Smart Blister System with and without Mobile App Support: A Randomized Controlled Usability Trial

Medication non-adherence remains a major barrier to effective long-term disease management. Smart packaging technologies offer digital solutions to monitor and support adherence. This study evaluated the usability and feasibility of a smart blister pack (Cerepak^®) for monitoring medication adherence, both with and without a mobile adherence app (MEMS^® Mobile), in healthy adult participants.

In this randomized controlled trial, 36 participants were assigned to use the smart blister pack either with the mobile adherence app (intervention) or without the app (control) over eight weeks, simulating twice-daily medication intake. Usability was assessed using the System Usability Scale (SUS) and user experience surveys. Semi-structured interviews explored user satisfaction, barriers, and suggestions for improvement. Adherence was measured electronically and via pill counts.

Usability scores were significantly higher in the intervention group (median SUS: 80.0) compared to the control group (67.5; p = 0.0007). Participants appreciated the packaging's visual layout and the app's reminder and tracking features. Qualitative findings highlighted improved structure, motivation, and ease of use with the app, alongside technical and packaging challenges. Electronic adherence was 91.7% in the app group and 86.2% in the non-app group. Pill count adherence was 96.4% and 88.0%, respectively. No statistically significant differences were observed. Intermittent data capture issues associated with the smart blister pack led to minor performance inconsistencies in 10.4% of packages, which were accounted for in the analysis, ensuring data integrity.

The smart blister pack is usable and feasible for daily medication taking and tracking, particularly when supported by a mobile app. These findings support further research into clinical populations and long-term implementation studies.