Digital Health Apps for Cardiovascular Disease

Overseen By Moen Lainey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Mobility issues, Pregnancy, Visual/hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to improve cardiovascular health, so it's unlikely that medication changes are required.

Is the FAITH! App safe for use in humans?

The FAITH! App was pilot tested in a community setting to promote cardiovascular health among African Americans, but the study does not provide specific safety data. However, as a mobile health app, it is generally considered safe for use, focusing on lifestyle and wellness. ^{1 2 3 4 5}

How is the DHA-Enhanced FAITH! App treatment different from other treatments for cardiovascular disease?

The DHA-Enhanced FAITH! App is unique because it is a culturally tailored mobile health intervention specifically designed for African Americans, promoting cardiovascular health through community-based participation and lifestyle changes, unlike many other treatments that may not be culturally specific or community-focused. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment DHA-Enhanced FAITH! App for cardiovascular disease?

Research shows that mobile health apps can help manage cardiovascular disease by improving lifestyle behaviors, such as diet and exercise, and reducing risk factors like high blood pressure and cholesterol. Apps that provide personalized feedback and track healthy behaviors have been found to improve disease-specific knowledge and quality of life. ^{5 9 10 11 12}

Who Is on the Research Team?

LaPrincess C Brewer, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for African American adults with low digital health literacy, who own a smartphone and have limited fruit/vegetable intake and physical activity. They should be willing to use the FAITH! App to improve their cardiovascular health and participate in all study activities.

Inclusion Criteria

I am African American, over 18, and can use the Internet and email.

I am African American, over 18, own a smartphone, and have good digital health skills.

Exclusion Criteria

I can't walk up 2 flights of stairs or 1 city block without help or stopping.

Pregnant (at time of study enrollment)

I can use apps on my own without help, despite any visual, hearing, or mental challenges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-design and Training

Participants attend focus groups to co-design a digital health equity toolkit and train as Digital Health Advocates (DHAs)

8 weeks

Multiple focus group sessions

Randomized Controlled Trial

Participants use the FAITH! App, with some receiving additional support from DHAs, to improve cardiovascular health

12 months

Baseline, 3 months, 6 months, and 12 months assessments

Follow-up

Participants are monitored for changes in cardiovascular health and digital health readiness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DHA-Enhanced FAITH! App
• FAITH! App

Trial Overview The trial tests if the FAITH! App, especially when enhanced by Digital Health Advocates (DHAs), can improve cardiovascular health among African Americans. It involves co-designing a toolkit, training DHAs, and comparing app users with and without DHA support.

How Is the Trial Designed?

Group I: FAITH! App Experimental Treatment 1 Intervention

This group will use the FAITH! App on their own, with no DHA support.

Group II: DHA-Enhanced FAITH! App Experimental Treatment 1 Intervention

This group will use the FAITH! App with guided support from a Digital Health Advocate (DHA) within their church.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Association of Black Cardiologists

Collaborator

Trials

1

Recruited

200+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A review of 3078 mobile health applications (MHAs) for coronary heart disease (CHD) identified 38 that met quality criteria, revealing that most were affiliated with commercial companies and lacked scientific evidence to support their effectiveness.

The average quality rating of these MHAs was moderate (M = 3.38), with common features including information provision and risk calculators, but significant deficiencies in information quality and engagement were noted, highlighting the need for better-reviewed resources for patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Help in a Heartbeat?": A Systematic Evaluation of Mobile Health Applications (Apps) for Coronary Heart Disease. Mack, C., Terhorst, Y., Stephan, M., et al.[2021]

The study involving 60 participants with coronary artery disease showed that using a smartphone app for nutritional education significantly improved participants' Nutrition-Score compared to a control group, indicating better dietary adherence.

While the change in the Mediterranean diet score was not statistically significant, the TeleDiet group demonstrated a notable increase in nutrition knowledge, suggesting that digital solutions can enhance dietary education for patients with CAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of dietary education and counselling with a smartphone application on secondary prevention of coronary artery disease: A randomised controlled study (the TeleDiet study). Kaihara, T., Falter, M., Scherrenberg, M., et al.[2023]

Mobile applications for cardiovascular disease self-management have shown effectiveness in improving various health outcomes, such as reducing rehospitalization rates and enhancing quality of life among 607 patients across 10 studies.

Key features of successful apps included tracking healthy behaviors and personalized content, but the overall evidence quality was low, highlighting the need for larger, longer-term studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. Coorey, GM., Neubeck, L., Mulley, J., et al.[2022]

Mobile health (mHealth) is significantly advancing cardiovascular care through innovative strategies like SMS for smoking cessation and apps for monitoring health, showing promise in prevention and rehabilitation.

