Home BP Monitoring

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

Most cases of high blood pressure in teens are missed for a number of reasons. One reason is that the most common way to make a diagnosis is to make three or more blood pressure measurements in a doctor's office on separate days. This can be inconvenient. Also, measuring blood pressure in the office might be inaccurate, since children (including teens) might have high values in the office but normal values at home. For these reasons, investigators wish to study a different way to identify teens with high blood pressure. Home BP measurements have been used in Europe to make a diagnosis, but not yet in the United States, and never in a higher risk population of teens. African American teens are at higher risk for high blood pressure than other teens. Investigators will compare the values received from the home BP machines to another method (24 hour ambulatory BP monitoring or ABPM) which is the best standard for diagnosis. Investigators also want to learn more about participants experience and their child's experience with both methods. A small sample of participating teens and parents will be invited to participate in short telephone interviews. This study plans to enroll a total of 750 teens at UH. Recruitment will not take place from other organizations.

Study Overview

• Status: Recruiting
• Conditions: High Blood Pressure
• Intervention / Treatment: Device: Home Blood Pressure Machine; Device: 24-Hour Blood Pressure Machine

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Goutham Rao, MD; Phone Number: (216)844-3791; Email: Goutham.Rao@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Goutham Rao, MD; Phone Number: (216)844-3791; Email: Goutham.Rao@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-identify or identified by a parent as African-American or of partly African American ancestry

Exclusion Criteria:

• Prior hypertension diagnosis
• Prescribed BP medication
• History of congenital heart disease
• History of solid organ transplant
• Prescribed and using stimulants and other medications on a regular basis known to raise blood pressure such as testosterone and nicotine replacement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Home Blood Pressure Machine; Participants will be asked to measure blood pressure twice daily for three days in a row.	Device: Home Blood Pressure Machine; Participants will be asked to measure blood pressure twice daily for three days in a row at home.
Experimental: 24-Hour Blood Pressure Machine; Participants will be asked to wear this machine for 24 hours.	Device: 24-Hour Blood Pressure Machine; Participants will be asked to wear the machine for 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who meet criteria for hypertension based on average home BP reading.	Up to 2 weeks
Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.	Up to 24 hours
Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM	Up to 2 weeks
True positive rate -- Number of home bp positives over ABPM positives	Up to 2 weeks
True negative rate -- Number of home bp negatives over ABPM negatives	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects who complete home BP protocol	Up to 2 weeks
Number of subjects who complete both home BP verus 24-hour ABPM protocols	Up to 3 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Rao Goutham, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Home blood pressure monitoring; African American Teen
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: STUDY20221105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No