Home BP Monitoring

NCT05552547 | Recruiting DMC

• 1 other identifier: STUDY20221105
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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

Keywords

African American Teen; Home blood pressure monitoring

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (2)

Home Blood Pressure Machine

ACTIVE COMPARATOR

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

Device: Home Blood Pressure Machine

24-Hour Blood Pressure Machine

EXPERIMENTAL

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

Device: 24-Hour Blood Pressure Machine

Interventions

24-Hour Blood Pressure Machine DEVICE

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

24-Hour Blood Pressure Machine

Home Blood Pressure Machine DEVICE

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

Home Blood Pressure Machine

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rao Goutham, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Goutham Rao, MD

CONTACT

(216)844-3791; goutham.rao@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Family Medicine and Community Health

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)