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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for heart disease?

Research shows that digital health interventions can improve health outcomes and healthcare access for people with cardiovascular disease, especially in diverse and underserved populations. These interventions have been effective in reducing hospital readmissions and improving adherence to treatment guidelines. ^{1 2 3 4 5}

Is the digital engagement treatment for heart disease safe for humans?

The research articles do not provide specific safety data for the digital engagement treatment, but they suggest that digital health interventions are generally used to improve health communication and medication adherence without mentioning any safety concerns. ^{1 3 5 6 7}

What makes the Digital Engagement for Heart Disease treatment unique?

The Digital Engagement for Heart Disease treatment is unique because it focuses on using digital tools like smartphone apps and virtual assistants to enhance patient self-management and communication with healthcare providers, which can improve health outcomes and reduce hospital readmissions. This approach is particularly beneficial for patients with low digital literacy, as it provides support and navigation to help them effectively use these technologies. ^{8 9 10 11 12}

What is the purpose of this trial?

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

Research Team

Azizi Seixas, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial Infarction. [2022]

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

Rapid review: Identification of digital health interventions in atherosclerotic-related cardiovascular disease populations to address racial, ethnic, and socioeconomic health disparities. [2022]

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

eHealth technology use and eHealth literacy after percutaneous coronary intervention. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Readability assessment of patient-provider electronic messages in a primary care setting. [2023]

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

Willingness of Patients to Use Computers for Health Communication and Monitoring Following Myocardial Infarction. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Effect of a health literacy intervention trial on knowledge about cardiovascular disease medications among Indigenous peoples in Australia, Canada and New Zealand. [2023]

8. Canada 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. [2020]

9. Netherlands 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. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Information Needs and Communication Strategies for People with Coronary Heart Disease: A Scoping Review. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an avatar educational application for improving heart failure patients' knowledge and self-care behaviors: A pragmatic randomized controlled trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor. [2020]