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

Mayo Clinic

Status: Enrolling

Conditions: Hypertension

Treatments: Behavioral: FAITH! HTN app

Study type: Interventional

Funder types: Other

Identifiers

NCT06346886

23-011703

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: FAITH! HTN app

Control Group

No Intervention group

Description:

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