Home BP Monitoring
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Home Blood Pressure Machine Participants will be asked to measure blood pressure twice daily for three days in a row. |
Device: Home Blood Pressure Machine
Participants will be asked to measure blood pressure twice daily for three days in a row at home.
|
| Experimental: 24-Hour Blood Pressure Machine Participants will be asked to wear this machine for 24 hours. |
Device: 24-Hour Blood Pressure Machine
Participants will be asked to wear the machine for 24 hours.
|
Outcome Measures
Primary Outcome Measures
- Number of participants who meet criteria for hypertension based on average home BP reading. [Up to 2 weeks]
- Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading. [Up to 24 hours]
- Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM [Up to 2 weeks]
- True positive rate -- Number of home bp positives over ABPM positives [Up to 2 weeks]
- True negative rate -- Number of home bp negatives over ABPM negatives [Up to 2 weeks]
Secondary Outcome Measures
- Number of subjects who complete home BP protocol [Up to 2 weeks]
- Number of subjects who complete both home BP verus 24-hour ABPM protocols [Up to 3 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Self-identify or identified by a parent as African-American or of partly African American ancestry
Exclusion Criteria:
-
Prior hypertension diagnosis
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Prescribed BP medication
-
History of congenital heart disease
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History of solid organ transplant
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Prescribed and using stimulants and other medications on a regular basis known to raise blood pressure such as testosterone and nicotine replacement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Goutham Rao, MD
Investigators
- Principal Investigator: Rao Goutham, MD, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY20221105