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

Not Applicable

• Conditions: Ischemic Stroke; Hypertension
• Interventions: Device: Home Blood Pressure Monitoring Device (Qardio Arm); Other: Primary Care Provider Blood Pressure Management

• Registration Number: NCT04226157
• Lead Sponsor: MedStar Georgetown University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Blood Pressure Self Management	Home Blood Pressure Monitoring Device (Qardio Arm)	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.
Usual Care	Primary Care Provider Blood Pressure Management	The Usual Care group will have their blood pressure monitored and medications adjusted by their primary care provider.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure Difference	three months	Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.

Trial Locations

Locations (1)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States