Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial

J Card Fail. 2019 Dec;25(12):948-958. doi: 10.1016/j.cardfail.2019.06.011. Epub 2019 Jul 2.

Abstract

Background: Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care.

Methods: Participants were randomized to the transition intervention (4 months long, focused on heart-transplant 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.

Results: Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups.

Conclusions: The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.

Keywords: Heart transplantation; Transition program.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Feasibility Studies
  • Female
  • Heart Failure / diagnosis*
  • Heart Failure / psychology
  • Heart Failure / therapy*
  • Heart Transplantation / methods*
  • Heart Transplantation / psychology
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Patient Transfer / methods*
  • Pilot Projects
  • Prospective Studies
  • Self Care / methods*
  • Self Care / psychology
  • Young Adult

Substances

  • Immunosuppressive Agents