Recruiting

Observational Study

Sponsor:

MedStar Georgetown University Hospital

Code:

NCT04226157

Conditions

Ischemic Stroke

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home Blood Pressure Monitoring Device (Qardio Arm)

Primary Care Provider Blood Pressure Management

Study Details

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.

Conditions

Ischemic Stroke

Hypertension

Study ID

NCT04226157

Start date

Feb 21, 2019

Status verified date

Apr, 2020

Completion date

Mar 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Usual Care

The Usual Care group will have their blood pressure monitored and medications adjusted by their primary care provider.

Interventions

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.

Primary Care Provider Blood Pressure Management

Participant will follow up as would normally do with primary care provider for blood pressure management.

Primary outcome measure

  • Feasibility of blood pressure self management in stroke survivors [ Time Frame: Three Months ]

Central Contacts and Locations

Central contacts

Mary Carter Denny, MD

202-444-8532MaryCarter.Denny@medstar.net

Locations

Medstar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Mary Carter Denny

202-444-8532MaryCarter.Denny@medstar.net

More Information

Sponsor

MedStar Georgetown University Hospital

Last update posted

Apr 9, 2020

Last verified

Apr, 2020

Keywords

  • Blood Pressure
  • Stroke
  • Hypertension
  • Blood Pressure Monitor
  • Home Blood Pressure Monitor
  • Ischemic Stroke
  • Stroke Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedStar Georgetown University Hospital on 2020-04-09.