Home BP Monitoring

Not Applicable

Recruiting

• Conditions: High Blood Pressure
• Interventions: Device: Home Blood Pressure Machine; Device: 24-Hour Blood Pressure Machine

• Registration Number: NCT05552547
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Study Start: 2023-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-10-21
• Study Completion: 2025-10-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Blood Pressure Machine	Home Blood Pressure Machine	Participants will be asked to measure blood pressure twice daily for three days in a row.
24-Hour Blood Pressure Machine	24-Hour Blood Pressure Machine	Participants will be asked to wear this machine for 24 hours.

Primary Outcome Measures

Name	Time	Method
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 negative rate -- Number of home bp negatives over ABPM negatives	Up to 2 weeks
True positive rate -- Number of home bp positives over ABPM positives	Up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States