Clinical trial NCT06187077: Techquity by FAITH!
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Equity
Cardiovascular Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Johns Hopkins University
name: Association of Black Cardiologists
First posted: 2024-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study addresses cardiovascular health and digital health disparities faced by African-Americans (AAs). We propose three aims to engage with the AA community and build capacity for a digital literacy and cardiovascular health promotion. Aim 1 will engage AA churches to co-design a culturally relevant digital health equity toolkit through an iterative focus group process. In aim 1, we will recruit 20 AAs to represent their churches and be trained as digital health advocates (DHAs) by completing digital health readiness education (using the toolkit developed in aim 1) and cardiovascular health promotion. This advocacy program will be integrated into an existing mobile health intervention, the FAITH! App, in Aim 3. The impact of the community-informed, mHealth intervention, enhanced with DHA support, on AA adults' cardiovascular health will be assessed in a cluster randomized controlled trial. 150 participants will be be randomized to utilize the FAITH! App alone or with the support of the DHA at their church. Cardiovascular health will be assessed at baseline, approximately 3 months, 6 months, and 12 months post-randomization using the American Heart Association's Life's Essential 8 metric for 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.

Primary outcomes:
measure: Life's Essential 8 Composite Score change
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Blood Pressure Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Body Mass Index (BMI) Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Dietary Quality Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Physical Activity Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
measure: Sleep Health Score Change (Life's Essential 8 Component)
timeFrame: Baseline, 6-months and 12-months post-randomization
Secondary outcomes:
measure: Digital Health Readiness
timeFrame: Baseline, 3 months post-randomization
measure: Social Support - Diet
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Self Regulation - Diet
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Perceived Barriers - Diet
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Social Support - Physical Activity
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Self Regulation - Physical Activity
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Perceived Barriers - Physical Activity
timeFrame: Baseline, 3 months, 6 months, and 12 months post-randomization
measure: Artificial Intelligence (AI)-Electrocardiogram (ECG)
timeFrame: Baseline, 6 months and 12 months post-randomization
measure: Cardio-ankle vascular index (CAVI)
timeFrame: Baseline, 6 months and 12 months post-randomization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess Brewer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: