CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Feedback using ICT based monitoring systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03136588
NCT03136588N/ACompleted
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The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients

Kyungpook National University Hospital·interventional·Posted May 2, 2017·Updated Sep 7, 2020

In Brief

A clinical study evaluating Feedback using ICT based monitoring system for Kidney Transplantation. Completed, enrolled 114 participants across 2 sites.

Detailed Summary

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').

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesSouth Korea
CollaboratorsMinistry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2017
Enrollment StartJan 1, 2017
Primary CompletionAug 23, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.2 years ago

Interventions

Feedback using ICT based monitoring systemdevice

In case of a missed immunosuppressant dose, the first violation does not generate a feedback while the second one does within one hour at the break of the ±3 hour range from the fixed dosing time. Up to two additional alarms/texts are sent at an interval of 30 minutes if the dose is still not taken after the feedback. For any discrepancy between the dosage taken and the dosage prescribed, a feedback is sent within 1 hour from the moment of recognition. Again, the first violation goes without response, while any violation after that generates feedbacks. Similarly, if a dose is taken outside of the allowed ±3 hour dosing time range, a feedback is sent within 1 hour of recognition, starting with the second violation.