Heart Diseases
Conditions
Brief summary
The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .
Interventions
OTHERControl Group
Participants will receive standard of care.
BEHAVIORALDecentralized 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.
BEHAVIORALDigital 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.
BEHAVIORALSocial 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants adhering to the intervention | 3 months | Will be measured in percentage |
| Percentage of participants retained in the intervention | 3 months | Will be measured in percentage |
Countries
United States
Contacts
Primary ContactCarolina Scaramutti, PhD
Outcome results
None listed