Supporting Medication Adherence in Renal Transplantation (SMART): A Pilot Study.

Objective: Nonadherence with immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTX). The aim of this study was to test the effectiveness of a 3 months educational-behavioral intervention aimed at remediating non-adherence in non-adherent RTX as assessed by electronic event monitoring. Methods: This randomized controlled trial (RCT) included 18 non-adherent renal transplant recipients (21.4% f. - age 45.6 ± 1.2 y) identified during a 3 months run-in period measuring NAH using Electronic Event Monitoring (EEM) and using an algorithm to classify patient as NA. NAH patients were randomly assigned to either intervention (IG, N = 6) or enhanced usual care group (EUC, N = 12). NAH was assessed by EEM in both the IG and EUC groups. After the 3 months intervention period, a 6 months follow-up was done. EUC implied usual care and notification of treating physician about NAH as well as severe depression or suicidal ideation if applicable. The 3 months intervention included one home visit and 3 follow-up telephone calls on a monthly basis by a nurse who used behavioral, educational and social support interventions for remediation of NAH. EEM out-prints allowed detailed feedback to patients concerning their individual medication taking dynamics in the IG. Results: EEM parameters improved from baseline until after 3 months intervention in the IG (N = 5) compared to EUC (N = 9) (see figure 1 and 2). The figures only show taking and timing adherence, and indicate the level of NA for being at risk. A generalized estimating equation type logistic regression using a binary sequence of daily EEM events (dose taken or not) showed that at the end of the 3 months intervention period the IG showed 36% lower non-adherence compared with the enhanced usual care group (β = -0.4512, p = 0.0836, two-tailed). At 9 months (after 6 months follow-up) no significant difference between the groups (β = 0.0253, p = 0.95, two-tailed) was found indicating a wean out effect when the intervention was stopped. Conclusions: The findings of this RCT suggest that it was feasible to remediate non-adherence with the immunosuppressive regimen, providing a possible pathway to improve clinical outcome in RTX. [ABSTRACT FROM AUTHOR]