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- 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; Jung, Hee-Yeon; Seong, Sook Jin; Choi, Ji-Young; Cho, Jang-Hee; Park, Sun-Hee; Kim, Chan-Duck; Yoon, Young-Ran; Kim, Hyung-Kee
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trials Registration: </bold>ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017.
- Subjects
SOUTH Korea; PATIENT monitoring; PATIENT compliance; IMMUNOSUPPRESSIVE agents; IMMUNOSUPPRESSION; KIDNEY transplant complications; INFORMATION &; communication technologies; RANDOMIZED controlled trials; DRUG packaging; BIOTELEMETRY; COMPARATIVE studies; COST effectiveness; DRUG delivery systems; DRUGS; DRUG administration; EXPERIMENTAL design; GRAFT rejection; GRAFT versus host reaction; HOME care services; KIDNEY transplantation; LONGITUDINAL method; RESEARCH methodology; MEDICAL care costs; MEDICAL cooperation; RESEARCH protocols; PATIENT satisfaction; RESEARCH; TIME; EVALUATION research; TREATMENT effectiveness; ECONOMICS
- Publication
Trials, 2017, Vol 18, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-017-2221-z