HTN App for HTN Control and Cardiovascular Health Among African-Americans

NCT06346886 | Recruiting

• 1 other identifier: 23-011703
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Baseline, immediate, 3 months, 6 months post intervention

Secondary Outcomes (4)

• Proportion of subjects reaching BP control

  Immediate, 3 months, 6 months post intervention

• Change in BP as assessed by home BP cuff measurements

  Baseline, immediate post intervention

• CV Health Knowledge as measured by module assessment scores

  Immediate post intervention

• Hypertension (HTN) Knowledge as assessed by 11-item questionnaire

  Baseline, immediate post intervention

Study Arms (2)

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.

Behavioral: FAITH! HTN app

Control Group

NO INTERVENTION

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

Interventions

FAITH! HTN app 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Miami Heart Research Institute Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• LaPrincess Brewer, M.D., M.P.H

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lainey Moen

CONTACT

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

Ashton Krogman

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)