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

Recruiting in Palo Alto (17 mi)

Overseen by Liron D Kraler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Enrolled in other study, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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

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.

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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.

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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.

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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 am over 18, was treated for a stroke at Stanford Hospital, and am going home or to acute rehab.

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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Hospital Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University Lead Sponsor

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] Home monitoring of blood pressure (BP) in hypertensive patients can improve outcomes, but challenges to both patient compliance and the effective transmission of home BP readings to physicians can limit the extent to which physicians can use this information to improve care. The OMRON Hypertension Management Platform (OMRON HMP) pairs a home BP cuff with a digital product that tracks data, provides reminders to improve patient compliance, and provides a streamlined source of information to physicians.

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] The aim of the study was to evaluate home blood pressure (BP) measurement using an OMRON HEM 706 device (including printout values) for the treatment of essential hypertension by a greater number of general practitioners and to establish the incidence of "white coat hypertension".

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] Allowing patients to measure their blood pressure (BP) at home is recognized as being of clinical value. However, it is not known whether BP measurement is usually taken correctly outside of a clinical setting. Automated proper wrapping of the cuff and correction of wrong posture will help in taking BP measurement properly. This study aimed to evaluate the performance of the Omron HEM-1020 and the Omron i-Q132 devices, which are equipped with those functions.

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

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. [2022] Despite improvements in hypertension awareness and treatment, the blood pressure (BP) control rate still remains at around 50%. One of the major determinants of low BP control results from therapeutic inertia of the physician and suboptimal compliance of the patients. Home BP self-measurement and monitoring improves patients' awareness and helps the management of hypertension. Recent technological advances are allowing for accurate measurement and telemonitoring of home BP, with a number of randomized clinical trials demonstrating the efficacy of telemonitoring for BP control. Home BP telemonitoring combined with self-adjustment based on prespecified treatment algorithms has been shown to improve BP control. Additionally, telemonitoring with active intervention by medical professionals has been shown to improve drug compliance and increase the target BP achievement rate. Although nothing can replace the tried and tested doctor-patient relationship in the office, telemonitoring of home BP will be an important tool for treating hypertension in the future.

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] The aim of this study was to determine the accuracy of the Omron HEM-7320-LA with Intelli Wrap technology cuff HEM-FL1 for self-measurement and clinic blood pressure (BP) measurement according to the European Society of Hypertension International Protocol revision 2010.

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] To test the accuracy of the Omron Elite 7300W home blood pressure monitor using the European Society of Hypertension (ESH) Protocol.

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

Are stroke patients' reports of home blood pressure readings reliable? Cross-sectional study. [2016] Home blood pressure (BP) monitoring is gaining increasing popularity among patients and may be useful in hypertension management. Little is known about the reliability of stroke patients' records of home BP monitoring.