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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRANSIT, behavioral | Experimental | The intervention group will receive more guidance during their transition from a pediatric center to the adult center |
|
| Usual Care Group | No Intervention | The usual care group will receive a standard transfer of care from a pediatric center to an adult center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRANSIT | Behavioral | Educational Modules, staff follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants. | Investigators hypothesize that by the end of the 3 month transition program and 6 months of follow-up, 84% of patients will be retained; 80% will participate in the program (module completion, discussion, and follow-up); and 100% will complete at least 80% of the survey instruments at each data collection point. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of TRANSIT on patient-level outcomes . | The following patient level outcomes will be measured:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elfriede Pahl, MD | Ann and Robert Lurie Children's Hospital | Principal Investigator |
| Kathleen Grady, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States | ||
| Universtiy of Colorado Denver/Children Colorado |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2019 | |
| Reset | Aug 8, 2019 | |
| Release | Mar 8, 2021 | |
| Reset | Apr 1, 2021 | |
| Release | Feb 11, 2025 | |
| Reset | Mar 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2019 | Aug 8, 2019 | |||
| Mar 8, 2021 |
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| 6 months |
| To determine the efficacy of TRANSIT on meso-level outcomes. | These will be measured based on the use of health care resources: rates of appointments for clinic and CNI blood draws and number of all-cause days re-hospitalized | 6 Months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Children's Hospital of Philadelphia/University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Apr 1, 2021 |
| Feb 11, 2025 | Mar 3, 2025 |