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. 2021 Nov 8;8(4):e30786.
doi: 10.2196/30786.

A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study

Susan L Baumgartner #  1 , D Eric Buffkin Jr #  1 , Elise Rukavina #  2 , Jason Jones #  2 , Elizabeth Weiler #  2 , Tony C Carnes #  1
Affiliations

A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study

Susan L Baumgartner et al. JMIR Hum Factors. .

Abstract

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.

Keywords: digital medication; digital pills; human factors; ingestible event marker; ingestible sensor; medication adherence; medication nonadherence; mobile phone; remote patient monitoring; usability; validation study.

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Conflict of interest statement

Conflicts of Interest: SB, CC, and EB are employees of etectRx, Inc. ER, JJ, and EW are employees of Tensentric, Inc. KJ is a consultant for etectRx, Inc.

Figures

Figure 1
Figure 1
ID-Capsule: a digital pill consisting of a pharmaceutical-grade capsule shell with an embedded ingestible sensor. The ID-Capsule has been designed to encapsulate medications that are tracked using the system. The sensor communicates a digital signal shortly after ingestion and capsule dissolution. The sensor is naturally and safely eliminated through the patient’s gastrointestinal tract.
Figure 2
Figure 2
ID-Cap Reader: a wearable device that detects messages transmitted from the ingested sensor and forwards them to the ID-Cap Patient App and Clinician Dashboard.
Figure 3
Figure 3
The ID-Cap Patient App allows patients to view ingestion events in real time as well as their medication use history. The app can also send patient reminders and alerts.
Figure 4
Figure 4
The Clinician Dashboard enables logging, tracking, and trending of patients’ ingestion events by clinicians. It provides both real-time notifications and a history of ingestion events.
Figure 5
Figure 5
Overview of how the ID-Cap System works.
See this image and copyright information in PMC

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