Pediatric Heart Transplantation: Transitioning to Adult Care

Study Overview
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Brief Summary
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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.

Official Title
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Pediatric Heart Transplantation: Transitioning to Adult Care

Conditions
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Heart Transplantation

Intervention / Treatment
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* Behavioral: TRANSIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRANSIT, behavioral<br>The intervention group will receive more guidance during their transition from a pediatric center to the adult center | Behavioral: TRANSIT<br>* Educational Modules, staff follow up.<br>|
| No Intervention: Usual Care Group<br>The usual care group will receive a standard transfer of care from a pediatric center to an adult center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of TRANSIT on patient-level outcomes . | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplant recipients who are entering into adult care.