Clinical trial NCT06346886: HTN App for HTN Control and Cardiovascular Health Among African-Americans
Official title: FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Miami Heart Research Institute Inc.
First posted: 2024-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change in Systolic Blood Pressure (BP)
timeFrame: Baseline, immediate post intervention
measure: HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
timeFrame: Baseline, immediate, 3 months, 6 months post intervention
Secondary outcomes:
measure: Proportion of subjects reaching BP control
timeFrame: Immediate, 3 months, 6 months post intervention
measure: Change in BP as assessed by home BP cuff measurements
timeFrame: Baseline, immediate post intervention
measure: CV Health Knowledge as measured by module assessment scores
timeFrame: Immediate post intervention
measure: Hypertension (HTN) Knowledge as assessed by 11-item questionnaire
timeFrame: Baseline, immediate post intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess Brewer, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References: