Information and Communication Technology (ICT) Based Centralized Clinical Trial Monitoring System for Drug Adherence
NCT ID: NCT03136588
Last Updated: 2020-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2017-01-31
2018-12-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Control group
Use standard questionnaire to gather information for drug adherence
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Ministry of Trade, Industry & Energy, Republic of Korea
OTHER_GOV
Korea Evaluation Institute of Industrial Technology
OTHER
Daegu Metropolitan City, Korea
OTHER_GOV
ICT Clinical Trial Coordination Center
OTHER
Kyungpook National University Hospital
OTHER
Responsible Party
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Yong-Lim Kim
Principal Investigator
Principal Investigators
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Yong-Lim KIM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital
Locations
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Konyang University Hospital
Daejeon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ICT_COM_P01_KT-ver2.4
Identifier Type: -
Identifier Source: org_study_id
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