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首页> 外文期刊>Trials >The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial
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The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial

机译：肾移植受者中基于信息和通信技术的免疫抑制药物依从性集中监控系统的有效性和稳定性：一项随机对照试验的研究方案

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Background Immunosuppression 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/design This 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. Discussion This 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 registration ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017.
机译：背景技术肾移植受者（KTR）的免疫抑制非依从性不仅会由于急性排斥反应和移植物丢失而增加医疗干预的风险，而且会以医疗成本增加的形式给社会经济体系带来负担。医疗保健专业人员采取积极的先发制人的努力，对于确保遵守KTR中的免疫抑制剂具有重要意义，势在必行。方法/设计本研究是一项前瞻性，开放标签，多中心，随机对照研究，旨在评估基于信息和通信技术（ICT）的集中监控系统在提高KTR药物依从性方面的功效和稳定性。在2017年至2018年期间注册的114个KTR，被随机分为基于ICT的集中式家庭监控系统或动态随访。计划的随访时间为6个月。所描述的基于ICT的集中式家庭监控系统由配备个人识别系统的智能药盒，家庭监控系统，电子病例报告表（eCRF）系统和综合临床试验管理系统（CTMS）组成。如果出现剂量/给药时间错误或错过剂量，它会通过文本和药盒警报向患者和医护人员发出警报。在两组之间比较随访期间的药物依从性和移植结果，同时将评估患者满意度以及基于ICT的监测系统的稳定性和成本效益。讨论预期这项正在进行的研究将确定一致使用所述基于ICT的集中监控系统是否可以最大程度地提高调解依从性，并随后提高KTR中的移植效果。此外，这将为成功实施基于信息通信技术的监测系统奠定基础，以有效管理KTR中的药物依从性。试验注册ClinicalTrials.gov，标识符：NCT03136588。 2017年4月20日注册。

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