Transplant Trial Watch

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

Grady, K. L., et al.

Journal of Cardiac Failure 2019; 25 (12): 948-958


Aims
The examine the feasiblity of a transition intervention for young adult, heart transplant recipients who were transferred to adult care.

Interventions
Participants were randomly assigned to either the transition intervention group or the usual care group.

Participants
88 young adult, heart transplant recipients aged >18 years

Outcomes
Knowledge of heart transplantation, readiness to transition to adult care, social support, patient level adherence to medical regimen, bio-assays for tacrolimus and cyclosporine, adverse events and health care utilisation.

Follow-up
6 months

CET Conclusions
This pilot, multicentre randomised controlled trial tested the feasibility of a transition intervention (TRANSIT) for young adult heart transplant recipients (> 18 years) transferred to adult care. The 4-month intervention was focussed on increasing knowledge, self-care and self-efficacy skills and enhancing social support, and was compared with usual care. The report did not include any details regarding the randomisation and whether allocation to groups was concealed. Eighty-eight participants were included in the study and overall retention and participation rates were higher than expected. There were no significant differences between groups for knowledge, satisfaction with support, and self-advocacy and self-care skills. Mean tacrolimus levels did not differ between groups at 6 months. There were also no differences between groups for self-reported adherence, number of adverse events and rate of appointment keeping and rehospitalisation. The authors discuss a few study limitations and suggest that the study results provide guidance for future trials.

Jadad score
2

Data analysis
Available case analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT02090257

Funding source
Non-industry funded