Abstract
BackgroundPrior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs.MethodsIn this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6 months, and evaluated patient satisfaction with the ICT-based monitoring system.ResultsAmong 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p = 0.012).ConclusionsDue to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials.Trial registrationClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.
Highlights
Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval
Among kidney transplant recipients (KTRs), nonadherence to immunosuppressive medications is a major cause of antibody-mediated rejection, which leads to graft loss [1, 2]
In this randomized clinical trial, we found that Korean KTRs already showed high adherence in terms of dosing and timing
Summary
Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. We aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs. Among kidney transplant recipients (KTRs), nonadherence to immunosuppressive medications is a major cause of antibody-mediated rejection, which leads to graft loss [1, 2]. We hypothesized that unintentional forgetfulness regarding immunosuppressive medications in KTRs could be improved by continuous electronic monitoring of adherence, and by providing patients with reminder alarms from the information and communication technology (ICT)-based centralized monitoring system. The main methodologic difference in our present study is that we provided real-time alarms about both drug dose and interval, and used a smart pill box to determine adherence, including dose-taking adherence, dose-frequency adherence, frequency, and dose-interval adherence
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