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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136588
• Other study ID #: ICT_COM_P01_KT-ver2.4
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2020
• Source: Kyungpook National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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').

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 31, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (5)

Lead Sponsor	Collaborator
Kyungpook National University Hospital	Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center, Korea Evaluation Institute of Industrial Technology, Ministry of Trade, Industry & Energy, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View 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. — View Citation

Henriksson J, Tydén G, Höijer J, Wadström 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. — View 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. — View Citation

Schäfer-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. — View Citation

Sellarés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunosuppressive drug levels	Tacrolimus, Mycophenolic acid trough level	At every 4 weeks up to 24 weeks after enrollment
Secondary	Incidence of biopsy-proven acute rejection	Biopsy-proven acute rejection	Up to 24 weeks after enrollment
Secondary	Development of de novo panel reactive antibody	De novo panel reactive antibody	Up to 24 weeks after enrollment
Secondary	Development of polyomavirus (BK virus) infection	Polymerase chain reaction (PCR) of blood BK virus	Up to 24 weeks after enrollment
Secondary	Changes in renal allograft function	Serum creatinine, estimated glomerular filtration rate	From baseline to 24 weeks after enrollment
Secondary	Changes in ICT-based centralized monitoring system satisfaction scores of patients assessed by system satisfaction questionnaire	System satisfaction questionnaire score	From 4 weeks to 24 weeks after enrollment
Secondary	Malfunction rate of ICT-based centralized monitoring system	Malfunction rate	Up to 24 weeks after enrollment