What this study is
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.
What's being tested
- FAITH! HTN app
Intervention · BEHAVIORAL
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 details
- Official title
- FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
- Sponsor
- Mayo Clinic
- Conditions
- Hypertension
- Enrolling
- 100 people
- Starts
- 2025-05-15
- Est. completion
- 2026-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.)?
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
- Lainey Moen · Contact507-266-7062Moen.Lainey@mayo.edu
- Ashton Krogman · Contact(507) 266-2087Krogman.Ashton@mayo.edu
- LaPrincess Brewer, M.D., M.P.H. · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 23-011703
Principal investigator
LaPrincess Brewer, M.D., M.P.H
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.