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A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans

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The University of Chicago

Status

Enrolling

Conditions

Hypertension
Blood Pressure

Treatments

Other: USeeBP

Study type

Interventional

Funder types

Other

Identifiers

NCT06078540
IRB23-1110

Details and patient eligibility

About

The purpose of this study is to test the proof-of-concept for adding a novel mHealth application, USeeBP, to the established UChicago Medicine Ambulatory Medicine Remote-Patient Monitoring (UCM-RPM) Hypertension Management Program in a population of African American adults with poorly controlled hypertension.

Full description

This is a single-arm, proof of concept study, which we will use to assess for initial evidence of efficacy and technical feasibility of adding the USeeBP mHealth app as an adjunct to the UCM-RPM program.

This study integrates the USeeBP app into the existing UCM-RPM clinical pathway. Regular UCM-RPM program activities include monitoring home blood pressure (BP) measurement flowsheets, performing patient telephone and EPIC MyChart message outreach, and making medication adjustments. USeeBP is a secure, chat-based smartphone application. The app connects to a patient's electronic BP cuff (eCuff) via Bluetooth and sends BP data to the UCM-RPM program (rather than using the companion app to the eCuff that is used in the UCM-RPM program). The USeeBP app also allows the patient to set BP check and medication reminders, as well as provides patient education and opportunities to participate in healthy behavior challenges.

The primary study goal is to measure the effect of the USeeBP mobile app on home BP. Serial home blood pressure measurements will be collected at multiple time points. We hypothesize that there will be a decrease in BP across the study period.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • African American
  • Ages 18 to 65 years old
  • Able to demonstrate English reading literacy of at least 8th grade level [Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) score ≥ 6]
  • Prior hypertension (HTN) diagnosis
  • Clinically measured SBP ≥ 160 mmHg recorded during at least 2 of last 4 encounters within past 2 years
  • UCM-RPM Hypertension Management Program current or eligible participant
  • Access to an Android or Apple iOS smartphone and its corresponding health app
  • Access to an active data plan or home Wi-Fi
  • Willing to use wireless electronic blood pressure cuff (eCuff)
  • Has access to EPIC myChart mobile app or is willing to establish myChart account and download app
  • Willing to download USeeBP study app to phone
  • Willing to download and use USeeBP app with staff assistance

Exclusion criteria

  • Hypertension is managed by a specialist (specialist prescribes the anti-hypertensive therapies)
  • Baseline blood pressure greater than 180/110
  • Prior enrollment in the study
  • Known pregnancy
  • Prisoners
  • Active opioid dependency
  • Homelessness
  • Psychiatric hospitalization in the last year
  • Serious existing medical conditions that may make BP control difficult or necessitate frequent hospitalization (cirrhosis or hepatic failure, stage IV or V chronic kidney disease, interstitial nephritis, pulmonary arterial hypertension, right heart failure, history of dementia or neurocognitive disability, advanced heart failure, organ transplant, immunosuppressive therapy, active cancer treatment, patients on hospice care), stroke or myocardial infarction in past 90 days, severe aortic stenosis
  • Hospital admission for primary diagnosis of hypertensive emergency, hypertensive urgency, or uncontrolled hypertension in the past 90 days

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

USeeBP
Experimental group
Description:
Participants will be asked to use the USeeBP mHealth app alongside participating in UCM-RPM program as part of their routine care.
Treatment:
Other: USeeBP

Trial contacts and locations

1

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Central trial contact

Sara Roy

Data sourced from clinicaltrials.gov

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