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Open Access 01-12-2017 | Study protocol

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

Authors: Hee-Yeon Jung, Sook Jin Seong, Ji-Young Choi, Jang-Hee Cho, Sun-Hee Park, Chan-Duck Kim, Young-Ran Yoon, Hyung-Kee Kim, Seung Huh, Se-Hee Yoon, Jong Soo Lee, Yong-Lim Kim

Published in: Trials | Issue 1/2017

Abstract

Background

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 costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative.

Methods/design

This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated.

Discussion

This on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs.

Trials registration

ClinicalTrials.gov, Identifier: NCT03136588. Registered on 20 April 2017.

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Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012;12(2):388–99.CrossRefPubMed

Degeest S, Borgermans L, Gemoets H, Abraham I, Vlaminck H, Evers G, et al. Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation. 1995;59(3):340–7.CrossRef

Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001;60(4):1565–70.CrossRefPubMed

Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004;77(5):769–76.CrossRefPubMed

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;9(11):2597–606.CrossRefPubMed

Troppmann C, Benedetti E, Gruessner RWG, Payne WD, Sutherland DER, Najarian JS, et al. Retransplantation after renal allograft loss due to noncompliance—Indications, outcome, and ethical concerns. Transplantation. 1995;59(4):467–71.CrossRefPubMed

Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990;150(7):1377–8.CrossRefPubMed

Butler JA, Peveler RC, Roderick P, Horne R, Mason JC. Measuring compliance with drug regimens after renal transplantation: comparison of self-report and clinician rating with electronic monitoring. Transplantation. 2004;77(5):786–9.CrossRefPubMed

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;8(3):616–26.CrossRefPubMed

10.

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;100(1):203–9.CrossRefPubMed

11.

Reese PP, Bloom RD, Trofe-Clark J, Mussell A, Leidy D, Levsky S, et al. Automated reminders and physician notification to promote immunosuppression adherence among kidney transplant recipients: a randomized trial. Am J Kidney Dis. 2017;69(3):400–9.CrossRefPubMed

12.

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24(1):67–74.CrossRefPubMed

13.

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008;10(5):348–54.CrossRef

14.

Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14(1):1–24.CrossRef

15.

Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997;18(3):187–203.CrossRefPubMed

16.

Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.CrossRefPubMedPubMedCentral

17.

Zanetti-Yabur A, Rizzo A, Hayde N, Watkins AC, Rocca JP, Graham JA. Exploring the usage of a mobile phone application in transplanted patients to encourage medication compliance and education. Am J Surg. 2017;124(4):743–7.

18.

McGillicuddy JW, Gregoski MJ, Weiland AK, Rock RA, Brunner-Jackson BM, Patel SK, et al. Mobile health medication adherence and blood pressure control in renal transplant recipients: a proof-of-concept randomized controlled trial. JMIR Res Protoc. 2013;2(2):e32.CrossRefPubMedPubMedCentral

19.

Porter AK, Taylor SR, Yabut AH, Al-Achi A. Impact of a pill box clinic to improve systolic blood pressure in veterans with uncontrolled hypertension taking 3 or more antihypertensive medications. J Manag Care Spec Pharm. 2014;20(9):905–11.PubMed

20.

Petersen ML, Wang Y, van der Laan MJ, Guzman D, Riley E, Bangsberg DR. Pillbox organizers are associated with improved adherence to HIV antiretroviral therapy and viral suppression: a marginal structural model analysis. Clin Infect Dis. 2007;45(7):908–15.CrossRefPubMedPubMedCentral

21.

Shuker N, van Gelder T, Hesselink DA. Intra-patient variability in tacrolimus exposure: causes, consequences for clinical management. Transplant Rev (Orlando). 2015;29(2):78–84.CrossRef

22.

Weimert NA, DeRotte M, Alloway RR, Woodle ES, Vinks AA. Monitoring of inosine monophosphate dehydrogenase activity as a biomarker for mycophenolic acid effect: potential clinical implications. Ther Drug Monit. 2007;29(2):141–9.CrossRefPubMed

Title: 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
Authors: Hee-Yeon Jung
Sook Jin Seong
Ji-Young Choi
Jang-Hee Cho
Sun-Hee Park
Chan-Duck Kim
Young-Ran Yoon
Hyung-Kee Kim
Seung Huh
Se-Hee Yoon
Jong Soo Lee
Yong-Lim Kim
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-017-2221-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trials registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trials registration

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