Clinical trial NCT06078540: A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
Official title: A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Blood Pressure
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in home BP
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in BP control rate
timeFrame: Baseline, Week 12
measure: Change in medication adherence
timeFrame: Baseline, Week 12
measure: Number of EPIC myChart patient-provider messages and replies
timeFrame: Week 12
measure: Number of hypertension related unscheduled emergency department or urgent care visits
timeFrame: Week 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: David G. Beiser, MD
role: PRINCIPAL_INVESTIGATOR
References: