Transplant Trial Watch

Nurse-Led Self-Management Support After Organ Transplantation - A Multicenter, Stepped-Wedge Randomized Controlled Trial.

van Zanten, R., et al.

Transplant International 2024; 37: 13175.


Aims
The aim of this study was to examine the effectiveness of the ZENN-intervention, a nurse-led self-management support intervention, targetted at promoting self-management skills in organ transplant recipients.

Interventions
Participants were randomised to receive either standard care combined with ZENN-intervention or standard care alone.

Participants
172 adult recipients of a heart, kidney, liver or lung transplant (>18 years old).

Outcomes
The primary endpoint was self-management. The secondary endpoints were self-regulation, quality of life, medication adherence, evaluation of experience, socio-demographic and medical characteristics, and intervention fidelty.

Follow-up
1 year posttransplantation

CET Conclusions
This randomised controlled trial aimed to assess whether the use of the nurse-led ZENN-intervention was able to enhance self-management skills of solid organ transplant recipients. Patients in the intervention group received standard care in addition to the ZENN- intervention, whereas the control group received standard care alone. Patients were given questionnaires to complete at baseline (T0), at six months (T1) and at 12 months follow-up (T2). Patients in the intervention group, who were found to have significantly lower self-management skills at baseline compared to the control group, showed significant improvements following the intervention. However, when between-group comparisons were made, no significant differences were observed between them in the primary or secondary outcomes at T1. Therefore, the authors concluded that transplant patients with low self-management skills may be able to benefit from this intervention. The study had a few limitations. Although, this trial was reported to be randomised, it appears that there may have been some selection bias present in the study as 1) the baseline Skills and Technique Acquisition (STA) scores were significantly different between the experiment and the control group, and 2) the number of patients in the intervention group were not sufficient resulting in an underpowered analysis for the experiment group, but not the control group. It is not clear from the paper on how the randomised sequence was generated or if the randomised allocation was adequately concealed.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
NL8469

Funding source
Industry funded