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

NCT04226157 | Unknown

• 1 other identifier: 2018-0718
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Three Months

Secondary Outcomes (1)

• Systolic Blood Pressure Difference

  three months

Study Arms (2)

Home Blood Pressure Self Management

EXPERIMENTAL

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)

Usual Care

ACTIVE COMPARATOR

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

Interventions

Home Blood Pressure Monitoring Device (Qardio Arm) DEVICE

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.

Also known as: Medication Self-Titration

Home Blood Pressure Self Management

Primary Care Provider Blood Pressure Management OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MedStar Georgetown University Hospital: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Related Publications (17)

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  PMID: 27802419 BACKGROUND

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  PMID: 17431209 BACKGROUND

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  PMID: 23709728 BACKGROUND

• McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Gooding T, Morrey I, Fisher C, Buckley D. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014 Aug 27;312(8):799-808. doi: 10.1001/jama.2014.10057.

  PMID: 25157723 BACKGROUND

• Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.

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• Fernandez S, Chaplin W, Schoenthaler AM, Ogedegbe G. Revision and validation of the medication adherence self-efficacy scale (MASES) in hypertensive African Americans. J Behav Med. 2008 Dec;31(6):453-62. doi: 10.1007/s10865-008-9170-7. Epub 2008 Sep 11.

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• de Man-van Ginkel JM, Hafsteinsdottir T, Lindeman E, Burger H, Grobbee D, Schuurmans M. An efficient way to detect poststroke depression by subsequent administration of a 9-item and a 2-item Patient Health Questionnaire. Stroke. 2012 Mar;43(3):854-6. doi: 10.1161/STROKEAHA.111.640276. Epub 2011 Dec 8.

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MeSH Terms

Conditions

Ischemic Stroke; Hypertension; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mary Carter Denny, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: February 21, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

US (1)