Home BP Monitoring

NCT ID: NCT05552547

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-09-30

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Home Blood Pressure Machine

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

Group Type: ACTIVE_COMPARATOR

Home Blood Pressure Machine

Intervention Type: DEVICE

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 this machine for 24 hours.

Group Type: EXPERIMENTAL

24-Hour Blood Pressure Machine

Intervention Type: DEVICE

Participants will be asked to wear the 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.

Intervention Type: DEVICE

24-Hour Blood Pressure Machine

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Goutham Rao, MD

Chairman, Department of Family Medicine and Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rao Goutham, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Goutham Rao, MD

Role: CONTACT

goutham.rao@uhhospitals.org

(216)844-3791

Facility Contacts

Goutham Rao, MD

Role: primary

Goutham.Rao@UHhospitals.org

(216)844-3791

Other Identifiers

STUDY20221105

Identifier Type: -

Identifier Source: org_study_id