Home BP Monitoring

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity Hospitals Cleveland Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Home Blood Pressure Machine

    Device

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

  • 24-Hour Blood Pressure Machine

    Device

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

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Home Blood Pressure MachineActive comparator 1 intervention
Group B: 24-Hour Blood Pressure MachineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who meet criteria for hypertension based on average home BP reading.

Time frame
Up to 2 weeks
2

Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.

Time frame
Up to 24 hours
3

Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM

Time frame
Up to 2 weeks
4

True positive rate -- Number of home bp positives over ABPM positives

Time frame
Up to 2 weeks

Secondary outcomes

1

Number of subjects who complete home BP protocol

Time frame
Up to 2 weeks
2

Number of subjects who complete both home BP verus 24-hour ABPM protocols

Time frame
Up to 3 weeks

Other outcomes

Sponsors and contacts

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