Related Experiment Video
Updated: Oct 14, 2025
04:24
A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
11.9K
Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App):
Deeptee Jain1, Kevin Norman2, Zachary Werner2
1Department of Orthopaedic Surgery, Washington University in St. Louis, St. Louis, MO, United States.
JMIR Human Factors
|November 9, 2021
Summary
The Kaia App, a digital therapeutic for low back pain, demonstrated a very low rate of adverse events (AEs) in real-world use. Most reported AEs were mild and consistent with in-person therapies, though reporting bias is likely.
Area of Science:
- Digital health
- Musculoskeletal disorders
- Evidence-based medicine
Background:
- Low back pain (LBP) is a global health issue, causing significant disability.
- Digital therapeutics offer promising, effective treatments for LBP.
- Systematic data on the safety of digital therapeutics for LBP is limited.
Purpose of the Study:
- To assess the safety profile of the Kaia App, a multidisciplinary digital therapeutic for LBP.
- To comprehensively evaluate adverse events (AEs) reported by users through postmarket surveillance.
Main Methods:
- Analysis of user-reported messages from the Kaia App (2018-2019) for AEs.
- Categorization of AEs by type, seriousness, and relation to the app.
- Evaluation of user demographics and app usage data for AE reporting risk factors.
Main Results:
- 0.09% of 138,337 users reported AEs, with increased pain being the most common nonserious AE.
- Older users (55-65 and ≥75 years) had higher odds of reporting AEs.
- AE reporting was higher in users with fewer active days on the app.
Conclusions:
- The Kaia App exhibits a low overall rate of reported adverse events in real-world usage.
- Reported AEs are generally consistent with those of traditional LBP therapies.
- Potential reporting bias exists, and further research into digital therapeutic safety is warranted.
