Jung 2017.

Trial name or 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
Methods	Multicentre, open‐label, prospective, RCT (1:1 randomisation). The planned follow‐up duration is 6 months.
Participants	Kidney transplant recipients, n = 114
Interventions	Intervention ICT‐based centralized clinical trial monitoring group (n = 57). Participants are given a smart pill box equipped with a personal identification system. The adherence‐related information obtained from the pill box is saved, monitored, and sent out via a home monitoring system. Of the home monitoring system data, those necessary for the clinical trial are extracted and incorporated into the electronic Case Report Form (eCRF) system. All data is consolidated and managed within the comprehensive clinical trial management system (CTMS). In the ICT‐ based, centralized clinical trial monitoring group, feed‐ back 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. To keep a drug administration diary that specifies date, whether a dose is taken or not, dosing time, and dosage Control Ambulatory follow‐up group (n = 57). To keep a drug administration diary that specifies date, whether a dose is taken or not, dosing time, and dosage
Outcomes	The primary outcome in this trial is adherence to medication, including dose‐taking compliance, dose‐frequency compliance, dose‐interval compliance, drug holidays, medication possession ratio Secondary outcomes: Both groups are to make six office visits after randomisation at 4, 8, 12, 16, 20, and 24 weeks. Each visit requires measurement of blood drug level, creatinine level, and estimated glomerular filtration rate (eGFR). Serum BK virus is assessed at 12 weeks and Panel reactive anti‐ body (PRA) at 24 weeks. At each visit, subjects go over the diary with investigators and fill out a questionnaire using the Modified Morisky Adherence 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 24 weeks. Cost‐effectiveness evaluation parameters include installation of the ICT‐based centralized monitoring system, additional hospitalisation due to non‐adherence, ambulatory tests, and trips for hospital visits. Process evaluation: The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE‐AIM) framework will be used in order to evaluate translatability and feasibility of ICT‐ based centralized monitoring system
Starting date	January 2017
Contact information	ylkim@knu.ac.kr Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, South Korea
Notes	Clinical trials registration: NCT03136588, registered on 20 April 2017