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Completed

NCT Number: NCT02090257

Pediatric Heart Transplantation: Transitioning to Adult Care

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.

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRANSIT

Behavioral

Educational Modules, staff follow up.

Primary outcomes

  1. Number of Participants Adhering With the Transition Program

    Time frame: 6 months post transition follow-up

    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).

Secondary outcomes

  1. Tacrolimus Levels

    Time frame: 6 months post transition follow-up

    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(calcineurin inhibitor) SD (standard deviation) (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.

  2. Meso-level Outcomes.

    Time frame: 6 Months post transition follow-up

    The 3 meso level outcomes which were measured are the following (clinical appointment adherence and re-hospitalization). These are measured through

    • # of participants with clinic attendance through 6 months post transition follow up
    • # of participants with appointment adherence for CNI (calcineurin inhibitor= tacro and cyclosporine) blood draws through 6 months post transition follow up
    • # of participants with all-cause re-hospitalizations through 6 months post transition follow up

  3. Percentage of Subjects Reaching a Targeted Tacrolimus Level

    Time frame: at 6 months post transition followup

    Percentage of subjects in each group who met target tacro level

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: TRANSIT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 18, 2014
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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