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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether providing stroke patients with a free home blood pressure cuff (Omron Home Blood Pressure Monitor) can help them manage high blood pressure (hypertension) and improve their health. The trial aims to determine if using the device leads to better outcomes, particularly for less advantaged individuals. Participants will either receive standard education or a blood pressure monitor with additional guidance on its use. Ideal candidates are stroke patients with high blood pressure who lack a home monitor and can measure their blood pressure at home. As an unphased trial, this study offers patients the chance to contribute to valuable research that could enhance health management for stroke survivors.

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 prior data suggests that the use of the Omron Home Blood Pressure Cuff is safe for stroke patients?

Research shows that using an Omron Home Blood Pressure Cuff is generally safe for checking blood pressure at home. One study found that 80% of users managed their blood pressure, and 55% reached normal levels after one year. This indicates the device is effective and easy to use over time.

Regularly checking blood pressure at home can also lower the risk of serious heart and brain problems. The Omron device includes smart features that detect issues like atrial fibrillation (AFib), which is important for preventing strokes. While the device does not treat high blood pressure, it provides important information to help manage it better.

Overall, research supports that the Omron Home Blood Pressure Cuff helps many people control their blood pressure without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using home blood pressure monitoring for stroke patients because it empowers individuals to take an active role in managing their health. Unlike conventional treatments that often involve frequent doctor visits for blood pressure checks, this approach allows patients to monitor their blood pressure conveniently at home using an Omron Home Blood Pressure Cuff. This not only promotes consistent monitoring but also helps patients and healthcare providers track progress more effectively, potentially leading to better blood pressure control and reduced risk of future strokes. By making blood pressure monitoring more accessible and patient-driven, this method could revolutionize how we manage high blood pressure in stroke patients.

What evidence suggests that using a home blood pressure cuff is effective for controlling high blood pressure in stroke patients?

This trial will compare standard stroke discharge education with the addition of home blood pressure monitoring. Studies have shown that a home blood pressure cuff can help people manage their blood pressure more effectively. Participants in the "Access to Blood Pressure Monitoring" arm will receive an Omron Home Blood Pressure Cuff, enabling regular blood pressure checks and potentially aiding in high blood pressure control. Research indicates that regular monitoring with these devices can lower stroke risk by improving blood pressure management. Additionally, the Omron device can detect atrial fibrillation (AFib), a heart condition that increases stroke risk. These benefits suggest that a home blood pressure monitor could be especially helpful for stroke patients in managing their condition. ^{4 6 7 8 9}

Who Is on the Research Team?

Liron D Kraler, MD

Principal Investigator

Stanford University

Christina M Mijalski Sells, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4150505/

A Blood Pressure Monitoring Method for Stroke Management This study proposed a new blood pressure estimation method based on the pulse transit time to realize continuous monitoring.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05730465?tab=history&a=1

Record History | ver. 1: 2023-02-14 | NCT05730465 Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor ... Use of an Omron Home Blood Pressure Cuff to monitor ...

3. healthcare.omron.com healthcare.omron.com/healthcare-solutions/cardiovascular-health/intellisense-afib

Reduce stroke risk by 66% with early detection of AFib 1 OMRON's AI-powered technology calculates blood pressure values and detects AFib using a pulse pressure wave (PPW).

4. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/i/NCT05730465.html

Improving Blood Pressure Control in Stroke Patients by ... 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 ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819402

Remote Blood Pressure Monitoring With Social Support for ... Main Outcomes and Measures The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes ...

6. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/12/2/e002067

Community stroke team use of home blood pressure ... A 5 mm Hg systolic BP (SBP) reduction reduces the risk of serious cardiovascular events by approximately 10%.5 The Greater Manchester ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3162184/

Stroke patients' perceptions of home blood pressure ... This study describes the experiences of home monitoring among stroke patients with hypertension recruited from hospital stroke clinics. Participants had been ...

8. omronhealthcare-ap.com omronhealthcare-ap.com/au/events/detail/173

OMRON's Latest Data Review Shows the Efficacy of Home ... The study also shows that 80% of this group of users were able to control their blood pressure, with 55% achieving normal SBP by the 12th month ...

9. prnewswire.com prnewswire.com/news-releases/omron-healthcare-issues-national-call-to-action-on-routine-at-home-blood-pressure-monitoring-in-response-to-new-guidelines-302533998.html

OMRON Healthcare Issues National Call-to-Action on ... "Routine at-home monitoring with tools like the OMRON 10 Series with AI-powered AFib detection can help identify these heart-brain health risks ...