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Randomized Controlled Trial
. 2020 Jun 10;20(1):105.
doi: 10.1186/s12911-020-01146-6.

ICT-based adherence monitoring in kidney transplant recipients: a randomized controlled trial

Hee-Yeon Jung  1 , Yena Jeon  2 , Sook Jin Seong  3 , Jung Ju Seo  1 , Ji-Young Choi  1 , Jang-Hee Cho  1 , Sun-Hee Park  1 , Chan-Duck Kim  1 , Young-Ran Yoon  3 , Se-Hee Yoon  4 , Jong Soo Lee  5 , Yong-Lim Kim  6
Affiliations
Randomized Controlled Trial

ICT-based adherence monitoring in kidney transplant recipients: a randomized controlled trial

Hee-Yeon Jung et al. BMC Med Inform Decis Mak. .

Abstract

Background: Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs.

Methods: In this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6 months, and evaluated patient satisfaction with the ICT-based monitoring system.

Results: Among 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p = 0.012).

Conclusions: Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials.

Trial registration: ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.

Keywords: Adherence; Feedback; Information and communication technology; Kidney transplantation.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow of participants inclusion. A total of 114 KTRs were randomized 1:1 into the intervention group (n = 57) or control group (n = 57). After excluding patients who withdrew consent or dropped out, the final analyses included 51 KTRs in the intervention group and 54 in the control group
Fig. 2
Fig. 2
Dose-taking adherence, dose-frequency adherence, dose-interval adherence, and drug holidays at each period. The two patient groups did not significantly differ in adherence in terms of dosing, time, or drug holidays
Fig. 3
Fig. 3
An example of adherence data in the intervention group as presented in the electronic case report form system. a Monthly data for one subject. b Monthly data for all subjects
See this image and copyright information in PMC

References

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