Recruiting NCT06587204
Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control Group, Decentralized Group, Digital Literacy Navigation Group, Social Care Navigation Group.
- Who it may be relevant to
- Registry conditions: Heart Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .
Interventions
- Other Control Group
Participants will receive standard of care. - Behavioral Decentralized 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. - Behavioral Digital 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. - Behavioral Social 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.
Primary outcome measures
- Percentage of participants adhering to the intervention [Time frame: 3 months]
- Percentage of participants retained in the intervention [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06587204 · 20240230