Kidney Transplantation Clinical Trial
Official title:
The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients
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').
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
1. to evaluate the effectiveness of ICT based centralized clinical trial monitoring system
on adherence of immunosuppressive agents
2. to study the influence of ICT based centralized monitoring on immunosuppressive and
clinical outcomes including therapeutic trough level
3. to evaluate patient's satisfaction about ICT based clinical trial monitoring system
;
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