About this trial
The study aims to assess the usability and safety of use of MuCopilot, a smartphone application that measures objective data on lung function, global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations.
The primary objective is to validate the usability and safety of use, in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk.
The study will include 17 CF patients and will be conducted in France. They will participate in 1 inclusion visit and 1 visit in-clinic (1h30).
Patients will be able to download the free MuCopilot mobile application. During the visit, patients will complete 3 digital tests in order to monitor CF functions (cough, dyspnea \& walking) and 1 symptom questionnaire.
Eligibility criteria
Qualifiers
Aged ⩾ 18 years old
Patients diagnosed with cystic fibrosis
Enrolled in or benefiting of a Social Security program
Having read the information sheet and signed the informed consent form
Disqualifiers
History of lung transplantation
Pregnant women and women who are breastfeeding
Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement)
Illiterate in French
Trial design
Treatments tested in this trial
- MuCopilot mobile application