Recruiting

HTN App

Sponsor:

Mayo Clinic

Code:

NCT06346886

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAITH! HTN app

Study Details

Brief 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.

Conditions

Hypertension

Study ID

NCT06346886

Start date

May 15, 2025

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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.)?

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

African American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app.

no intervention: Control Group

African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management.

Interventions

FAITH! HTN app

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.

Primary outcome measure

  • Absolute Change in Systolic Blood Pressure (BP) [ Time Frame: Baseline, immediate post intervention ]
  • HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) [ Time Frame: Baseline, immediate, 3 months, 6 months post intervention ]

Central Contacts and Locations

Central contacts

Lainey Moen

507-266-7062Moen.Lainey@mayo.edu

Ashton Krogman

507-266-2087Krogman.Ashton@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lainey Moen

507-266-7062Moen.Lainey@mayo.edu

Ashton Krogman

(507) 266-2087Krogman.Ashton@mayo.edu

Principal Investigator:

LaPrincess Brewer, M.D., M.P.H.

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-27.