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Clinical Trials/NCT04226157
NCT04226157
Unknown
N/A

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

MedStar Georgetown University Hospital1 site in 1 country32 target enrollmentFebruary 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
MedStar Georgetown University Hospital
Enrollment
32
Locations
1
Primary Endpoint
Feasibility of blood pressure self management in stroke survivors
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2019
End Date
March 31, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
MedStar Georgetown University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Mary Carter Denny

Assistant Professor of Neurology

MedStar Georgetown University Hospital

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

Outcomes

Primary Outcomes

Feasibility of blood pressure self management in stroke survivors

Time Frame: Three Months

At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention.

Secondary Outcomes

  • Systolic Blood Pressure Difference(three months)

Study Sites (1)

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