NCT06587204

Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Heart Diseases

Interventions

Type	Name	Description
OTHER	Control Group	Participants will receive standard of care.
BEHAVIORAL	Decentralized Group	Participants will receive a one time digital lifestyle management program that will be used for the rest of the intervention. The Digital lifestyle management program is a virtual application that manages nutrition, exercise, and sleep. Participants will be using the application at least 1 hour each day.
BEHAVIORAL	Digital Literacy Navigation Group	Participants will receive a one time digital literacy training virtual learning digital health education for the rest of the intervention . The digital literacy training is a digital health education program that will be given 1 hour a day for 3 weeks.
BEHAVIORAL	Social Care Navigation Group	Participants will receive a one time social care navigation application that will be used for the rest of the intervention. The Social Care Navigation application is a digital application that provides social care resources in the community to participants. The application is used 1 hour a day, each day.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States