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Comparative Study
. 2020 Aug 28;21(1):374.
doi: 10.1186/s12882-020-02008-z.

Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol

Denise Karin Beck  1 , Mirjam Tielen  2 , Marloes Rechards  2 , Reinier Timman  3 , Charlotte Boonstra  3 , Josette Versteegh  4 , Jacqueline van de Wetering  2 , Robert Zietse  2 , Teun van Gelder  2 , Willem Weimar  2 , Jan van Saase  2 , Jan van Busschbach  3 , Emma Kay Massey  2
Affiliations
Comparative Study

Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol

Denise Karin Beck et al. BMC Nephrol. .

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 self-management. 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).

Discussion: We combined elements of (multi) systemic therapy and evidence-based behavior change techniques to create an outreaching and highly individualized intervention. In this trial we will investigate the impact on medication adherence and self-management after kidney transplantation.

Trial registration: Netherlands Trial Register,trial number NTR7462. Registered 7th September 2018, https://www.trialregister.nl/trial/7264.

Keywords: Adherence; Behavior change; Intervention; Kidney transplantation; Self-management.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of study procedures
See this image and copyright information in PMC

References

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