Transplant Trial Watch

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

McGillicuddy, J. W., et al.

Annals of Pharmacotherapy 2020 [record in progress].

This is a post hoc analysis of an RCT that aimed to examine the whether a mobile health (mHealth) intervention improved medication adherence and blood pressure (BP) control among high-risk kidney transplant recipients, as compared to usual care. This study aimed to investigate if this intervention led to improvements in intra-patient tacrolimus trough variability.

Patients were randomly assigned to either the mHealth-delivered intervention arm or the attention control arm.

82 kidney transplant recipients

The main outcome of this study was the proportion of patients that obtained normal tacrolimus trough variability, compared between the study groups.

12 months

CET Conclusions
This interesting study investigates the effect of an electronic medication reminder and monitoring tool in reducing tacrolimus variability in high-risk renal transplant recipients. The original RCT was designed to investigate the impact of the intervention on adherence; this post-hoc sub-study focusses on tacrolimus intra-patient variability (IPV). High tacrolimus IPV has been shown previously to correlate with poor graft outcomes and is thought to result at least partly from poor adherence. No previous studies have looked at interventions to directly reduce this risk factor. The study demonstrated that the mHealth intervention was able to reduce IPV significantly in this high-risk group. It should be noted that the study is using IPV as a surrogate for clinical sequelae, and so future prospective studies using clinical endpoints are needed. It is also possible that the patients that agree to participate in a clinical trial are those most likely to respond to intervention, and there may be a subset of poorly adherent patients who would not comply with the study intervention or see benefit.

Trial registration
not applicable

Funding source
Non-industry funded