HypertensionNCT06346886
HTN App for HTN Control and Cardiovascular Health Among African-Americans
A study testing FAITH! HTN app in people with Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- FAITH! HTN app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African-American (AA) adults that are established patients at Neighborhood HealthSource in Minneapolis, Minnesota.
- Receives primary care (i.e., has designated primary care provider) at the partnering FQHCs and intent to continue care there for next 12 months
- African American race/ethnicity
- Men and women aged ≥18 years
- Uncontrolled HTN (defined as Stage 2 HTN with a BP ≥140/90 mmHg [as per 2017 American College of Cardiology/American Heart Association HTN Guidelines32] at most recent outpatient evaluation, with or without BP medications)
- Documented diagnosis of HTN in EHR
Show all 11Show fewer
- At least 1 office visit at the partnering FQHCs in the prior year
- Smartphone ownership (supporting iOS or Android Systems)
- Active email address and willingness to utilize it throughout the study
- Basic Internet navigation skills (for example, can search for information on websites, open and send emails)
- Access to the Internet on at least a weekly basis (such as at home, a family member's or friend's home, church, library/community center, school/university, Internet café, etc.)?
Who cannot join
- Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).
- No primary care provider at partnering FQHC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lainey Moen, 507-266-7062, Moen.Lainey@mayo.edu
Ashton Krogman, (507) 266-2087, Krogman.Ashton@mayo.edu
About this study
Official title: FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.
- Conditions
- Hypertension
- Being tested
- FAITH! HTN app
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAITH! HTN appBehavioural
Participants will remain in the intervention for 11 weeks. The app-based intervention is a tailored program to promote HTN self-management and knowledge through an 11-module educational video series with a focus on HTN. Participants will also be provided with at home Blood Pressure (BP) monitoring system to allow for self-tracking of BP measurements(automatically synchronized with the app). The app will include pre-post module quizzes, a tracking component for participants to input self-monitored measures (medication adherence, diet, physical activity, etc.). The app sharing board will be a moderated discussion platform and feed for participant interaction by posting healthy lifestyle practices through text, photographs and video to foster discussion on HTN management barriers/facilitators. The project team will post weekly to the sharing board on HTN-related topics to generate discussion among patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | African American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app. Receives: Behavioral: FAITH! HTN app |
| Control Group | No intervention | African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Systolic Blood Pressure (BP)
Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.
Measured: Baseline, immediate post intervention
HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
The H-SCALE is a 31-item instrument that assesses 6 HTN behavioral self-care activities recommended for optimal HTN management (BP medication adherence, weight loss/ideal body weight maintenance, adoption of a low-salt diet, regular physical activity for ≥30 minutes/day, limiting alcohol intake, and ceasing tobacco use).
Measured: Baseline, immediate, 3 months, 6 months post intervention
Secondary outcomes (4)
Proportion of subjects reaching BP control
Proportion of subjects reaching BP control (defined as meeting target BP of <140/90 mmHg)
Measured: Immediate, 3 months, 6 months post intervention
Change in BP as assessed by home BP cuff measurements
BP (mmHg) will be measured 3 times per week during the 11-week intervention period using a home BP monitoring system. The 3 weekly measurements will be averaged and average weekly BP will be compared from baseline to immediate post intervention to determine the change in BP. This outcome is only evaluated in the intervention group as the control group will not undergo home BP cuff measurements.
Measured: Baseline, immediate post intervention
CV Health Knowledge as measured by module assessment scores
Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients.
Measured: Immediate post intervention
Hypertension (HTN) Knowledge as assessed by 11-item questionnaire
HTN Knowledge will be assessed using a previously validated 11-item questionnaire which asks participants questions about the definition, prevention, management and complications of hypertension. Responses are record as true, false or uncertain to each question with true response receiving a score of 1 and false or uncertain responses receiving a score of 0. Total scores on the questionnaire range from 0-11 with higher scores reflecting better HTN knowledge.
Measured: Baseline, immediate post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start15 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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 Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Miami Heart Research Institute Inc.
- Responsible party
- Principal investigator, LaPrincess C. Brewer, Mayo Clinic
- Investigators
- LaPrincess Brewer, M.D., M.P.H, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346886
- Sponsor's protocol ID
- 23-011703
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06346886
- Acronym / sponsor ID
- 23-011703
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Miami Heart Research Institute Inc.
- Study start
- 15 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Apr 2024 (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 hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: FAITH! HTN appAfrican American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app. |
| Control Group | No intervention | –African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- African-American (AA) adults that are established patients at Neighborhood HealthSource in Minneapolis, Minnesota.
- Receives primary care (i.e., has designated primary care provider) at the partnering FQHCs and intent to continue care there for next 12 months
- African American race/ethnicity
- Men and women aged ≥18 years
- Uncontrolled HTN (defined as Stage 2 HTN with a BP ≥140/90 mmHg [as per 2017 American College of Cardiology/American Heart Association HTN Guidelines32] at most recent outpatient evaluation, with or without BP medications)
Key exclusion criteria (2 listed)
- Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).
- No primary care provider at partnering FQHC
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 |
|---|---|---|
| FAITH! HTN appParticipants will remain in the intervention for 11 weeks. The app-based intervention is a tailored program to promote HTN self-management and knowledge through an 11-module educational video series with a focus on HTN. Participants will also be provided with at home Blood Pressure (BP) monitoring system to allow for self-tracking of BP measurements(automatically synchronized with the app). The app will include pre-post module quizzes, a tracking component for participants to input self-monitored measures (medication adherence, diet, physical activity, etc.). The app sharing board will be a moderated discussion platform and feed for participant interaction by posting healthy lifestyle practices through text, photographs and video to foster discussion on HTN management barriers/facilitators. The project team will post weekly to the sharing board on HTN-related topics to generate discussion among patients. | Behavioural | Intervention Group |
Primary outcome
Absolute Change in Systolic Blood Pressure (BP)
Time frame: Baseline, immediate post intervention
Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.
HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
Time frame: Baseline, immediate, 3 months, 6 months post intervention
The H-SCALE is a 31-item instrument that assesses 6 HTN behavioral self-care activities recommended for optimal HTN management (BP medication adherence, weight loss/ideal body weight maintenance, adoption of a low-salt diet, regular physical activity for ≥30 minutes/day, limiting alcohol intake, and ceasing tobacco use).
4 secondary outcomes
Proportion of subjects reaching BP control
Time frame: Immediate, 3 months, 6 months post intervention
Change in BP as assessed by home BP cuff measurements
Time frame: Baseline, immediate post intervention
CV Health Knowledge as measured by module assessment scores
Time frame: Immediate post intervention
Hypertension (HTN) Knowledge as assessed by 11-item questionnaire
Time frame: Baseline, immediate post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
LaPrincess Brewer, M.D., M.P.H principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAITH! HTN app in people with Hypertension, run by Mayo Clinic 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lainey Moen (507-266-7062, Moen.Lainey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Systolic Blood Pressure (BP) (time frame: Baseline, immediate post intervention). The study lists 2 primary outcomes in all. 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 27 Feb 2026.