Background Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. Objective The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment. Methods A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System. Results The participants ranged in age from 27 to 74 years (mean 51 years, SD 13.8 years), and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device. Conclusions The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users.

BACKGROUND Medication nonadherence is a costly problem that is common in clinical use and and clinical trials alike with significant adverse consequences. Digital pill systems have proven to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. OBJECTIVE This human factors validation study evaluated a novel digital pill system, the ID-CapTM System from etectRx, for usability among patient users in a simulated real-world use environment. METHODS Seventeen patients of diverse background who regularly take oral prescription medications were recruited. After training and a period of training decay, participants were asked to complete 12 patient use scenarios during which errors or difficulties were logged. Participants also were interviewed about their experience with the ID-Cap System. RESULTS In this human factors validation study, patient users completed 97% of the use scenarios successfully, and 75% of these were completed without any failures or errors. Participants found the ID-Cap System easy to use and were able to accurately and proficiently record ingestion events using the device. CONCLUSIONS Participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. Regardless of age, educational level, or background, patients were able to use it successfully. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. CLINICALTRIAL Not applicable