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NCT Number: NCT06587204

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

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

Recruiting

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of participants adhering to the intervention

    Time frame: 3 months

    Will be measured in percentage

  2. Percentage of participants retained in the intervention

    Time frame: 3 months

    Will be measured in percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Scaramutti, PhD

CONTACT

[email protected]

305-243-1298

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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