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

September 3, 2020 updated by: Yong-Lim Kim, Kyungpook National University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Konyang University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICT based monitoring group
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
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.
No Intervention: Control group
Use standard questionnaire to gather information for drug adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug adherence
Time Frame: at 6 months after enrollment
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
Time Frame: At every 4 weeks up to 24 weeks after enrollment
Tacrolimus, Mycophenolic acid trough level
At every 4 weeks up to 24 weeks after enrollment
Incidence of biopsy-proven acute rejection
Time Frame: Up to 24 weeks after enrollment
Biopsy-proven acute rejection
Up to 24 weeks after enrollment
Development of de novo panel reactive antibody
Time Frame: Up to 24 weeks after enrollment
De novo panel reactive antibody
Up to 24 weeks after enrollment
Development of polyomavirus (BK virus) infection
Time Frame: Up to 24 weeks after enrollment
Polymerase chain reaction (PCR) of blood BK virus
Up to 24 weeks after enrollment
Changes in renal allograft function
Time Frame: From baseline to 24 weeks after enrollment
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
Time Frame: From 4 weeks to 24 weeks after enrollment
System satisfaction questionnaire score
From 4 weeks to 24 weeks after enrollment
Malfunction rate of ICT-based centralized monitoring system
Time Frame: Up to 24 weeks after enrollment
Malfunction rate
Up to 24 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Yong-Lim KIM, MD, PhD, Kyungpook National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICT_COM_P01_KT-ver2.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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