Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic* (HBPS)
Primary Purpose
Ischemic Stroke, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Blood Pressure Monitoring Device (Qardio Arm)
Primary Care Provider Blood Pressure Management
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke focused on measuring Blood Pressure, Stroke, Hypertension, Blood Pressure Monitor, Home Blood Pressure Monitor, Ischemic Stroke, Stroke Prevention
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
Sites / Locations
- Medstar Georgetown University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home Blood Pressure Self Management
Usual Care
Arm Description
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.
The Usual Care group will have their blood pressure monitored and medications adjusted by their primary care provider.
Outcomes
Primary Outcome Measures
Feasibility of blood pressure self management in stroke survivors
At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention.
Secondary Outcome Measures
Systolic Blood Pressure Difference
Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.
Full Information
NCT ID
NCT04226157
First Posted
January 9, 2020
Last Updated
April 8, 2020
Sponsor
MedStar Georgetown University Hospital
Collaborators
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04226157
Brief Title
Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*
Acronym
HBPS
Official Title
Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MedStar Georgetown University Hospital
Collaborators
Medstar Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hypertension
Keywords
Blood Pressure, Stroke, Hypertension, Blood Pressure Monitor, Home Blood Pressure Monitor, Ischemic Stroke, Stroke Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Blood Pressure Self Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
The Usual Care group will have their blood pressure monitored and medications adjusted by their primary care provider.
Intervention Type
Device
Intervention Name(s)
Home Blood Pressure Monitoring Device (Qardio Arm)
Other Intervention Name(s)
Medication Self-Titration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Primary Care Provider Blood Pressure Management
Intervention Description
Participant will follow up as would normally do with primary care provider for blood pressure management.
Primary Outcome Measure Information:
Title
Feasibility of blood pressure self management in stroke survivors
Description
At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention.
Time Frame
Three Months
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure Difference
Description
Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Carter Denny, MD
Phone
202-444-8532
Email
MaryCarter.Denny@medstar.net
Facility Information:
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Carter Denny
Phone
202-444-8532
Email
MaryCarter.Denny@medstar.net
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*
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