Nurse-led self-management support after organ transplantation—protocol of a multicentre, stepped-wedge randomized controlled trial

Regina van Zanten*, Monique van Dijk, On behalf of the aanZET study group, Joost van Rosmalen, Denise Beck, Robert Zietse, Ann Van Hecke, Anne Loes van Staa, Emma K. Massey

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: Recipients 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. Methods: This 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. Discussion: The 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 registration: Dutch Trial Register NL8469. Registered on March 19, 2020.

Original languageEnglish
Article number14
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - 6 Jan 2022

Bibliographical note

Funding Information:
This is an investigator-initiated study funded by Chiesi Pharmaceuticals B.V. the Netherlands, as the local representative of the marketing authorisation holder Chiesi Farmaceutici S.p.A. of LCPT. The funding body will not play any role in the design of the study, data collection, analysis or interpretation of the data, or writing of the manuscript.

Publisher Copyright:
© 2022, The Author(s).

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