Clinical trial NCT04226157: Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*
Official title: Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Hypertension
Keywords: Blood Pressure
Stroke
Hypertension
Blood Pressure Monitor
Home Blood Pressure Monitor
Ischemic Stroke
Stroke Prevention
Lead sponsor: MedStar Georgetown University Hospital
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
First posted: 2020-01-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of blood pressure self management in stroke survivors
timeFrame: Three Months
Secondary outcomes:
measure: Systolic Blood Pressure Difference
timeFrame: three months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
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