Home BP Monitoring

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT05552547
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
750 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Home Blood Pressure Machine
    Participants will be asked to measure blood pressure twice daily for three days in a row.
  • Experimental: 24-Hour Blood Pressure Machine
    Participants will be asked to wear this machine for 24 hours.

Primary Outcome Measure

Number of participants who meet criteria for hypertension based on average home BP reading. [ Time Frame: Up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Goutham Rao, MD
[email protected]
(216)844-3791

Find similar trials in Cleveland, OH

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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