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

NCT03136588 | Completed DMC

• 1 other identifier: ICT_COM_P01_KT-ver2.4
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

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').

Conditions

Kidney Transplantation

Keywords

Information and Communication Technology; Adherence; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

ICT based monitoring group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Use standard questionnaire to gather information for drug adherence

Interventions

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.

ICT based monitoring group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator
• Korea Evaluation Institute of Industrial Technology: collaborator
• Daegu Metropolitan City, Korea: collaborator
• ICT Clinical Trial Coordination Center: collaborator

Study Sites (2)

Konyang University Hospital

Daejeon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (9)

• 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.

  PMID: 22081892 BACKGROUND

• 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.

  PMID: 19843035 BACKGROUND

• 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.

  PMID: 18294158 BACKGROUND

• 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.

  PMID: 11558866 BACKGROUND

• 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.

  PMID: 26588006 BACKGROUND

• 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.

  PMID: 19770778 BACKGROUND

• 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.

  PMID: 36094829 DERIVED

• 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.

  PMID: 32522263 DERIVED

• 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.

  PMID: 29037222 DERIVED

Study Officials

• Yong-Lim KIM, MD, PhD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 2, 2017
• Study Start: January 1, 2017
• Primary Completion: August 23, 2018
• Study Completion: December 31, 2018
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)