Purpose

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. We 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Home Blood Pressure Self Management
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)
    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.
    Other names:
    • Medication Self-Titration
Active Comparator
Usual Care
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
    Participant will follow up as would normally do with primary care provider for blood pressure management.

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Mary Carter Denny
202-444-8532
MaryCarter.Denny@medstar.net

More Details

Status
Recruiting
Sponsor
MedStar Georgetown University Hospital

Study Contact

Mary Carter Denny, MD
202-444-8532
MaryCarter.Denny@medstar.net

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. We 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.