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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06587204
Status
Recruiting
Apply to this trial

Conditions

  • Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Control Group — OTHER
    Participants will receive standard of care.
  • Decentralized Group — BEHAVIORAL
    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.
  • Digital Literacy Navigation Group — BEHAVIORAL
    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.
  • Social Care Navigation Group — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Sep 15, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

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

Primary Outcome Measure

Percentage of participants adhering to the intervention [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Carolina Scaramutti, PhD
[email protected]
(305) 243-3797
Stacyca Dimanche, BS
[email protected]
(305) 243-3797
Azizi A Seixas, PhD (PRINCIPAL_INVESTIGATOR)
Carolina Scaramutti, PhD (SUB_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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