Abstract

BackgroundRecipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interventions are available to support post-transplant self-management. To fill this gap, we developed a self-management support intervention offered by nurse practitioners. The primary aim of the study is to implement and test the effectiveness of the ZENN intervention in promoting self-management skills among heart, kidney liver and lung transplant recipients in comparison to standard care. The secondary aim is to assess the self-management support skills of nurse practitioners who will deliver the intervention.MethodsThis multi-centre stepped-wedge randomized controlled trial will take place from September 2020 until May 2023. All departments will commence with inclusion of patients in the control period. Each department will be randomly assigned to a start date (step in the wedge) to commence the experimental period. Patients in the control period will receive standard care and will be asked to complete questionnaires at baseline (T0), 6 months (T1) and 12 months (T2), to assess self-management, self-regulation, quality of life and adherence. During the experimental period, patients will receive standard care plus the ZENN intervention and receive the same set of questionnaires as participants in the control period. Nurse practitioners will complete a baseline and follow-up questionnaire to assess differences in self-management support skills. Video recordings of outpatient clinic consultations during the control and experimental periods will determine the differences in nurses’ needs-thwarting and needs-supporting skills between the control and experimental period.DiscussionThe ZENN intervention could be a useful approach to support patients’ self-management skills after organ transplantation and thus promote clinical outcomes as well as avoid adverse events.Trial registrationDutch Trial Register NL8469. Registered on March 19, 2020.

Highlights

  • An organ transplantation is the preferred treatment for people with end-stage organ failure

  • Based on previous studies of our team [20, 22, 23], we developed a self-management intervention which is called the ZElfmanagement Na Niertransplantatie (ZENN; Dutch acronym for self-management after kidney transplantation) intervention [22]

  • The aims of the study are (1) to assess if the intervention has an effect on patients’ self-regulation and self-management skills, quality of life, medication adherence, coping and self-efficacy, controlling for socio-demographic and medical characteristics; (2) to assess if these changes are sustained over time after completion of the intervention; and (3) to test if the training and delivering the intervention has an effect on selfmanagement support skills among Nurse Practitioner (NP) who provide outpatient care after transplantation

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Summary

Introduction

An organ transplantation is the preferred treatment for people with end-stage organ failure. Patients need to deal with, for example, strict medication regimes, lifestyle changes and clinical appointments, social adjustment, and relationship instability [1,2,3,4,5,6,7,8,9]. They have to cope with psychological consequences of transplantation such as acceptance of the organ, feelings towards the donor and changes in roles and relationships [10, 11]. The secondary aim is to assess the self-management support skills of nurse practitioners who will deliver the intervention

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