home blood pressure measurements (HBPM) was generally higher than subsequent readings, indicating that multiple measurements can improve accuracy in assessing blood pressure.

Ambulatory blood pressure measurements (ABPM) showed a wider range and tended to be higher than corresponding HBPMs, suggesting that ABPM may provide a more comprehensive view of a person's blood pressure throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of home and daytime ambulatory blood pressure measurements. Chrubasik-Hausmann, S., Chrubasik, C., Walz, B., et al.[2021]

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]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with known or suspected hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can also aid in distinguishing between white-coat and sustained hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: executive summary a joint scientific statement from the american heart association, american society of hypertension, and preventive cardiovascular nurses association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2010]

A survey of 832 physicians in India revealed that while 88% recommend home blood pressure monitoring (HBPM) to their patients, only about 35% of patients actually own a device and only 30% measure their blood pressure at home.

Many physicians provide insufficient instructions regarding HBPM, with only 31.3% advising patients to measure their blood pressure before taking antihypertensive medications, indicating a need for better education and alignment with hypertension guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and recommendation of home blood pressure measurement among physicians in India: Results from Asia HBPM survey 2020. Wander, GS., Salman, E., Matsushita, N., et al.[2023]

Home blood pressure (HBP) monitoring over a 10-week period is a strong independent predictor of left-ventricular mass index (LVMI), which is an indicator of cardiovascular end-organ damage, compared to office blood pressure (OBP) and ambulatory blood pressure (ABP).

The effectiveness of HBP in predicting cardiovascular damage is significant only when a sufficient number of readings are taken; using just the first 12 readings diminishes its predictive power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative utility of home, ambulatory, and office blood pressures in the prediction of end-organ damage. Shimbo, D., Pickering, TG., Spruill, TM., et al.[2018]

Home blood pressure monitoring (HmBPM) leads to a moderate but statistically significant reduction in both systolic and diastolic blood pressure compared to ambulatory and hospital monitoring, with reductions ranging from -2.50 mmHg to -4.25 mmHg for systolic and -1.45 mmHg to -2.37 mmHg for diastolic pressure.

The effectiveness of HmBPM in managing hypertension is influenced by the patient's ability to accurately perform and interpret the measurements, as well as how healthcare professionals utilize this data to adjust treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] Re, LG., Fusetti, V.[2022]

In a 3-month randomized controlled trial involving 375 participants, both telemonitoring of home blood pressure measurements (TBPM) and conventional monitoring led to significant reductions in daytime ambulatory blood pressure, with no significant difference in outcomes between the two methods.

Despite both groups achieving similar blood pressure reductions, further education for general practitioners may be necessary to enhance hypertension management and control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. Hoffmann-Petersen, N., Lauritzen, T., Bech, JN., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10725081/

TEAM-BASED HOME BLOOD PRESSURE MONITORING ... Home Blood Pressure Monitoring (HBPM) that includes a team with a clinical pharmacist is an evidence-based intervention that improves blood pressure (BP).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002550

Team-based home blood pressure monitoring for ... Our objective is to identify and rigorously evaluate strategies for implementing and sustaining TB-HBPM within primary care. Our aims are as follows. Aim 1: ...

3. nature.com nature.com/articles/s41440-025-02422-6

Effectiveness of a nationwide community pharmacist-led ... Ideal remote hypertension management requires HBPM, data integration by technology, and team management with pharmacists and physicians.

4. cdc.gov cdc.gov/high-blood-pressure/php/data-research/team-based-care/index.html

Team-Based Care to Improve Blood Pressure Control Team members can support and empower patients to take an active role in controlling their high blood pressure. Strategies include health behavior counseling, ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1028642

Effectiveness of Home Blood Pressure Monitoring, Web ... The e-BP study was a 3-group randomized controlled trial designed to compare 2 interventions to improve hypertension control. Patients who had ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37722482/

Team-based home blood pressure monitoring for ... - PubMed We developed potentially feasible and sustainable implementation strategies to improve hypertension control and BP equity.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05885997

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 ...