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.

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

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.

Time frame: 6 months

Secondary Outcomes

To determine the efficacy of TRANSIT on patient-level outcomes .

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.

Time frame: 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

Time frame: 6 Months

Data from ClinicalTrials.gov

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