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

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT06078540
Collaborator
(none)
30
1
1
12
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: USeeBP
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: USeeBP

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

Other: USeeBP
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;

Outcome Measures

Primary Outcome Measures

  1. Change in home BP [Baseline, Week 12]

    measured by Bluetooth enabled, electronic, at home BP cuff

Secondary Outcome Measures

  1. Change in BP control rate [Baseline, Week 12]

    measured by clinical BP cuff, BP control defined as clinically-measured BP < 140/90 mmHg

  2. Change in medication adherence [Baseline, Week 12]

    measured by Morisky Medication Adherence Scale

  3. Number of EPIC myChart patient-provider messages and replies [Week 12]

    total number of messages and replies

  4. Number of hypertension related unscheduled emergency department or urgent care visits [Week 12]

    total number of visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 greater than or equal to 160 mmHg recorded during the last 2 encounters

  • Clinically measured SBP greater than or equal to 160 mmHg recorded within the last year

  • UCM-RPM Hypertension Management Program current or eligible participant

  • Access to an Apple iPhone compatible with Apple 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: David G. Beiser, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT06078540
Other Study ID Numbers:
  • IRB23-1110
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2023