FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
Time Frame: Baseline, immediate, 3 months, 6 months post intervention
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).
Absolute Change in Systolic Blood Pressure (BP)
Time Frame: Baseline, immediate post intervention
Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.
Secondary Outcomes
- Change in BP as assessed by home BP cuff measurements(Baseline, immediate post intervention)
- Proportion of subjects reaching BP control(Immediate, 3 months, 6 months 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)
Investigators
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic