A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study

Abstract

Background Certolizumab pegol (CZP) is an anti-tumor necrosis factor drug approved for the treatment of multiple moderate to severe chronic inflammatory diseases. In the European Union, CZP is approved for administration by subcutaneous self-injection using a prefilled syringe, prefilled pen, or reusable electromechanical auto-injector (electronic device). CimplyMe is a companion app for use alongside CZP self-injection devices, designed to support CZP-treated patients self-managing their treatment and disease. Objective This study aimed to validate the usability of the companion app by demonstrating that tasks required for use can be performed successfully by intended end users. Methods We recruited 15 patients with moderate to severe rheumatoid arthritis, currently prescribed biologic treatment, and using apps on a smart phone. Patients were assessed on their ability to use the companion app in a setting designed to simulate a location where patients regularly administer biologic treatment. To assess the usability of the key features of the app, 8 critical and 3 noncritical tasks were designed. Patients’ success on each task was recorded through observations or knowledge-based questions. Successes with difficulty and use errors were also recorded. If a patient made a use error at the first attempt, a second attempt was allowed. Second-attempt use errors were recorded as a task failure. Results A total of 207 first attempts at the 14 components of the 8 critical tasks were evaluated (3 patients failed to complete one component); 178 (86.0%) critical tasks were successfully completed at the first attempt. The remaining first attempts comprised 16 (7.7%) successes with difficulty and 13 (6.3%) use errors, which had to be repeated. One critical task was not re-attempted by one patient due to time constraints; however, there were no use errors in the 12 completed second attempts. A total of 107 first attempts at the 3 noncritical tasks were made, all of which (107/107, 100.0%) were completed without use errors. Conclusions In simulated testing, patients were able to successfully use the companion app without formal training. This study suggests the companion app is easy to use and could help patients prescribed CZP better manage their treatment and disease.

Mobile App-based documentation of patient-reported outcomes — 3-months results from a proof-of-concept study on modern rheumatology patient management

“…In addition, Apps facilitate additional real-time, time-stamped, and long-term systematic patient-centered data collection and they might serve modern management strategies in the rigid health care systems in the next years [ 37 – 39 ]. A similar approach has been used with electronic diaries in clinical trials to transmit self-measured clinical parameters, and furthermore, diaries on smartphones have been reported to be convenient for users [ 40 – 42 ].…”

Mobile Responsive App—A Useful Additional Tool for Data Collection in the German Pregnancy Register Rhekiss?

“…In the medical context, apps are typically used for quantified self-reported data, self-management programs (e.g., for maternal health behaviour and maternal and infant health), companion apps, or as apps for other interventions (e.g., nutrition and smoking cessation) (30)(31)(32). Although it has recently been reported that medical app use in patients with rheumatic disease in Germany is quite low, more than 97% of the patients conveyed that they would consent to share their mobile app data for research purposes (33).…”

Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices

“…Expanding beyond this includes integrated sensors and apps enabling drugs to aid in chronic disease management, which can collect a variety of data from general adherence to pharmacokinetic and pharmacodynamic data that could better inform patients and their providers about usage behaviors to optimize drug adherence and treatment [9,42,43]. The next step will be fully connected DDCPs dispensed from the pharmacy, which has been seen with bioingestible sensors in oral medications and connected inhalers [44,45]. Both innovators and strategics have achieved limited product commercialization and have not yet fully explored how user error could impact collected data in chronic disease management [46].…”