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

Not Applicable

Not yet recruiting

• Conditions: Heart Diseases
• Interventions: Other: Control Group; Behavioral: Decentralized Group; Behavioral: Digital Literacy Navigation Group; Behavioral: Social Care Navigation Group

• Registration Number: NCT06587204
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Study Start: 2025-09-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• History of pre-diabetes/diabetes and/or pre-hypertension/hypertension
• History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.
• Identify as Black or non-White Hispanic
• Own a smart phone

Exclusion Criteria

• Does not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	Participants in this group will be receiving the standard of care for up to 3 months.
Decentralized Group	Decentralized Group	Participants in this group will be receiving the decentralized intervention for up to 3 months.
Digital Literacy Navigation Group	Decentralized Group	Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.
Digital Literacy Navigation Group	Digital Literacy Navigation Group	Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.
Social Care Navigation Group	Decentralized Group	Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
Social Care Navigation Group	Digital Literacy Navigation Group	Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
Social Care Navigation Group	Social Care Navigation Group	Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.

Primary Outcome Measures

Name	Time	Method
Percentage of participants adhering to the intervention	3 months	Will be measured in percentage
Percentage of participants retained in the intervention	3 months	Will be measured in percentage

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States