Despite the potential of mHealth, many apps lack regulation and evidence-based support, highlighting the need for robust systems to ensure safety and effectiveness in delivering healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. Chow, CK., Ariyarathna, N., Islam, SM., et al.[2022]

The MyHeartMate app, a game-based mobile intervention for coronary heart disease (CHD) patients, was well-accepted, with 94.8% of users engaging in tracking their health and activities, although it did not significantly improve overall physical activity levels compared to usual care.

The app did lead to a statistically significant reduction in triglyceride levels among users, indicating some efficacy in managing specific cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a game-based mobile app 'MyHeartMate' to promote lifestyle change in coronary disease patients: a randomized controlled trial. Gallagher, R., Chow, CK., Parker, H., et al.[2023]

The FAITH! App, designed specifically for African Americans, was well-received in a pilot study, with participants reporting high satisfaction and positive impacts on their cardiovascular health behaviors.

The app's effectiveness was attributed to its cultural tailoring and multimedia educational content, although participants suggested improvements like better self-monitoring features and personalized prompts to enhance user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-Going African Americans: Formative Evaluation of the FAITH! App. Brewer, LC., Kumbamu, A., Smith, C., et al.[2023]

A study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

The PortfolioDiet.app, designed to help manage dyslipidemia and prevent cardiovascular disease, was positively received by users, increasing their knowledge of the Portfolio Diet and influencing their food choices.

User testing led to significant improvements in the app's usability, achieving an average score of 85.39 on the System Usability Scale, indicating it is an effective educational tool for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Health Application to Translate Nutrition Therapy for Cardiovascular Risk Reduction in Primary Care (PortfolioDiet.app): Quality Improvement and Usability Testing Study. Kavanagh, ME., Chiavaroli, L., Glenn, AJ., et al.[2022]

A review of 55 smartphone apps promoting the Mediterranean diet found that while most apps provided useful features like recipes and meal plans, the overall quality was moderate with an average Mobile App Rating Scale (MARS) score of 2.84 out of 5.

The study highlighted that the apps generally included few behavioral change techniques (BCTs), averaging only 2.3 per app, suggesting that enhancing these techniques could improve user engagement and effectiveness in promoting adherence to the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Presence of Behaviour Change Techniques in Mobile Apps for the Mediterranean Diet: A Content Analysis of Android Google Play and Apple App Store Apps. McAleese, D., Linardakis, M., Papadaki, A.[2023]

The FAITH! App, a mobile health intervention, aims to improve cardiovascular health among African-Americans by promoting the American Heart Association's Life's Simple 7 (LS7) health behaviors, showing promise in addressing health inequities worsened by the COVID-19 pandemic.

In a study involving 85 participants, the trial demonstrated high feasibility with an 89% completion rate for baseline assessments, highlighting the potential of mHealth tools to engage communities and improve cardiovascular health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial. Brewer, LC., Jenkins, S., Hayes, SN., et al.[2023]

Digital health interventions (DHIs) showed an inconclusive effect on reducing cardiovascular disease (CVD) risk scores compared to usual care, based on a review of 6 randomized controlled trials involving 2,284 patients.

Among the different DHI modalities, automated email messaging appeared to be the most effective in improving CVD risk outcomes, although the overall evidence remains uncertain due to substantial variability in study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health RCT interventions for cardiovascular disease risk reduction: a systematic review and meta-analysis. Devani, RN., Kirubakaran, A., Molokhia, M.[2022]

The PreventS-MD web app was found to have excellent usability, with a mean System Usability Scale score of 81.7, indicating it is user-friendly for healthcare professionals (HCPs) managing stroke and cardiovascular disease (CVD) risk factors.

Patients using PreventS-MD reported 100% adherence to preventive recommendations after one month, demonstrating high satisfaction and motivation to follow the app's guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and feasibility of PreventS-MD web app for stroke prevention. Feigin, VL., Krishnamurthi, R., Medvedev, O., et al.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

"Help in a Heartbeat?": A Systematic Evaluation of Mobile Health Applications (Apps) for Coronary Heart Disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of dietary education and counselling with a smartphone application on secondary prevention of coronary artery disease: A randomised controlled study (the TeleDiet study). [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of a game-based mobile app 'MyHeartMate' to promote lifestyle change in coronary disease patients: a randomized controlled trial. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-Going African Americans: Formative Evaluation of the FAITH! App. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Health Application to Translate Nutrition Therapy for Cardiovascular Risk Reduction in Primary Care (PortfolioDiet.app): Quality Improvement and Usability Testing Study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Quality and Presence of Behaviour Change Techniques in Mobile Apps for the Mediterranean Diet: A Content Analysis of Android Google Play and Apple App Store Apps. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Digital health RCT interventions for cardiovascular disease risk reduction: a systematic review and meta-analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Usability and feasibility of PreventS-MD web app for stroke prevention. [2023]