Pediatric Heart Transplantation: Transitioning to Adult Care
- Conditions
- Heart Transplantation
- Interventions
- Behavioral: TRANSIT
- Registration Number
- NCT02090257
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Have received a heart transplant at a children's hospital and are ready to transition, as determined by the pediatric heart transplant cardiologist, to the adult heart transplant center with whom a collaborative relationship has been established;
- 18 years or older;
- Able to speak, read at a fifth grade level or above, and write English;
- Physically able to participate.
- History of psychiatric hospitalization within the last 3 months, assessed on a case-by-case basis with exclusion only if patients could not potentially benefit from the intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TRANSIT, behavioral TRANSIT The intervention group will receive more guidance during their transition from a pediatric center to the adult center
- Primary Outcome Measures
Name Time Method To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants. 6 months 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.
- Secondary Outcome Measures
Name Time Method To determine the efficacy of TRANSIT on patient-level outcomes . 6 months The following patient level outcomes will be measured:
1. 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.
2. 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.
3. 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. 6 Months 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
Trial Locations
- Locations (6)
Universtiy of Colorado Denver/Children Colorado
🇺🇸Aurora, Colorado, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Columbia University
🇺🇸New York, New York, United States
Children's Hospital of Philadelphia/University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States