Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*

Study Overview
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Brief Summary
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The purpose of this pilot study is to assess the feasibility of implementing a home blood pressure self-management program in a population of recent stroke survivors in the Washington, D.C. area. The investigators hypothesize that hypertensive stroke survivors in the Washington, DC area who participate in the Home Blood Pressure Monitoring program will have a greater reduction in mean systolic blood pressure (SBP) from baseline to 3 months, as measured by automated office blood pressure (AOBP), as compared to usual care.

Detailed Description
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The purpose of this trial is to determine if a home blood pressure self-management (HBPS) program, including home monitoring and medication adjustments, is practical to use in recent stroke survivors and whether or not it is associated with lowering blood pressure after 3 months. Data from this trial may be used to do more research and may be used by doctors when seeing patients.This research is being done because high blood pressure, also called hypertension, is the leading risk factor for stroke. Lowering blood pressure (BP) has been shown to lower the risk of future strokes. The majority of stroke survivors continue to have uncontrolled BP. Currently, blood pressure (BP) is most often measured in the doctor's office. However, those single BP measurements are not the best picture of blood pressure over time and can be influenced by the stress of being in a doctor's office, known as the white coat effect. This is why measuring BP at home may paint a more accurate picture of a patient's true long-term BP. Home blood pressure monitoring (HBPM) is recommended in the recently updated national hypertension guidelines. Home BP monitoring plus guided BP medication self-adjustments is associated with lower BP in patients with high blood pressure. The investigators believe that a HBPS program, including medication self-adjustment and home monitoring, may help to reduce blood pressure in patients with hypertension within 3 months.

Official Title
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Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study

Conditions
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Ischemic Stroke, Hypertension

Intervention / Treatment
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* Device: Home Blood Pressure Monitoring Device (Qardio Arm)
* Other: Primary Care Provider Blood Pressure Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke in the past 180 days of screening Age >/= 18 years old Automated Office Blood Pressure ≥135 systolic or ≥85 diastolic at time of screening Stage 2 hypertension (as defined by >140 mmHg SBP and or >90 mmHg DBP on 2 occasions or history of hypertension prior to stroke or currently taking antihypertensive medications) Able to live independently (as defined by modified Rankin scale score of 0-2) Exclusion Criteria: CKD stage IV or greater (GFR < 30) Inability to check BP in either arm (e.g. amputation, lymphedema) Pregnancy High-grade intracranial or extracranial stenosis requiring a higher BP goal Unable to provide informed consent for themselves in English or Spanish Life expectancy less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with hypertension who have had a stroke within the past 6 months will be randomized into two groups in a one to one ratio: Home Blood Pressure Self-Management (HBPS) or Usual Care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Blood Pressure Self Management<br>The HBPS group will check their blood pressure at home daily using a smart BP cuff with telemonitoring capability (Home Qardio) and guided to use a self-titration plan between office visits for persistently elevate blood pressures. | Device: Home Blood Pressure Monitoring Device (Qardio Arm)<br>* The Home Blood Pressure Device with telemonitoring capability will allow the participants and physician to monitor blood pressure over time and titrate blood pressure medications as needed for persistently elevated blood pressure.<br>* Other names: Medication Self-Titration;|
| Active Comparator: Usual Care<br>The Usual Care group will have their blood pressure monitored and medications adjusted by their primary care provider. | Other: Primary Care Provider Blood Pressure Management<br>* Participant will follow up as would normally do with primary care provider for blood pressure management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of blood pressure self management in stroke survivors | At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention. | Three Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure Difference | Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Stroke, Hypertension, Blood Pressure Monitor, Home Blood Pressure Monitor, Ischemic Stroke, Stroke Prevention