Techquity by FAITH!: A Cluster Randomized Controlled Trial To Assess the Efficacy of a Community-informed, Cardiovascular Health Promotion Mobile Intervention With Digital Health Advocate Support
Trial ID: NCT06187077
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-07-11
Completion date: 2026-06-30
Sponsor: Mayo Clinic
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Johns Hopkins University; Association of Black Cardiologists
Conditions: Health Equity; Cardiovascular Diseases
Interventions: DHA-Enhanced FAITH! App; FAITH! App
Locations: Mayo Clinic in Rochester
Countries: United States
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this clinical trial is to engage African-American churches via an established community-academic partnership (FAITH! Program) to build capacity to promote cardiovascular health and digital health equity in African-American faith communities. There are 3 study aims:

Aim 1: Co-design a culturally tailored digital health equity toolkit with community members

Aim 2: Train a network of Digital Health Advocates (DHAs) in digital health equity and cardiovascular health promotion

Aim 3: Test the impact of a DHA-enhanced mobile health intervention (the FAITH! App) on cardiovascular health and digital health readiness among participants

In Aim 1, participants will attend a series of focus groups to share their input on a digital health equity curriculum that will be condensed into a toolkit.

In Aim 2, DHAs will be trained using this toolkit as well as a community health advocacy curriculum to learn how to promote digital health readiness and cardiovascular health in their communities.

Finally, Aim 3 will be a randomized controlled trial where participants will use the FAITH! App to improve their cardiovascular health. Some participants will have the added support of a DHA, and the control group participants will use the app with no additional support to test whether the DHA support is associated with a more significant improvement in cardiovascular health.

Eligibility criteria:
Aim 1- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, basic Internet navigation skills, active email address

Aim 2- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, ownership of smartphone (supporting iOS or Android systems), moderate to high digital health literacy (by eHealth literacy scale \[eHEALS\], score ≥26)

Aim 3- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, ownership of smartphone (supporting iOS or Android systems), low digital health literacy (by eHEALS, score ≤26), basic Internet navigation skills, at least weekly Internet access, active email address, fruit/vegetable intake ≤5 servings/day, no regular physical activity, able to engage in moderate physical activity and willingness to participate in all aspects of the study.

Exclusion Criteria: Unable to walk up ≥2 flights of stairs or walk ≥1 city block without assistance or stopping, pregnant (at time of study enrollment), visual/hearing impairment or mental disability that would preclude independent app use.

Outcomes:
Life's Essential 8 Composite Score change; Blood Pressure Score Change (Life's Essential 8 Component); Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component); Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component); Body Mass Index (BMI) Score Change (Life's Essential 8 Component); Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component); Dietary Quality Score Change (Life's Essential 8 Component); Physical Activity Score Change (Life's Essential 8 Component); Sleep Health Score Change (Life's Essential 8 Component)