Clinical trial NCT05552547: Home BP Monitoring
Official title: Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Blood Pressure
Keywords: African American Teen
Home blood pressure monitoring
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 750
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of participants who meet criteria for hypertension based on average home BP reading.
timeFrame: Up to 2 weeks
measure: Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.
timeFrame: Up to 24 hours
measure: Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM
timeFrame: Up to 2 weeks
measure: True positive rate -- Number of home bp positives over ABPM positives
timeFrame: Up to 2 weeks
measure: True negative rate -- Number of home bp negatives over ABPM negatives
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Number of subjects who complete home BP protocol
timeFrame: Up to 2 weeks
measure: Number of subjects who complete both home BP verus 24-hour ABPM protocols
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Rao Goutham, MD
role: PRINCIPAL_INVESTIGATOR
References: