The TRANSNephro-study examining a new transition model for post-kidney transplant adolescents and an analysis of the present health care: study protocol for a randomized controlled trial.
Kreuzer M, Prufe J, et al.Trials 2014; 15: 505
Aims
To clarify whether a structured transition program with supplementary smartphone apps can improve the outcome of patients transitioning from paediatric to adult medicine.
Interventions
Patients will be randomized into two groups where an intervention group will receive case management by the Berliner TransitionsProgramm supported by a smartphone with two apps, compared to a control group who will be transferred according to the established protocols of the center.
Participants
Patients between 16-22 years of age who have undergone a kidney transplant
Outcomes
The primary outcome of the study is therapy adherence. Secondary outcomes are change in pre- and post-transfer eGFR, serum creatinine levels, transplant survival, patient survival, acute rejection reactions, transplant loss, death, patient satisfaction, healthcare utilization, and patients’ self-reported quality of life and social integration.
Follow-up
24 months
CET Conclusions
The TRANSNephro-study is directed at evaluating the most appropriate method of managing the transition of a paediatric transplant recipient into adult nephrology care. This is a major problem throughout the world in that more transplanted kidney are lost in patients aged between 16 and 21 years than in any other age group. In phase one of this trial, which is now in progress, they will be evaluating the standard current patient transition situation in all German paediatric and nephrology departments (n=17). Phase two will be a prospective randomised study in which they will compare current unstructured transition in the control group to structured transition in the intervention group. The transition approach integrates the core elements of the Berliner transitions programme in combination with two facilitating smart phone apps. The primary end point is to be compliance with therapy, while the secondary outcome will compare patients’ self-reported quality of life. The long term goal of this study is to provide a model of structured transition from paediatric to adult care for adolescent transplant recipients with the aim of improving graft survival as well as patient wellbeing.
Quality notes
Quality Assessment not appropriate
Trial registration
Clinicaltrials.gov - ISRCTN22988897