Abstract
BackgroundImmunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative.Methods/designThis study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated.DiscussionThis on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs.Trials registrationClinicalTrials.gov, Identifier: NCT03136588. Registered on 20 April 2017.
Highlights
Immunosuppression non-adherence in kidney transplant recipients (KTRs) increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs
This on-going study is expected to determine if consistent use of the information and communication technology (ICT)-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs
It would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs
Summary
Immunosuppression non-adherence in kidney transplant recipients (KTRs) increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative. Given the multifaceted risk associated with immunosuppression non-adherence in KTRs, aggressive intervention by healthcare professionals to ensure adherence is imperative. Conventional ways of assessing drug adherence include blood drug level measurement, pill counts, patient interview/use of questionnaires, and electronic monitoring. Electronic monitoring has been regarded as the standard assessment of adherence [8] It keeps records of the date/time when patients open the pill box, and the computer-connected data is downloadable and analyzable. In a more recent randomized clinical trial, Reese et al have investigated KTRs who had been given pill bottles to demonstrate that the greatest adherence was achieved in those who received provider notification together with customized reminders [11]
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