Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens

: 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 χ2=3.97, df=1, p=0.04; EUCG χ2=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, χ2=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.