Home BP Monitoring

University Hospitals (UH)

Status: Enrolling

Conditions: High Blood Pressure

Treatments: Device: 24-Hour Blood Pressure Machine; Device: Home Blood Pressure Machine

Study type: Interventional

Funder types: Other

Identifiers

NCT05552547

STUDY20221105

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Home Blood Pressure Machine

Active Comparator group

Description:

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

Treatment:

Device: Home Blood Pressure Machine

24-Hour Blood Pressure Machine

Experimental group

Description:

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

Treatment:

Device: 24-Hour Blood Pressure Machine