~187 spots leftby Oct 2025

Home BP Monitoring for High Blood Pressure

Recruiting in Palo Alto (17 mi)
RG
Overseen byRao Goutham, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Hospitals Cleveland Medical Center
Must not be taking: Stimulants, Testosterone, Nicotine
Disqualifiers: Hypertension, Heart disease, Organ transplant, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are already prescribed blood pressure medication or regularly use stimulants or other medications that raise blood pressure, you would not be eligible to participate.

What data supports the effectiveness of the treatment Home BP Monitoring for High Blood Pressure?

Research shows that home blood pressure monitoring (HBPM) helps people control their blood pressure better and stick to their medication plans. It provides more data for doctors and patients to manage high blood pressure effectively.12345

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring (HBPM) is generally considered safe for humans. It is a reliable and convenient method for managing high blood pressure, and there is no evidence suggesting it poses any safety risks.24567

How is home blood pressure monitoring different from other treatments for high blood pressure?

Home blood pressure monitoring (HBPM) is unique because it allows patients to measure their blood pressure at home, providing more frequent and accurate readings than those taken in a doctor's office. This method helps avoid the 'white-coat effect' (where blood pressure rises in a clinical setting) and better predicts cardiovascular risk by offering readings closer to those from 24-hour monitoring.258910

Research Team

RG

Rao Goutham, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for African American teens without a prior hypertension diagnosis, no history of organ transplant, not on stimulants or blood pressure meds, and no congenital heart disease. It aims to find better ways to diagnose high blood pressure in this group.

Inclusion Criteria

You or your parent have identified as African-American or partly African-American.

Exclusion Criteria

I have had a solid organ transplant.
I have been diagnosed with high blood pressure.
I was born with a heart condition.
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Blood Pressure Monitoring

Participants will measure blood pressure twice daily for three days in a row using a home blood pressure machine

1 week
No in-person visits required

24-Hour Ambulatory Blood Pressure Monitoring

Participants will wear a 24-hour blood pressure machine for continuous monitoring

1 day
1 visit (in-person) for device setup and removal

Follow-up

Participants are monitored for safety and effectiveness after blood pressure monitoring

4 weeks

Treatment Details

Interventions

  • Home BP Monitoring (Behavioural Intervention)
Trial OverviewThe study compares home blood pressure monitoring with the gold standard 24-hour ambulatory BP monitoring (ABPM) to see which is more effective at diagnosing high blood pressure in African American teens.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-Hour Blood Pressure MachineExperimental Treatment1 Intervention
Participants will be asked to wear this machine for 24 hours.
Group II: Home Blood Pressure MachineActive Control1 Intervention
Participants will be asked to measure blood pressure twice daily for three days in a row.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+
Dr. Brett Glotzbecker profile image

Dr. Brett Glotzbecker

University Hospitals Cleveland Medical Center

Chief Medical Officer since 2023

MD

Dr. Cliff Megerian profile image

Dr. Cliff Megerian

University Hospitals Cleveland Medical Center

Chief Executive Officer

MD, MBA

Goutham Rao, MD

Lead Sponsor

Trials
1
Recruited
750+

Findings from Research

A study of 452 hypertensive patients in Turkey revealed that most patients chose their home sphygmomanometers based on simplicity and ease of use, rather than on their accuracy or validation status.
None of the patients were aware of whether their home sphygmomanometers were validated or calibrated, indicating a significant gap in knowledge that could lead to inaccurate blood pressure readings and potential mismanagement of hypertension.
How do we measure blood pressure at home?Bardak, S., Turgutalp, K., Özcan, T., et al.[2015]
In a study of 213 adults with hypertension over 3 months, home blood pressure monitoring (HBPM) combined with a health education session did not significantly reduce blood pressure or improve medication adherence compared to usual care.
While the HBPM group showed some reduction in blood pressure, it was not greater than the control group, suggesting that more effective educational interventions and sharing blood pressure data might enhance outcomes in future studies.
The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial.Cuffee, YL., Sciamanna, C., Gerin, W., et al.[2022]
In a study involving 100 Alaska Native and American Indian participants with hypertension, the majority (66%) preferred wrist blood pressure monitoring devices over arm devices due to higher ratings in ease of use and comfort.
Despite valuing accuracy in home blood pressure monitoring, participants prioritized usability factors like comfort and ease of use when choosing a device, indicating that these characteristics are crucial for long-term management of hypertension.
Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples.Railey, AF., Dillard, DA., Fyfe-Johnson, A., et al.[2023]

References

Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. [2021]
How do we measure blood pressure at home? [2015]
The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. [2022]
Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. [2023]
[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] [2022]
Home Blood Pressure Monitoring: Current Status and New Developments. [2023]
Accuracy of home blood pressure measurement: the ACCURAPRESS study - a proposal of Young Investigator Group of the Italian Hypertension Society (Società Italiana dell'Ipertensione Arteriosa). [2022]
Call to action on use and reimbursement for home blood pressure monitoring: executive summary a joint scientific statement from the american heart association, american society of hypertension, and preventive cardiovascular nurses association. [2010]
Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Call to action on use and reimbursement for home blood pressure monitoring: Executive Summary. A joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. [2021]