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Randomized Controlled Trial
. 2020 Dec;54(12):1185-1193.
doi: 10.1177/1060028020931806. Epub 2020 Jun 8.

Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial

John W McGillicuddy  1 , Jessica L Chandler  1 , Luke R Sox  1 , David J Taber  1
Affiliations
Randomized Controlled Trial

Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial

John W McGillicuddy et al. Ann Pharmacother. 2020 Dec.

Abstract

Background: Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss.

Objective: The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability.

Methods: A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm.

Results: At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs (P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm.

Conclusion and relevance: High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.

Keywords: Smartphone Medication Adherence Saves Kidneys; coefficient of variation; end-stage renal disease; estimated glomerular filtration rate; kidney transplantation; mobile health; randomized controlled trial; standard of care; time weighted coefficient of variation.

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Conflict of interest statement

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) diagram for Recruitment, 6-month active trial and 6-month follow-up of the SMASK Trial. Abbreviations: BP, blood pressure; KTR, kidney transplant recipient; MA, medication adherence; RCT, randomized controlled trial; SBP, systolic BP; SMASK, Smartphone Medication Adherence Saves Kidneys.
Figure 2.
Figure 2.
Tacrolimus variability compared between study arms. The top panel is the rolling 12-month average tacrolimus CV. The bottom panel is the proportion of participants achieving a rolling 12-month average tacrolimus CV of <40%. Abbreviations: Tac, tacrolimus. CV, coefficient of variation
See this image and copyright information in PMC

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