Home BP Monitoring

Official title

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

Overview

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.

Interventions

• Device Home Blood Pressure Machine
  Participants will be asked to measure blood pressure twice daily for three days in a row at home.
• Device 24-Hour Blood Pressure Machine
  Participants will be asked to wear the machine for 24 hours.

Primary outcome measures

• Number of participants who meet criteria for hypertension based on average home BP reading. [Time frame: Up to 2 weeks]
• Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading. [Time frame: Up to 24 hours]
• Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM [Time frame: Up to 2 weeks]
• True positive rate -- Number of home bp positives over ABPM positives [Time frame: Up to 2 weeks]
• True negative rate -- Number of home bp negatives over ABPM negatives [Time frame: Up to 2 weeks]

Secondary outcome measures (2)

• Number of subjects who complete home BP protocol [Time frame: Up to 2 weeks]
• Number of subjects who complete both home BP verus 24-hour ABPM protocols [Time frame: Up to 3 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University Hospitals Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT05552547 · STUDY20221105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