Usability and Safety Study of MuCopilot Mobile App for Monitoring Cystic Fibrosis at Home

What this Trial Is About

Researchers are evaluating the usability and safety of the MuCopilot smartphone application, designed to measure lung function, exercise capacity, and patient-reported outcomes in adults with Cystic Fibrosis CF. The study aims to ensure that patients can use this medical device correctly without significant errors or risks. This evaluation involves 17 CF patients in France and focuses on unsupervised digital tests performed at home between clinical visits. Participants will download the free MuCopilot app and use it to complete three digital tests monitoring cough, breathing difficulty, and walking ability, along with a symptom questionnaire. The study involves one inclusion visit and one in-clinic visit lasting about 1.5 hours, during which patients will perform these digital assessments under supervision to validate usability and safety. During the trial, researchers will observe how easily and safely participants use the app, collecting data on lung function and exercise capacity along with patient responses to symptom questions. The primary outcomes include validation of usability, safety of use, and ease of use, each assessed over approximately two hours. The study runs until February 2025 and does not include healthy volunteers.

A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis