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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]

Background: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time., Methods: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up)., Results: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months)., Conclusion: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.