Trials Today

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

Purpose

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

Condition

Heart Diseases

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Masking: None (Open Label)

Arm Groups

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

Recruiting Locations

University of Miami
Miami 4164138, Florida 4155751 33136

Contact:
Carolina Scaramutti, PhD
(305) 243-3797
cscaramutti@med.miami.edu

More Details

NCT ID: NCT06587204
Status: Recruiting
Sponsor: University of Miami

Study Contact

Carolina Scaramutti, PhD
305-243-1298
cscaramutti@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.