Recruiting

Home BP Measurements

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05552547

Conditions

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Interventions

Home Blood Pressure Machine

24-Hour Blood Pressure Machine

Study Details

Brief summary:

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.

Conditions

High Blood Pressure

Study ID

NCT05552547

Start date

Oct 1, 2023

Status verified date

Dec, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

750 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Home Blood Pressure Machine

Participants will be asked to measure blood pressure twice daily for three days in a row.

experimental: 24-Hour Blood Pressure Machine

Participants will be asked to wear this machine for 24 hours.

Interventions

Home Blood Pressure Machine

Participants will be asked to measure blood pressure twice daily for three days in a row at home.

24-Hour Blood Pressure Machine

Participants will be asked to wear the machine for 24 hours.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • African American Teen
  • Home blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-12-10.