Digital Engagement for Heart Disease
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.12345Why 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.25678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Social Care Navigation, Decentralized intervention, Digital Literacy Navigation, or standard care for up to 3 months
Follow-up
Participants are monitored for adherence and retention in the intervention
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?
4
Treatment groups
Experimental Treatment
Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.
Participants in this group will be receiving the decentralized intervention for up to 3 months.
Participants in this group will be receiving the standard of care for up to 3 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Published Research Related to This Trial
Citations
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, ...
Internet Versus Noninternet Participation in a ...
We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial.
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).
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 ...
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 .
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 ...
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 ...
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 ...
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