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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form - Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion - Able to read French and understand pictograms on a smartphone app Who Should NOT Join This Trial: - 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 - Inability to use a smartphone or MuCopilot application - Person under legal protection (including guardianship or curatorship) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 * Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion * Able to read French and understand pictograms on a smartphone app Exclusion Criteria: * 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 * Inability to use a smartphone or MuCopilot application * Person under legal protection (including guardianship or curatorship)

Treatments Being Tested

DEVICE

MuCopilot mobile application

MuCopilot is a software as medical device with three digital tests, to measure patient's with CF, lung function, global exercise capacity and a questionnaire to address CF symptoms and impacts on some aspects of patient's life

Locations (1)

CRCM Mixte - Hôpital Charles Nicolle
Rouen, France