Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.
Department of Statistics, Kyungpook National University, Daegu, South Korea.
BMC Med Inform Decis Mak. 2020 Jun 10;20(1):105. doi: 10.1186/s12911-020-01146-6.
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. 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.
In 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.
Among 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).
Due 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.
ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.
先前的研究已经探讨了使用常规提醒来提高肾移植受者（KTR）的依从性，但没有研究包括关于药物剂量、频率和间隔的实时警报。在本研究中，我们旨在评估基于信息和通信技术（ICT）的集中监测系统在提高韩国 KTR 药物依从性方面的疗效和稳定性。
在这项前瞻性、多中心、随机对照研究中，入组的 KTR 被随机分配到基于 ICT 的集中监测组或对照组。如果漏服或剂量/时间错误，基于 ICT 的集中监测系统会通过短信和药盒警报提醒患者和医务人员。我们比较了两组在 6 个月内的药物依从性和移植结局，并评估了患者对基于 ICT 的监测系统的满意度。
在 114 名入组的 KTR 中，57 名被分配到基于 ICT 的集中监测组，57 名被分配到对照组。两组在每次随访时的平均依从率没有显著差异。他克莫司和霉酚酸的个体内变异水平、肾功能和不良移植结局在干预组和对照组之间，或在有反馈生成的干预组和无反馈生成的干预组之间没有差异。患者对基于 ICT 的集中监测系统的总体满意度很高，且在整个研究期间显著提高（p=0.012）。
由于基线依从性较高，基于 ICT 的集中监测系统未能最大限度地提高韩国 KTR 的药物依从性或增强移植结局。然而，患者对该系统非常满意。我们的结果表明，基于 ICT 的集中监测系统可以成功应用于临床试验。
ClinicalTrials.gov，NCT03136588。2017 年 4 月 20 日注册-回顾性注册。
