Susan L Baumgartner

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 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: Digital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events. Objective: Teaching users to operate a DPS is vital to ensure the collection of actionable ingestion and adherence data. In this study, we aim to develop and pilot a training program, grounded in the Technology Acceptance Model, to instruct individuals on DPS operation. Methods: A two-part training program, comprising in-person and text message–based components, was used with HIV-negative men who have sex with men with nonalcohol substance use, who had enrolled in a 90-day pilot demonstration study using the DPS to measure adherence to pre-exposure prophylaxis. We assessed the number of responses to text check-ins, the number and types of episodes where technical support was requested, the resolutions of such issues, and engagement with the program over the study period. Participant feedback on the program was evaluated through qualitative user experience interviews. Results: A total of 15 participants were enrolled in and completed the program. Seven technical challenges related to DPS operations were reported across 5 participants. Most commonly, participants requested support connecting the wearable Reader device with their smartphone, charging the Reader, and operating the mobile app. A total of 6 issues were resolved asynchronously or in real time via phone; 1 required in-person evaluation and resolution. Preliminary qualitative findings indicate that both the in-person and remote follow-up components of the training program were perceived as acceptable. Suggested improvements included repeated DPS refresher sessions at in-person follow-up visits and enhanced written materials for the independent resolution of technological issues. Conclusions: A brief two-part DPS training program, drawing from individuals’ experiences and from the Technology Acceptance Model, can provide valuable insights for users. The program also identifies and addresses several areas of actual or potential challenges related to operating a DPS and allows for the resolution of such issues within the first week of DPS use.

BACKGROUND Digital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events. OBJECTIVE Teaching users to operate a DPS is vital to ensure the collection of actionable ingestion and adherence data. In this study, we aim to develop and pilot a training program, grounded in the Technology Acceptance Model, to instruct individuals on DPS operation. METHODS A two-part training program, comprising in-person and text message–based components, was used with HIV-negative men who have sex with men with nonalcohol substance use, who had enrolled in a 90-day pilot demonstration study using the DPS to measure adherence to pre-exposure prophylaxis. We assessed the number of responses to text check-ins, the number and types of episodes where technical support was requested, the resolutions of such issues, and engagement with the program over the study period. Participant feedback on the program was evaluated through qualitative user experience interviews. RESULTS A total of 15 participants were enrolled in and completed the program. Seven technical challenges related to DPS operations were reported across 5 participants. Most commonly, participants requested support connecting the wearable Reader device with their smartphone, charging the Reader, and operating the mobile app. A total of 6 issues were resolved asynchronously or in real time via phone; 1 required in-person evaluation and resolution. Preliminary qualitative findings indicate that both the in-person and remote follow-up components of the training program were perceived as acceptable. Suggested improvements included repeated DPS refresher sessions at in-person follow-up visits and enhanced written materials for the independent resolution of technological issues. CONCLUSIONS A brief two-part DPS training program, drawing from individuals’ experiences and from the Technology Acceptance Model, can provide valuable insights for users. The program also identifies and addresses several areas of actual or potential challenges related to operating a DPS and allows for the resolution of such issues within the first week of DPS use.