Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic* (HBPS)
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|ClinicalTrials.gov Identifier: NCT04226157|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Hypertension||Device: Home Blood Pressure Monitoring Device (Qardio Arm) Other: Primary Care Provider Blood Pressure Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study|
|Actual Study Start Date :||February 21, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
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 Name: 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.
- 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.
- Systolic Blood Pressure Difference [ Time Frame: three months ]Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226157
|Contact: Mary Carter Denny, MD||202-444-8532||MaryCarter.Denny@medstar.net|
|United States, District of Columbia|
|Medstar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Mary Carter Denny 202-444-8532 MaryCarter.Denny@medstar.net|