Transplant Trial Watch

Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial.

Fleming, J. N., et al.

American Journal of Health System Pharmacy 2021 [record in progress].


Aims
This was a planned secondary analysis of the TRANSAFE Rx study, which was a randomised controlled trial comparing the efficacy of a mobile health (mHealth)-based intervention versus usual care in improving health outcomes and medication safety among renal transplant patients. The aim of this analysis was to determine the impact of the mHealth intervention on tacrolimus intrapatient variability (IPV).

Interventions
Participants in the TRANSAFE Rx study were randomised to either the mhealth intervention group or the usual care group.

Participants
136 adult kidney transplant recipients.

Outcomes
Measurement of tacrolimus IPV for each treatment arm.

Follow-up
12 months

CET Conclusions
Variability in tacrolimus levels (IPV) is associated with inferior outcomes following renal transplantation and has been suggested to be a surrogate for non-adherent behaviour. This study randomised patients to a pharmacist-led mHealth intervention (including medication reminders, blood pressure and glucose monitoring and pharmacist monitoring) or standard care. Patients receiving the mHealth intervention demonstrated significantly lower tacrolimus IPV at the end of the study. Whilst very interesting, this is a secondary analysis and no correlation with clinical outcome (e.g. rejection, graft loss) is possible. Future studies should target high-risk populations (e.g. high IPV at baseline, known non-adherence), determine whether the effect is sustained outside of a trial environment and investigate the impact of improved IPV on graft outcomes.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT03247322

Funding source
Non-industry funded