Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kid

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Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Selfmanagement among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol Denise Karin Beck1* , Mirjam Tielen1, Marloes Rechards1, Reinier Timman2, Charlotte Boonstra2, Josette Versteegh3, Jacqueline van de Wetering1, Robert Zietse1, Teun van Gelder1, Willem Weimar1, Jan van Saase1, Jan van Busschbach2 and Emma Kay Massey1

Abstract Background: After kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce. In this study we aim to develop and test an intervention to optimize adherence and selfmanagement. In this article we describe the background and design of the trial entitled ‘promoting Medication AdheRence and Self-management among kidney transplant recipients’ (MARS-trial)’. Methods/design: This is a single-center, parallel arm randomized controlled trial. Nonadherent kidney transplant recipients aged 12 years or older are eligible for inclusion. Patients will be randomly assigned to either the experimental or a control group. The control group will receive care-as-usual. The experimental group will receive care-as-usual plus the MARS-intervention. The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network. A standardized intervention protocol is used for consistency but we will tailor the behavior change techniques used to the specific needs and determinants of each patient. The primary outcome of medication adherence will be measured using electronic monitoring. Secondary outcome measures regarding medication adherence and self-management are also assessed. Data is collected at baseline (T0), after a run-in period (T1), at six months post-baseline/end of treatment (T2) and after a six month follow-up period (T3). (Continued on next page)

* Correspondence: [email protected] 1 Department of Internal Medicine – Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 Rotterdam, GD, Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not i