Clinical trial NCT03136588: Information and Communication Technology (ICT) Based Centralized Clinical Trial Monitoring System for Drug Adherence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: Information and Communication Technology
Adherence
Kidney transplantation
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
name: Korea Evaluation Institute of Industrial Technology
name: Daegu Metropolitan City, Korea
name: ICT Clinical Trial Coordination Center
First posted: 2017-05-02
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized in a 1:1 ratio to either Information and Communication Technology (ICT) based centralized clinical trial monitoring system or control group
Primary purpose: TREATMENT

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').

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

Eligibility criteria: 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

Primary outcomes:
measure: Drug adherence
timeFrame: at 6 months after enrollment
Secondary outcomes:
measure: Immunosuppressive drug levels
timeFrame: At every 4 weeks up to 24 weeks after enrollment
measure: Incidence of biopsy-proven acute rejection
timeFrame: Up to 24 weeks after enrollment
measure: Development of de novo panel reactive antibody
timeFrame: Up to 24 weeks after enrollment
measure: Development of polyomavirus (BK virus) infection
timeFrame: Up to 24 weeks after enrollment
measure: Changes in renal allograft function
timeFrame: From baseline to 24 weeks after enrollment
measure: Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire
timeFrame: From 4 weeks to 24 weeks after enrollment
measure: Malfunction rate of ICT-based centralized monitoring system
timeFrame: Up to 24 weeks after enrollment
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Yong-Lim KIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.