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Completed

NCT Number: NCT03136588

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

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').

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Key information

Conditions

Kidney Transplantation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konyang University Hospital, Daejeon, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feedback using ICT based monitoring system

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Immunosuppressive drug levels

    Time frame: At every 4 weeks up to 24 weeks after enrollment

    Tacrolimus, Mycophenolic acid trough level

  2. Incidence of biopsy-proven acute rejection

    Time frame: Up to 24 weeks after enrollment

    Biopsy-proven acute rejection

  3. Development of de novo panel reactive antibody

    Time frame: Up to 24 weeks after enrollment

    De novo panel reactive antibody

  4. Development of polyomavirus (BK virus) infection

    Time frame: Up to 24 weeks after enrollment

    Polymerase chain reaction (PCR) of blood BK virus

  5. Changes in renal allograft function

    Time frame: From baseline to 24 weeks after enrollment

    Serum creatinine, estimated glomerular filtration rate

  6. 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

  7. Malfunction rate of ICT-based centralized monitoring system

    Time frame: Up to 24 weeks after enrollment

    Malfunction rate

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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