Information and Communication Technology (ICT) Based Centralized Clinical Trial Monitoring System for Drug Adherence

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').

Conditions

• Kidney Transplantation

Interventions

DEVICE

Feedback using ICT based monitoring system

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.

Sponsors & Collaborators

• Ministry of Trade, Industry & Energy, Republic of Korea

  collaborator OTHER_GOV

• Korea Evaluation Institute of Industrial Technology

  collaborator OTHER

• Daegu Metropolitan City, Korea

  collaborator OTHER_GOV

• ICT Clinical Trial Coordination Center

  collaborator OTHER

• Kyungpook National University Hospital

  lead OTHER

Principal Investigators

• Yong-Lim KIM, MD, PhD · Kyungpook National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2018-08-23

Completion

2018-12-31

Countries

• South Korea

Study Locations