Improving digital participation among Black and non-White Hispanic adults with heart and metabolic conditions
Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06587204 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Some decentralized and digital-navigation programs have improved retention in other trials, but evidence specifically focused on underrepresented cardiometabolic populations is limited.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.