Home BP Monitoring
Primary Purpose
High Blood Pressure
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Blood Pressure Machine
24-Hour Blood Pressure Machine
Sponsored by

About this trial
This is an interventional prevention trial for High Blood Pressure focused on measuring African American Teen, Home blood pressure monitoring
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
Sites / Locations
- University Hospitals Cleveland Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Home Blood Pressure Machine
24-Hour Blood Pressure Machine
Arm Description
Participants will be asked to measure blood pressure twice daily for three days in a row.
Participants will be asked to wear this machine for 24 hours.
Outcomes
Primary Outcome Measures
Number of participants who meet criteria for hypertension based on average home BP reading.
Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.
Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM
True positive rate -- Number of home bp positives over ABPM positives
True negative rate -- Number of home bp negatives over ABPM negatives
Secondary Outcome Measures
Number of subjects who complete home BP protocol
Number of subjects who complete both home BP verus 24-hour ABPM protocols
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552547
Brief Title
Home BP Monitoring
Official Title
Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 21, 2025 (Anticipated)
Study Completion Date
October 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Goutham Rao, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
African American Teen, Home blood pressure monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Blood Pressure Machine
Arm Type
Active Comparator
Arm Description
Participants will be asked to measure blood pressure twice daily for three days in a row.
Arm Title
24-Hour Blood Pressure Machine
Arm Type
Experimental
Arm Description
Participants will be asked to wear this machine for 24 hours.
Intervention Type
Device
Intervention Name(s)
Home Blood Pressure Machine
Intervention Description
Participants will be asked to measure blood pressure twice daily for three days in a row at home.
Intervention Type
Device
Intervention Name(s)
24-Hour Blood Pressure Machine
Intervention Description
Participants will be asked to wear the machine for 24 hours.
Primary Outcome Measure Information:
Title
Number of participants who meet criteria for hypertension based on average home BP reading.
Time Frame
Up to 2 weeks
Title
Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.
Time Frame
Up to 24 hours
Title
Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM
Time Frame
Up to 2 weeks
Title
True positive rate -- Number of home bp positives over ABPM positives
Time Frame
Up to 2 weeks
Title
True negative rate -- Number of home bp negatives over ABPM negatives
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Number of subjects who complete home BP protocol
Time Frame
Up to 2 weeks
Title
Number of subjects who complete both home BP verus 24-hour ABPM protocols
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goutham Rao, MD
Phone
(216)844-3791
Email
goutham.rao@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rao Goutham, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goutham Rao, MD
Phone
216-844-3791
Email
Goutham.Rao@UHhospitals.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home BP Monitoring
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