About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identify or identified by a parent as African-American or of partly African American ancestry
Disqualifiers
Prior hypertension diagnosis
Prescribed BP medication
History of congenital heart disease
History of solid organ transplant
Trial design
Parallel
Treatments tested in this trial
Home Blood Pressure Machine
DeviceParticipants will be asked to measure blood pressure twice daily for three days in a row at home.
24-Hour Blood Pressure Machine
DeviceParticipants will be asked to wear the machine for 24 hours.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants who meet criteria for hypertension based on average home BP reading.
Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.
Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM
True positive rate -- Number of home bp positives over ABPM positives
Secondary outcomes
Number of subjects who complete home BP protocol
Number of subjects who complete both home BP verus 24-hour ABPM protocols
Sponsors and contacts
Click on the lead sponsor to view all of their trials.