Digital Engagement for Heart Disease

Overseen By Carolina Scaramutti, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Does not meet inclusion criteria

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well individuals with heart-related conditions can adhere to using digital healthcare tools. The focus is on those with conditions such as diabetes or high blood pressure, who are often underrepresented in research. Participants will explore various methods, including digital assistance and social support, to determine which is most effective for maintaining engagement with online healthcare services. The trial seeks Black or non-White Hispanic individuals who own a smartphone and have experienced conditions like heart disease or diabetes. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance digital healthcare engagement for underrepresented communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers closely monitored decentralized clinical trials to ensure safety. An independent committee identified any problems and ensured the trial ran smoothly, demonstrating that safety is a top priority. Research into digital health education programs has also shown good results. Participants gained important skills and knowledge, with no serious safety issues reported.

For social care guidance, studies have shown that using patient navigators (individuals who assist with healthcare decisions) can reduce risks related to heart disease. This method has been successful with no major safety problems. Overall, these treatments appear well-tolerated, with no significant negative effects reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Digital Engagement for Heart Disease" trial because it explores innovative ways to support heart disease patients using digital tools and social support. Unlike traditional treatments that focus mainly on medication and lifestyle changes, this trial investigates three unique approaches: decentralized interventions, digital literacy navigation, and social care navigation. The decentralized group aims to provide flexible, remote support, which could make managing heart disease more accessible for patients. The digital literacy navigation group focuses on improving patients' ability to use digital health resources, potentially empowering them with better tools to manage their condition. Lastly, the social care navigation group offers guidance on accessing social support services, which could enhance overall well-being and health outcomes. These approaches are exciting as they could complement existing treatments by addressing the broader lifestyle and social factors affecting heart disease management.

What evidence suggests that this trial's treatments could be effective for heart disease?

This trial will compare different digital engagement strategies for heart disease. Research has shown that healthcare strategies outside traditional settings can help people adhere to their heart treatment plans. Participants in the Decentralized Group will receive interventions using digital tools, like health apps, which studies have found can significantly improve health outcomes for heart disease patients, reducing the risk of death and illness. The Digital Literacy Navigation Group will focus on programs that teach technology use, which can enhance care and lead to better heart health over time. Meanwhile, the Social Care Navigation Group will explore support systems, such as patient guides, which evidence suggests can increase awareness and management of heart disease. These methods aim to make healthcare more accessible and effective, especially for those who might not usually receive the care they need. ^{2 5 6 7 8}

Who Is on the Research Team?

Azizi Seixas, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

The UDECIDE study is for underrepresented groups with poor cardiovascular and cardiometabolic health. Specific eligibility criteria are not provided, but typically participants would need to have a relevant condition and meet certain health standards.

Inclusion Criteria

I have a history of pre-diabetes, diabetes, pre-hypertension, or hypertension.

Identify as Black or non-White Hispanic

I have a history of heart or blood vessel problems, diabetes, or high cholesterol.

Exclusion Criteria

Does not meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Social Care Navigation, Decentralized intervention, Digital Literacy Navigation, or standard care for up to 3 months

3 months

Follow-up

Participants are monitored for adherence and retention in the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decentralized Group
• Digital Literacy Navigation Group
• Social Care Navigation Group

Trial Overview This trial tests how well different groups stick to decentralized clinical trials. There's a control group, one that uses digital tools, another that gets help understanding these tools, and one that receives social care support.

How Is the Trial Designed?

Group I: Social Care Navigation Group Experimental Treatment 3 Interventions

Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.

Group II: Digital Literacy Navigation Group Experimental Treatment 2 Interventions

Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.

Group III: Decentralized Group Experimental Treatment 1 Intervention

Participants in this group will be receiving the decentralized intervention for up to 3 months.

Group IV: Control Group Experimental Treatment 1 Intervention

Participants in this group will be receiving the standard of care for up to 3 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The iHeartU mobile health app was developed to enhance self-management for heart failure patients, aiming to improve communication with healthcare providers and reduce hospital readmission rates.

Initial usability testing is underway, and the app is designed to be user-friendly and accessible, particularly for low-income patients, potentially leading to better health outcomes and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study. Zhang, L., Babu, SV., Jindal, M., et al.[2020]

Effective management of coronary heart disease (CHD) requires personalized, evidence-based education and support that considers individual patient needs and preferences, as highlighted by a scoping review of literature from 2000 to 2022.

Digital health strategies, such as text messaging programs and smartphone applications, can enhance patient education and support, but a flexible approach is necessary since there is no single method that works for all patients at every stage of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information Needs and Communication Strategies for People with Coronary Heart Disease: A Scoping Review. Zwack, CC., Smith, C., Poulsen, V., et al.[2023]

An interactive digital e-health game (IDEG) was developed to improve self-management in older patients with heart failure, which is crucial since effective self-management can reduce hospitalizations by up to 50%.

Usability testing showed that 5 out of 6 participants found the game interesting, enjoyable, and helpful, indicating that such digital tools can be both feasible and acceptable for older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Older Adults with Heart Failure on Playing an Interactive Digital e-Health Game (IDEG) for Learning About Heart Failure (HF): Prototype Development and Usability Testing. Radhakrishnan, K., Toprac, P., O'Hair, M., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12088620/

Augmenting Engagement in Decentralized Clinical Trials ... The trials shared the primary outcome to improve adherence to oral anticoagulation for thromboembolic stroke prevention in individuals with AF, ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027899

Internet Versus Noninternet Participation in a ... We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial.

3. globalheartjournal.com globalheartjournal.com/articles/10.5334/gh.1313

Decentralization and Integration of Advanced Cardiac Care ... PEN-Plus is strategy to decentralized advanced cardiac care as part of an integrated management strategy for severe chronic noncommunicable diseases (NCDs).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282376/

Effects of a digitally enabled cardiac rehabilitation ... The DeCR group had significant improvements in most risk factors. Rehospitalization and mortality rates were similar between the DeCR group and both comparison ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06587204

Understanding Decentralized Trial Engagement and ... The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10976983/

Decentralization and Integration of Advanced Cardiac Care for ... We describe how PEN-Plus addresses the need for advanced cardiac care and discuss how a global group of cardiac organizations are working ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001048252500962X

Blockchain-aided comparative study of heart disease ... Recognizing these challenges, this study analyzes medical data and explores advanced technologies to unravel the potential of machine learning and blockchain in ...

8. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70328

Decentralized Clinical Trials in the Era of Real‐World ... An independent Data Monitoring Committee was set up to monitor both efficacy, safety outcomes and can make recommendations regarding study ...