Improving digital participation among Black and non-White Hispanic adults with heart and metabolic conditions
Official title: Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
Run by University of Miami · NCT06587204 · Data updated 2026-11-12
This project will test whether decentralized, smartphone-based methods plus extra digital or social support help Black and non-White Hispanic adults with heart and cardiometabolic conditions stay enrolled and complete clinical research activities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 125 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06587204 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who identify as Black or non-White Hispanic, have pre-diabetes/diabetes or pre-hypertension/hypertension or other cardiometabolic risk factors, and own a smartphone are the intended participants.
✕Probably not a fit
People without smartphones, those who do not identify as Black or non-White Hispanic, or those without cardiometabolic conditions are unlikely to benefit from the specific interventions tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
UDECIDE randomizes eligible Black and non-White Hispanic adults with cardiometabolic conditions to a control arm or one of three remote engagement approaches: a decentralized arm, a digital literacy navigation arm, or a social care navigation arm. Participants must own a smartphone and have a history of pre-diabetes/diabetes and/or pre-hypertension/hypertension or related cardiometabolic risk factors. The study measures adherence and engagement with decentralized clinical activities to identify barriers and facilitators to participation. All enrollment and coordination are conducted through the University of Miami team.
Why it matters
Potential benefit: If successful, these approaches could increase enrollment and retention of underrepresented Black and Hispanic patients in cardiometabolic clinical research and improve equitable access to study-based resources.
How similar studies have gone: Some decentralized and digital-navigation programs have improved retention in other trials, but evidence specifically focused on underrepresented cardiometabolic populations is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Miami
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Azizi Seixas, PhD — University of Miami
- Study coordinator: Carolina Scaramutti, PhD
- Email: cscaramutti@med.miami.edu
- Phone: 305-243-1298
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.