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

Sponsors

Lead Sponsor: Kyungpook National University Hospital

Collaborator: Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center

Source Kyungpook National University Hospital
Brief 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

Overall Status Completed
Start Date 2017-01-01
Completion Date 2018-12-31
Primary Completion Date 2018-08-23
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Drug adherence at 6 months after enrollment
Secondary Outcome
Measure Time Frame
Immunosuppressive drug levels At every 4 weeks up to 24 weeks after enrollment
Incidence of biopsy-proven acute rejection Up to 24 weeks after enrollment
Development of de novo panel reactive antibody Up to 24 weeks after enrollment
Development of polyomavirus (BK virus) infection Up to 24 weeks after enrollment
Changes in renal allograft function From baseline to 24 weeks after enrollment
Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire From 4 weeks to 24 weeks after enrollment
Malfunction rate of ICT-based centralized monitoring system Up to 24 weeks after enrollment
Enrollment 114
Condition
Intervention

Intervention Type: Device

Intervention Name: Feedback using ICT based monitoring system

Description: 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.

Arm Group Label: ICT based monitoring group

Eligibility

Criteria:

Inclusion Criteria: 1. Men and women aged 19 and over 2. At least 1 month lapsing from kidney transplantation 3. Stable renal function maintained after kidney transplantation(eGFR ≥ 30 mL/min/1.73m2) 4. History of kidney transplantation only and no other organs 5. Use of tacrolimus, mycophenolic acid, and steroids for post-transplant immunosuppression 6. 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: 1. Patients' refusal of the ICT-based centralized home monitoring 2. History of treatment for acute rejection within the past 3 months 3. Active infectious disease 4. Uncorrected ischemic heart disease 5. Visual or auditory defects that could affect use of the smart pill box 6. Fingerprint authentication of personal identity deemed impossible (ex: adermatoglyphia) 7. Other reasons determined by investigators that make participation in the clinical trial inappropriate

Gender:

All

Minimum Age:

19 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yong-Lim KIM, MD, PhD Principal Investigator Kyungpook National University Hospital
Location
Facility:
Konyang University Hospital | Daejeon, Korea, Republic of
Ulsan University Hospital | Ulsan, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kyungpook National University Hospital

Investigator Full Name: Yong-Lim Kim

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: ICT based monitoring group

Type: Experimental

Description: 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.

Label: Control group

Type: No Intervention

Description: Use standard questionnaire to gather information for drug adherence

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: randomized in a 1:1 ratio to either Information and Communication Technology (ICT) based centralized clinical trial monitoring system or control group

Primary Purpose: Treatment

Masking: None (Open Label)

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