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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Device: Feedback using ICT based monitoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized in a 1:1 ratio to either Information and Communication Technology (ICT) based centralized clinical trial monitoring system or control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICT based monitoring group<br>Intervention: In the ICT-based centralized monitoring group, both subjects and medical staff receive feedbacks regarding a missed dose, misuse, and overuse of the medication in the form of text messages and pill box alarms. | Device: Feedback using ICT based monitoring system<br>* 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.<br>|
| No Intervention: Control group<br>Use standard questionnaire to gather information for drug adherence | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug adherence | To evaluate the effectiveness of ICT based clinical trial monitoring system on the compliance of immunosuppressive medications. | at 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunosuppressive drug levels | Tacrolimus, Mycophenolic acid trough level | At every 4 weeks up to 24 weeks after enrollment | 
| Incidence of biopsy-proven acute rejection | Biopsy-proven acute rejection | Up to 24 weeks after enrollment | 
| Development of de novo panel reactive antibody | De novo panel reactive antibody | Up to 24 weeks after enrollment | 
| Development of polyomavirus (BK virus) infection | Polymerase chain reaction (PCR) of blood BK virus | Up to 24 weeks after enrollment | 
| Changes in renal allograft function | Serum creatinine, estimated glomerular filtration rate | From baseline to 24 weeks after enrollment | 
| Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire | System satisfaction questionnaire score | From 4 weeks to 24 weeks after enrollment | 
| Malfunction rate of ICT-based centralized monitoring system | Malfunction rate | Up to 24 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Information and Communication Technology, Kidney transplantation, Adherence