Nurse-led self-management support after organ transplantation—protocol of a multicentre, stepped-wedge randomized controlled trial
On behalf of the aanZET study group
(2022) Trials, volume 23, issue 1, pp. 1 - 13
(Article)
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
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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.
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Keywords: Behaviour mechanisms, Goal, Holistic nursing, Motivation, Nurse practitioners, Patient participation, Psychotherapy, Self-control, Self-efficacy, Self-management, Nurse's Role, Humans, Self-Management, Organ Transplantation/adverse effects, Transplant Recipients, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Quality of Life, Pharmacology (medical), Medicine (miscellaneous), Journal Article
ISSN: 1745-6215
Publisher: BioMed Central
Note: Funding Information: The authors would like to thank their colleagues who gave feedback on the grant proposal and advised during the process of setting up the study protocol. Study group information The aanZET study group consists of: Erasmus University Medical Center, Rotterdam, The Netherlands: Denise Beck,?Marleen van Buren, Monique van Dijk, Marleen Goedendorp, Martijn van den Hoogen, Erwin Ista,?Marcia Kho, Louise Maasdam, Olivier Manintveld, Emma K. Massey, Marlies Reinders,?Joost van Rosmalen, Annelies de Weerd, Regina van Zanten, Robert Zietse University of Applied Science Rotterdam, Rotterdam, The Netherlands: Janet Been-Dahmen, AnneLoes van Staa University Centre for Nursing and Midwifery, Ghent University Hospital, Belgium: Ann Van Hecke Leiden University Medical Center, Leiden, The Netherlands: Jeannet Bisschop, Paul van der Boog,?Ruth Dam, Tessa van Diemen, Maaike Konijn, Esther Nijgh. Radboudumc, Nijmegen, The Netherlands: Marjo van Helden, Luuk Hilbrands University Medical Center Groningen, Groningen, The Netherlands: Coby Annema, Lyda Engelsman, Tally Norder, Christina Oosterhoff, Irma Saro, Geesje Smeenge University Medical Center Utrecht, Utrecht, The Netherlands: Sanne Bosman, Esther de Haan, Anja Kooistra,?Arjan van Zuilen Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)
