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Kidney TransplantationNCT03136588

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

A study testing Feedback using ICT based monitoring system in people with Kidney Transplantation, run by Kyungpook National University Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Feedback using ICT based monitoring system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
2 sitesSouth Korea
Study dates
Jan 2017to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Konyang University Hospital

    Daejeon

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official 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

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').

Read the 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
Being tested
Feedback using ICT based monitoring system
Keywords
Information and Communication Technology, Adherence, Kidney transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feedback using ICT based monitoring systemDevice

    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.

Study groups in NCT03136588
Study groupRoleWhat they receive
ICT based monitoring groupExperimentalIntervention: 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.
Receives: Device: Feedback using ICT based monitoring system
Control groupNo interventionUse standard questionnaire to gather information for drug adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug adherence

    To evaluate the effectiveness of ICT based clinical trial monitoring system on the compliance of immunosuppressive medications.

    Measured: at 6 months after enrollment

Secondary outcomes (7)

  1. Immunosuppressive drug levels

    Tacrolimus, Mycophenolic acid trough level

    Measured: At every 4 weeks up to 24 weeks after enrollment

  2. Incidence of biopsy-proven acute rejection

    Biopsy-proven acute rejection

    Measured: Up to 24 weeks after enrollment

  3. Development of de novo panel reactive antibody

    De novo panel reactive antibody

    Measured: Up to 24 weeks after enrollment

  4. Development of polyomavirus (BK virus) infection

    Polymerase chain reaction (PCR) of blood BK virus

    Measured: Up to 24 weeks after enrollment

  5. Changes in renal allograft function

    Serum creatinine, estimated glomerular filtration rate

    Measured: From baseline to 24 weeks after enrollment

  6. Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire

    System satisfaction questionnaire score

    Measured: From 4 weeks to 24 weeks after enrollment

  7. Malfunction rate of ICT-based centralized monitoring system

    Malfunction rate

    Measured: Up to 24 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2017
  2. Study startJan 2017
  3. Primary completion23 Aug 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03136588
Sponsor's protocol ID
ICT_COM_P01_KT-ver2.4
Status last verified
Sep 2020
First submitted
20 Apr 2017
Last updated
7 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 Feb;12(2):388-99. doi: 10.1111/j.1600-6143.2011.03840.x. Epub 2011 Nov 14.

    PubMed 22081892

  • Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x.

    PubMed 19843035

  • Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant. 2008 Mar;8(3):616-26. doi: 10.1111/j.1600-6143.2007.02127.x.

    PubMed 18294158

  • Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296-310. doi: 10.1016/s0149-2918(01)80109-0.

    PubMed 11558866

  • Henriksson J, Tyden G, Hoijer J, Wadstrom J. A Prospective Randomized Trial on the Effect of Using an Electronic Monitoring Drug Dispensing Device to Improve Adherence and Compliance. Transplantation. 2016 Jan;100(1):203-9. doi: 10.1097/TP.0000000000000971.

    PubMed 26588006

  • Christensen A, Christrup LL, Fabricius PE, Chrostowska M, Wronka M, Narkiewicz K, Hansen EH. The impact of an electronic monitoring and reminder device on patient compliance with antihypertensive therapy: a randomized controlled trial. J Hypertens. 2010 Jan;28(1):194-200. doi: 10.1097/HJH.0b013e328331b718.

    PubMed 19770778

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PubMed 36094829

  • Jung HY, Jeon Y, Seong SJ, Seo JJ, Choi JY, Cho JH, Park SH, Kim CD, Yoon YR, Yoon SH, Lee JS, Kim YL. ICT-based adherence monitoring in kidney transplant recipients: a randomized controlled trial. BMC Med Inform Decis Mak. 2020 Jun 10;20(1):105. doi: 10.1186/s12911-020-01146-6.

    PubMed 32522263

  • Jung HY, Seong SJ, Choi JY, Cho JH, Park SH, Kim CD, Yoon YR, Kim HK, Huh S, Yoon SH, Lee JS, Kim YL. The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):480. doi: 10.1186/s13063-017-2221-z.

    PubMed 29037222

Questions about this trial

What is this clinical trial studying?

A study testing Feedback using ICT based monitoring system in people with Kidney Transplantation, run by Kyungpook National University Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug adherence (time frame: at 6 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03136588, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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