HypertensionNCT06078540
A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
A study testing USeeBP in people with Hypertension and Blood Pressure, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- USeeBP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- USeeBP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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;
| Study group | Role | What they receive |
|---|---|---|
| USeeBP | Experimental | Participants will be asked to use the USeeBP mHealth app alongside participating in UCM-RPM program as part of their routine care. Receives: Other: USeeBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in home BP
systolic pressure over diastolic pressure; measured by Bluetooth enabled, electronic, at home BP cuff
Measured: Baseline, Week 12
Secondary outcomes (4)
Change in BP control rate
measured by clinical BP cuff, BP control defined as clinically-measured BP < 140/90 mmHg
Measured: Baseline, Week 12
Change in medication adherence
measured by Medication Adherence Report Scale (MARS-5); minimum value is 5, maximum value is 25; lower values indicate worse medication adherence
Measured: Baseline, Week 12
Number of EPIC myChart patient-provider messages and replies
total number of messages and replies
Measured: Week 12
Number of hypertension related unscheduled emergency department or urgent care visits
total number of visits
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start27 Oct 2023
- Primary completion5 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G. Beiser, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078540
- Sponsor's protocol ID
- IRB23-1110
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
- ClinicalTrials.gov ID
- NCT06078540
- Acronym / sponsor ID
- IRB23-1110
- Conditions
- Hypertension, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USeeBP | Experimental | Other: USeeBPParticipants will be asked to use the USeeBP mHealth app alongside participating in UCM-RPM program as part of their routine care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USeeBPUSeeBP 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; | Other | USeeBP |
Primary outcome
Change in home BP
Time frame: Baseline, Week 12
systolic pressure over diastolic pressure; measured by Bluetooth enabled, electronic, at home BP cuff
4 secondary outcomes
Change in BP control rate
Time frame: Baseline, Week 12
Change in medication adherence
Time frame: Baseline, Week 12
Number of EPIC myChart patient-provider messages and replies
Time frame: Week 12
Number of hypertension related unscheduled emergency department or urgent care visits
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G. Beiser, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USeeBP in people with Hypertension and Blood Pressure, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in home BP (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.