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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Physical Activity Score Change (Life's Essential 8 Component)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Physical Activity Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention. Physical activity will be measured by the International Physical Activity Questionnaire (IPAQ).
Blood Pressure Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Average of 3 sitting measurements of systolic and diastolic pressures (mmHg).
Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past tobacco use habits.
Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Fingerstick blood collection (mg/dL).
Dietary Quality Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern.
Life's Essential 8 Composite Score change
时间窗: Baseline, 6-months and 12-months post-randomization
Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).
Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Fingerstick blood collection (fasting glucose-mg/dL; Hemoglobin A1c-%).
Body Mass Index (BMI) Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Calculated by weight (kg) and height (m).
Sleep Health Score Change (Life's Essential 8 Component)
时间窗: Baseline, 6-months and 12-months post-randomization
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).
次要结局
- Digital Health Readiness(Baseline, 3 months post-randomization)
- Social Support - Diet(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Cardio-ankle vascular index (CAVI)(Baseline, 6 months and 12 months post-randomization)
- Self Regulation - Physical Activity(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Perceived Barriers - Physical Activity(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Self Regulation - Diet(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Perceived Barriers - Diet(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Social Support - Physical Activity(Baseline, 3 months, 6 months, and 12 months post-randomization)
- Artificial Intelligence (AI)-Electrocardiogram (ECG)(Baseline, 6 months and 12 months post-randomization)
研究者
LaPrincess C. Brewer
Associate Professor of Medicine
Mayo Clinic