Home Blood Pressure Monitoring for High Blood Pressure Control in Stroke Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Enrolled in other study, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

50 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 seems focused on monitoring blood pressure at home, so you may not need to change your medication routine.

What data supports the effectiveness of the treatment using Omron Home Blood Pressure Cuff and Monitor for high blood pressure control in stroke patients?

Research shows that home blood pressure monitoring with devices like the Omron can improve blood pressure control by increasing patient awareness and compliance. Telemonitoring, which involves sending readings to healthcare providers, has been shown to enhance treatment effectiveness and medication adherence. ^{1 2 3 4 5}

Is home blood pressure monitoring with Omron devices safe for humans?

Home blood pressure monitors, like those from Omron, have been validated for accuracy and are generally considered safe for use in humans. These devices are designed to help people measure their blood pressure at home, which can be valuable for managing conditions like high blood pressure. ^{1 2 3 5 6}

How is the Omron Home Blood Pressure Monitor treatment different from other treatments for high blood pressure in stroke patients?

The Omron Home Blood Pressure Monitor is unique because it allows patients to measure their blood pressure at home, providing a digital platform that tracks data, sends reminders, and shares information with doctors, which can improve patient compliance and care. ^{1 2 3 5 7}

What is the purpose of this trial?

The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients. The main question\[s\] it aims to answer are: 1. Does providing a free home blood pressure cuff improve control of hypertension? 2. Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations? 3. Does improved control of home blood pressure decrease adverse patient outcomes? Participants will be asked to * Take their blood pressure at home and records the results * Participate in follow-up phone calls from investigators at at 3 and 6 months Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education

Research Team

Liron D Kraler, MD

Principal Investigator

Stanford University

Christina M Mijalski Sells, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 who've been treated at Stanford Hospital's stroke service and are going home or to acute rehab. They must have had a stroke, mini-stroke, or be at risk of stroke with high blood pressure but don't own a blood pressure cuff. They can't join if they're in another similar study or have an upper arm larger than 20 inches.

Inclusion Criteria

I, or my legal representative, agree to participate and can give consent.

I or someone I trust can use a home blood pressure monitor on me.

I have been diagnosed with high blood pressure.

Exclusion Criteria

My upper arm is larger than 20 inches in circumference.

Any other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study

Currently enrolled in another blood pressure or secondary prevention interventional research study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive education on blood pressure monitoring and are provided with a home blood pressure cuff if in the intervention group

6 months

Initial in-person visit, followed by phone calls at 3 and 6 months

Follow-up

Participants are monitored for blood pressure control and adverse outcomes through phone calls and chart reviews

6 months

Phone calls at 3 and 6 months

Treatment Details

Interventions

• Use of Omron Home Blood Pressure Cuff

Trial Overview The study tests if giving patients a free home blood pressure monitor and teaching them how to use it helps control high blood pressure better than just routine education. It also checks if this approach works well for disadvantaged groups and reduces negative health outcomes.

Participant Groups

Group I: Access to Blood Pressure Monitoring Experimental Treatment 1 Intervention

Participants will also receive the teaching administered to the control group. In addition, they will be given an Omron Home Blood Pressure Cuff furnished by the study. The nurse will provide additional education on on how to use the cuff, and how to record values in a blood pressure log.

Group II: Standard of Care Active Control 1 Intervention

Participants will receive routine stroke discharge education which is standard of care. A stroke nurse will provide and review with the patient a short informational pamphlet on the importance of blood pressure monitoring.

Use of Omron Home Blood Pressure Cuff is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Omron Home Blood Pressure Monitor for:

• Hypertension management
• Stroke prevention

Approved in United States as Omron Home Blood Pressure Monitor for:

• Hypertension management
• Stroke prevention

Approved in Canada as Omron Home Blood Pressure Monitor for:

• Hypertension management
• Stroke prevention

Approved in Japan as Omron Home Blood Pressure Monitor for:

• Hypertension management
• Stroke prevention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The OMRON Hypertension Management Platform improved blood pressure control among hypertensive patients, indicating its effectiveness as a home monitoring tool.

However, the use of this digital platform was associated with an increase in the number and cost of hypertension-related claims, suggesting that while it may enhance patient management, it could also lead to higher healthcare costs in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital hypertension management: clinical and cost outcomes of a pilot implementation of the OMRON hypertension management platform. Holmstrand, EC., Sato, H., Li, J., et al.[2023]

The study involving 503 patients with essential hypertension demonstrated that home blood pressure (BP) measurements using the OMRON HEM 706 device showed significant decreases in both systolic and diastolic BP during treatment with perindopril, indicating effective management of hypertension.

Home BP monitoring revealed a notable incidence of 'white coat hypertension' (9.4% of patients) and 'white coat normotension' (26.3% of patients), highlighting its importance in identifying patients who may be over- or under-treated based on casual BP readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of home pressure monitoring in the treatment hypertension in the practice of general medicine]. Widimský, J., Balazovjech, I., Lánská, V.[2013]

The Omron HEM-1020 and Omron i-Q132 blood pressure devices were validated by trained doctors and found to provide accurate readings, with differences from a standard mercury sphygmomanometer within the acceptable range of ± 3 mmHg.

Both devices meet the European Society of Hypertension guidelines, making them reliable options for patients to measure their blood pressure at home, which can enhance self-monitoring and management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of home blood pressure-monitoring devices, Omron HEM-1020 and Omron i-Q132 (HEM-1010-E), according to the European Society of Hypertension International Protocol. Takahashi, H., Yoshika, M., Yokoi, T.[2019]

Home blood pressure (BP) telemonitoring significantly enhances patient awareness and management of hypertension, leading to improved BP control rates, especially when combined with self-adjustment based on treatment algorithms.

Telemonitoring that includes active intervention from healthcare professionals not only boosts medication compliance but also increases the likelihood of achieving target BP levels, making it a valuable tool alongside traditional doctor-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. Lee, CJ., Park, S.[2022]

The Omron HEM-7320-LA blood pressure monitor with Intelli Wrap technology was tested on 39 participants and met the accuracy criteria set by the European Society of Hypertension, indicating it is a reliable device for measuring blood pressure.

While the device slightly overestimated systolic and diastolic blood pressure by 0.6 mmHg and 2.2 mmHg respectively, it effectively accommodates a wide range of arm sizes, making it suitable for self-measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population. Grover-Páez, F., Cardona-Muñoz, EG., Cardona-Müller, D., et al.[2019]

The Omron Elite 7300W home blood pressure monitor was tested for accuracy using the European Society of Hypertension (ESH) protocol, showing an average error of 1.2 mmHg, which indicates good accuracy for measuring blood pressure.

This device is validated for use in both women and men, making it a reliable option for home monitoring of blood pressure, although individual validation and periodic accuracy checks are still recommended for each user.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men. Grim, CE., Grim, CM.[2019]

In a study of 39 elderly stroke patients, 90% of their home blood pressure recordings matched the readings from a BP monitor, indicating high reliability in self-monitoring.

The small discrepancies found in the home recordings (average differences of 0.6 mmHg systolic and 0.3 mmHg diastolic) are unlikely to impact clinical management, suggesting that home BP monitoring could be a valuable tool for guiding treatment decisions in hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are stroke patients' reports of home blood pressure readings reliable? Cross-sectional study. Shaw, J., Kerry, S., Adjei-Gyamfi, Y., et al.[2016]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Digital hypertension management: clinical and cost outcomes of a pilot implementation of the OMRON hypertension management platform. [2023]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[The role of home pressure monitoring in the treatment hypertension in the practice of general medicine]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Validation of home blood pressure-monitoring devices, Omron HEM-1020 and Omron i-Q132 (HEM-1010-E), according to the European Society of Hypertension International Protocol. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. [2022]

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

Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population. [2019]

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

The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men. [2019]

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

Are stroke patients' reports of home blood pressure readings reliable? Cross-sectional study. [2016]