Actively Recruiting
A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Led by Ad scientiam · Updated on 2025-01-29
17
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60; 18 years old
- Patients diagnosed with cystic fibrosis
- Enrolled in or benefiting from a Social Security program
- Have read the information sheet and signed the informed consent form
- Own a personal smartphone with iOS version 14 or higher or Android version 8 or higher, with a good internet connection
- Able to read French and understand pictograms on a smartphone app
You will not qualify if you...
- 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 the MuCopilot application
- Person under legal protection (including guardianship or curatorship)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CRCM Mixte - Hôpital Charles Nicolle
Rouen, France, 76031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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