Pediatric Heart Transplantation: Transitioning to Adult Care

N/ACompletedNCT02090257

Ann & Robert H Lurie Children's Hospital of Chicago88 enrolled

Overview

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.

Young adult heart transplant (HT) recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine feasibility and test a transition intervention for young adults who underwent HT as children and transferred to adult care. Participants were randomized to the transition intervention (4 months long, focused on HT knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Heart Transplantation

Interventions

TRANSITBEHAVIORAL

Educational Modules, staff follow up.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Loma Linda University

Loma Linda, California, United States

Universtiy of Colorado Denver/Children Colorado

Aurora, Colorado, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants Adhering With the Transition Program

Investigators hypothesize that by the end of the 3 month transition program, subjects will be assessed and retained through 6 months of follow-up, and 84% of patients will be retained with 6 month follow-up reported and 80% will participate in the program to full completion (module completion, discussion, and follow-up).

Time frame: 6 months post transition follow-up

Secondary Outcomes

Tacrolimus Levels

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(calcineurin inhibitor) SD (standard deviation) (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.

Time frame: 6 months post transition follow-up

Meso-level Outcomes.

The 3 meso level outcomes which were measured are the following (clinical appointment adherence and re-hospitalization). These are measured through 1. \# of participants with clinic attendance through 6 months post transition follow up 2. \# of participants with appointment adherence for CNI (calcineurin inhibitor= tacro and cyclosporine) blood draws through 6 months post transition follow up 3. \# of participants with all-cause re-hospitalizations through 6 months post transition follow up

Time frame: 6 Months post transition follow-up

Percentage of Subjects Reaching a Targeted Tacrolimus Level

Percentage of subjects in each group who met target tacro level

Data from ClinicalTrials.gov

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