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

Primary Purpose

Hypertension, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
USeeBP
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

USeeBP

Arm Description

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

Outcomes

Primary Outcome Measures

Change in home BP
measured by Bluetooth enabled, electronic, at home BP cuff

Secondary Outcome Measures

Change in BP control rate
measured by clinical BP cuff, BP control defined as clinically-measured BP < 140/90 mmHg
Change in medication adherence
measured by Morisky Medication Adherence Scale
Number of EPIC myChart patient-provider messages and replies
total number of messages and replies
Number of hypertension related unscheduled emergency department or urgent care visits
total number of visits

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT06078540
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
USeeBP
Arm Type
Experimental
Arm Description
Participants will be asked to use the USeeBP mHealth app alongside participating in UCM-RPM program as part of their routine care.
Intervention Type
Other
Intervention Name(s)
USeeBP
Intervention Description
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;
Primary Outcome Measure Information:
Title
Change in home BP
Description
measured by Bluetooth enabled, electronic, at home BP cuff
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change in BP control rate
Description
measured by clinical BP cuff, BP control defined as clinically-measured BP < 140/90 mmHg
Time Frame
Baseline, Week 12
Title
Change in medication adherence
Description
measured by Morisky Medication Adherence Scale
Time Frame
Baseline, Week 12
Title
Number of EPIC myChart patient-provider messages and replies
Description
total number of messages and replies
Time Frame
Week 12
Title
Number of hypertension related unscheduled emergency department or urgent care visits
Description
total number of visits
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Roy
Phone
(773) 834-4135
Email
sararoy@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G. Beiser, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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