Background: Non-adherence to transplant immunosuppression is associated with an elevated risk of allograft loss. Novel, wireless-enabled pill bottles have created the opportunity to monitor patient adherence in real time. Customized reminders may help patients with poor memory or organization. Delivery of adherence data to healthcare providers may motivate patients to improve adherence and help providers to identify barriers to adherence. We hypothesized that customized reminders and early notification to providers would improve adherence to immunosuppression.

Methods: Participants were instructed to store their tacrolimus in the wireless pill bottles (Vitality GlowCaps) for 180 days. The trial enrolled 120 incident kidney transplant recipients at a single center (45% of eligible) during the first 2 weeks after transplant. Participants were randomized 1:1:1 to: 1) customized reminders [including alarms, texts, phone calls and/or emails], 2) customized reminders plus provider notification [every 2 weeks, providers received notification if adherence fell <90% during that period], or 3) usual care [no automated reminders]. The pre-specified primary outcome was adherence measured by pill bottles during the final 90 days of the trial, a time period when visits with transplant providers are less frequent.

Results: Mean age was 50 years; 59% male and 38% black. Three participants dropped out of the trial, all within a week. For the primary outcome (Figure 1), median adherence was 72%, 85% and 52% in the customized reminders, reminders plus provider notification and usual care arms (p<0.001 for comparisons of each intervention to control). A comparison of reminders plus provider notification was only superior to reminders alone in a secondary analysis limited to the last 6 weeks of the trial (p<0.05). Self-rated adherence was higher (p<0.05) in a comparison of the combined intervention arms vs. usual care.

Conclusion: Provider notification and customized reminders improved adherence as measured by wireless pill bottles. These strategies show promise and should be tested in larger, multicenter studies.

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