Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Pediatric Heart Transplantation: Transitioning to Adult Care|
- To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- To determine the efficacy of TRANSIT on patient-level outcomes . [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The following patient level outcomes will be measured:
- At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have lower CNI SD (i.e., SD <2.5 for tacrolimus and cyclosporine), than patients who receive usual care.
- At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have a higher percentage of CNI levels within the target range (i.e., < 50% of CNI blood levels out of target range for individual patients as reported by their transplant center), better self-reported adherence to the medical regimen, and fewer episodes of treated acute rejection, than patients who receive usual care.
- At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT then patients who receive usual care.
- To determine the efficacy of TRANSIT on meso-level outcomes. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]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
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: TRANSIT, behavioral
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
Educational Modules, staff follow up.
No Intervention: Usual Care Group
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02090257
|Contact: Elfriede Pahl, MDfirstname.lastname@example.org|
|Contact: Kathleen Grady, PhDemail@example.com|
|United States, California|
|Loma Linda University||Recruiting|
|Loma Linda, California, United States, 92354|
|Contact: Tamara Shankel, MD|
|United States, Colorado|
|Universtiy of Colorado Denver/Children Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: JoAnn Lindenfield, MD|
|Sub-Investigator: Shelly Miyamoto, MD|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Northwestern Memorial Hospital||Active, not recruiting|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Linda ADDONIZIO, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia/University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Debra Lefkowitz, MD|
|Principal Investigator: Lee Goldberg, MD|
|Principal Investigator:||Elfriede Pahl, MD||Ann and Robert Lurie Children's Hospital|
|Principal Investigator:||Kathleen Grady, PhD||Northwestern University|