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

Trial Summary

What is the purpose of this trial?

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care. The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians. Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

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 data supports the effectiveness of home blood pressure monitoring as a treatment for high blood pressure?

Home blood pressure monitoring (HBPM) is recommended because it provides more accurate and consistent readings than those taken in a doctor's office, helping to better predict cardiovascular risk. It also helps patients adhere to their treatment plans and can distinguish between different types of hypertension, improving overall blood pressure management. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring is generally considered safe for humans, as it is a non-invasive method that helps manage high blood pressure by providing more data points for diagnosis and treatment. ^{5 6 7 8 9}

How is the Team-Based Home Blood Pressure Monitoring treatment different from other treatments for high blood pressure?

Team-Based Home Blood Pressure Monitoring is unique because it combines home blood pressure monitoring with a collaborative approach involving healthcare professionals like nurses, pharmacists, and doctors. This team-based care model aims to improve blood pressure control by providing more personalized and coordinated care compared to traditional methods. ^{3 4 5 9 10}

Research Team

Kevin Fiscella, MD, MPH

Principal Investigator

URMC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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 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 (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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. [2018]

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

Relative utility of home, ambulatory, and office blood pressures in the prediction of end-organ damage. [2018]

3. United States 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. [2010]

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

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Italy pubmed.ncbi.nlm.nih.gov

[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparisons of home and daytime ambulatory blood pressure measurements. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The optimal night-time home blood pressure monitoring schedule: agreement with ambulatory blood pressure and association with organ damage. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Awareness and recommendation of home blood pressure measurement among physicians in India: Results from Asia HBPM survey 2020. [2023]