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The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Participants in this group will be receiving the standard of care for up to 3 months. |
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| Decentralized Group | Experimental | Participants in this group will be receiving the decentralized intervention for up to 3 months. |
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| Digital Literacy Navigation Group | Experimental | Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months. |
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| Social Care Navigation Group | Experimental | Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Other | Participants will receive standard of care. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants adhering to the intervention | Will be measured in percentage | 3 months |
| Percentage of participants retained in the intervention | Will be measured in percentage | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Scaramutti, PhD | Contact | 305-243-1298 | cscaramutti@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Azizi Seixas, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| 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. |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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