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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAd scientiam

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

Treatment groups

17 Participants
are divided into 1 treatment group

Sponsors and collaborators