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

Hypertension Clinical Trial

— HBPS  

Official title:

Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226157
• Other study ID #: 2018-0718
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2020
• Source: MedStar Georgetown University Hospital
• Contact: Mary Carter Denny, MD
• Phone: 202-444-8532
• Email: MaryCarter.Denny[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Ischemic Stroke
• Stroke

Intervention

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:
• Primary Care Provider Blood Pressure Management
Participant will follow up as would normally do with primary care provider for blood pressure management.

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
MedStar Georgetown University Hospital	Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (17)

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Boden-Albala B, Quarles LW. Education strategies for stroke prevention. Stroke. 2013 Jun;44(6 Suppl 1):S48-51. doi: 10.1161/STROKEAHA.111.000396. Review. — View Citation

de Man-van Ginkel JM, Hafsteinsdóttir 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. — View Citation

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Lager KE, Mistri AK, Khunti K, Haunton VJ, Sett AK, Wilson AD. Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev. 2014 May 2;(5):CD009103. doi: 10.1002/14651858.CD009103.pub2. Review. Update in: Cochrane Database Syst Rev. 2018 May 07;5:CD009103. — View Citation

Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009 May 19;338:b1665. doi: 10.1136/bmj.b1665. Review. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2014 Nov 26;312(20):2169. Gooding, Trevor [Added]; Morrey, Ian [Added]; Fisher, Crispin [Added]; Buckley, David [Added]. — View Citation

Ovbiagele B, Nguyen-Huynh MN. Stroke epidemiology: advancing our understanding of disease mechanism and therapy. Neurotherapeutics. 2011 Jul;8(3):319-29. doi: 10.1007/s13311-011-0053-1. Review. — View Citation

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Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. Review. Erratum in: Hypertension. 2018 Jun;71(6):e140-e144. — View Citation

White CL, Pergola PE, Szychowski JM, Talbert R, Cervantes-Arriaga A, Clark HD, Del Brutto OH, Godoy IE, Hill MD, Pelegrí A, Sussman CR, Taylor AA, Valdivia J, Anderson DC, Conwit R, Benavente OR; SPS3 Investigators. Blood pressure after recent stroke: baseline findings from the secondary prevention of small subcortical strokes trial. Am J Hypertens. 2013 Sep;26(9):1114-22. doi: 10.1093/ajh/hpt076. Epub 2013 Jun 4. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systolic Blood Pressure Difference	Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.	three months