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Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic* (HBPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226157
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Dr. Mary Carter Denny, MedStar Georgetown University Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Systolic Blood Pressure Difference [ Time Frame: three months ]
    Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


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

Locations
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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   
Sponsors and Collaborators
MedStar Georgetown University Hospital
Medstar Health Research Institute
Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Dr. Mary Carter Denny, Assistant Professor of Neurology, MedStar Georgetown University Hospital
ClinicalTrials.gov Identifier: NCT04226157    
Other Study ID Numbers: 2018-0718
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Mary Carter Denny, MedStar Georgetown University Hospital:
Blood Pressure
Stroke
Hypertension
Blood Pressure Monitor
Home Blood Pressure Monitor
Ischemic Stroke
Stroke Prevention
Additional relevant MeSH terms:
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Stroke
Hypertension
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases