NCT03136588

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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').

Detailed description

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

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-23
• Completion: 2018-12-31
• First posted: 2017-05-02
• Last updated: 2020-09-07

Locations

2 sites across 1 country: South Korea