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

ArmDescriptionAssigned 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

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center