Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial

INTRODUCTION: Adherence to a complex and ongoing set of therapeutic recommendations significantly determines short and long-term outcomes after kidney transplantation (KT). Interactive voice response system (IVRS) is a novel phone-based platform which is potentially useful to deliver health behavior interventions. OBJECTIVE: The aims of the study is to describe the development of a theory-driven and educational IVRS investigate the effect of an IVRS on the self-management outcomes in KT recipients as compared with the control group. METHODS: This study has been designed as a randomized, 2 parallel groups controlled trial. The KT recipients’ older than18 years of age with access to a cellphone will be included. A total of 120 patients will be randomly assigned to the control and intervention groups. The participants in the intervention group will receive completely automatic calls in 3 categories: educational, medication adherence, and reminders by the IVRS, whereas those in the control group will receive usual care. The follow up will be performed within 6 months. The primary outcome will be the medication adherence while patients’ transplant knowledge, health-related quality of life, and rehospitalization rates will be considered as secondary outcomes. RESULTS: Thus far, recruitment of participants has not been completed and results will be published in 2019. DISCUSSION: The IVRS is potentially useful to help KT recipients improve the self-management outcomes. The hypothesis is using an IVRS intervention makes a significant difference between basel assessment of adherence to immunosuppressive medications scale, 12-item short form survey, second version, kidney transplant understanding tool baseline scores, and those obtained at the end of study. TRIAL REGISTRATION NUMBER: This trial is registered with the Iran Trial Registrar under registration number IRCT20180124038492N1 and registration date 30 January 2018. https://irct.ir/trial/29215