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

University of Miami

Status: Begins enrollment in 1 month

Conditions: Heart Diseases

Treatments: Other: Control Group; Behavioral: Decentralized Group; Behavioral: Social Care Navigation Group; Behavioral: Digital Literacy Navigation Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06587204

20240230

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 4 patient groups

Control Group

Other group

Description:

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

Treatment:

Other: Control Group

Decentralized Group

Experimental group

Description:

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

Treatment:

Behavioral: Decentralized Group

Digital Literacy Navigation Group

Experimental group

Description:

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

Treatment:

Behavioral: Digital Literacy Navigation Group

Behavioral: Decentralized Group

Social Care Navigation Group

Experimental group

Description:

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

Treatment:

Behavioral: Digital Literacy Navigation Group

Behavioral: Social Care Navigation Group

Behavioral: Decentralized Group