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
28 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 18 years or older
- Diagnosed with cystic fibrosis
- Enrolled in or benefiting from a Social Security program
- Has read the information sheet and signed the informed consent form
- Owns a personal smartphone with iOS version 14 or higher, or Android version 8 or higher, with good internet connection
- Can read French and understand pictograms on a smartphone app
You will not qualify if you...
- History of lung transplantation
- Pregnant women or breastfeeding women
- Any medical condition that could interfere with the study conduct or results as judged by the clinician
- Illiterate in French
- Unable to use a smartphone or the MuCopilot application
- Person under legal protection, including guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 hours
Participants use the MuCopilot mobile application to perform digital tests measuring lung function, exercise capacity, and complete a questionnaire about cystic fibrosis symptoms and impacts during a visit.
1 visit (in-person)
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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