NCT06078540

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2025

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

October 5, 2023

Last Update Submit

February 27, 2026

Conditions

HypertensionBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in home BP

    systolic pressure over diastolic pressure; measured by Bluetooth enabled, electronic, at home BP cuff

    Baseline, Week 12

Secondary Outcomes (4)

  • Change in BP control rate

    Baseline, Week 12

  • Change in medication adherence

    Baseline, Week 12

  • Number of EPIC myChart patient-provider messages and replies

    Week 12

  • Number of hypertension related unscheduled emergency department or urgent care visits

    Week 12

Study Arms (1)

USeeBP

EXPERIMENTAL

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

Other: USeeBP

Interventions

USeeBPOTHER

USeeBP is a low risk mobile medical app that proposes to do no more than: * Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; * Provide patients with simple tools to organize and track their health information; * Provide easy access to information related to patients' health conditions or treatments; * Help patients document, show, or communicate potential medical conditions to health care providers;

USeeBP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • David G. Beiser, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 12, 2023

Study Start

October 27, 2023

Primary Completion

July 5, 2025

Study Completion

July 5, 2025

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

US(1)