The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Drug adherence
研究概览
简要总结
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 cost. Aggressive preemptive effort by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is significant and imperative.
This study was designed as a prospective, randomized, controlled, and multicenter study aimed at evaluating efficacy and stability of the information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.
This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').
详细描述
This study has a multi-center, open-label, prospective, and randomized clinical trial design. One hundred KTRs who fill out the informed consent form are registered and randomized 1:1 into the ICT-based centralized clinical trial monitoring group (n=50) or the ambulatory follow-up group (n=50). The planned follow-up duration is 6 months. The ICT-based centralized clinical trial monitoring group is given a smart pill box equipped with personal identification system. Fingerprint registration is required in advance, so that it would be used for authentication before each use of the smart pill box later. The adherence-related information obtained from the pill box is saved, monitored, and sent out via a home-monitoring system. In the ICT-based centralized clinical trial monitoring group, feedback is sent to both patients and medical staff in the form of texts and pill box alarms if there is a dosage/dosing time error or a missed dose.
Both groups are to make 6 office visits after randomization at 4, 8, 12, 16, 20, and 24 weeks. Each visit requires measurement of blood drug level, creatinine level, and estimated glomerular filtration rate. Serum BK virus is assessed at 12 weeks, and panel reactive antibody at 24 weeks. Both groups keep a drug administration diary that specifies date, a dose taken or not, dosing time, and dosage. At each visit, subjects go over the diary with investigators and fill out a questionnaire using the Modified Morisky Scale. The ICT-based centralized clinical trial monitoring group completes a patient satisfaction questionnaire developed by the ICT clinical trial support center at 4 and 12 weeks.
The objective of this study is
- to evaluate the effectiveness of ICT based centralized clinical trial monitoring system on adherence of immunosuppressive agents
- to study the influence of ICT based centralized monitoring on immunosuppressive and clinical outcomes including therapeutic trough level
- to evaluate patient's satisfaction about ICT based clinical trial monitoring system
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 19 and over
- •At least 1 month lapsing from kidney transplantation
- •Stable renal function maintained after kidney transplantation(eGFR ≥ 30 mL/min/1.73m2)
- •History of kidney transplantation only and no other organs
- •Use of tacrolimus, mycophenolic acid, and steroids for post-transplant immunosuppression
- •Patients, with capability and willingness to give consent to trial participation, who have signed the informed consent form in compliance with due process and are capable of making office visits and taking part in the trial as required by the protocol.
排除标准
- •Patients' refusal of the ICT-based centralized home monitoring
- •History of treatment for acute rejection within the past 3 months
- •Active infectious disease
- •Uncorrected ischemic heart disease
- •Visual or auditory defects that could affect use of the smart pill box
- •Fingerprint authentication of personal identity deemed impossible (ex: adermatoglyphia)
- •Other reasons determined by investigators that make participation in the clinical trial inappropriate
结局指标
主要结局
Drug adherence
时间窗: at 6 months after enrollment
To evaluate the effectiveness of ICT based clinical trial monitoring system on the compliance of immunosuppressive medications.
次要结局
- Immunosuppressive drug levels(At every 4 weeks up to 24 weeks after enrollment)
- Incidence of biopsy-proven acute rejection(Up to 24 weeks after enrollment)
- Development of de novo panel reactive antibody(Up to 24 weeks after enrollment)
- Development of polyomavirus (BK virus) infection(Up to 24 weeks after enrollment)
- Changes in renal allograft function(From baseline to 24 weeks after enrollment)
- Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire(From 4 weeks to 24 weeks after enrollment)
- Malfunction rate of ICT-based centralized monitoring system(Up to 24 weeks after enrollment)
研究者
Yong-Lim Kim
Principal Investigator
Kyungpook National University Hospital