NCT06132048Recruiting
A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- First submitted
- 31 Oct 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- Ad scientiam
- Diseases
- Cystic fibrosis
- NCT number
- NCT06132048
What you commit to
- Study type: Interventional
- Planned participants: 17
- From 1 Jul 2024 to the primary completion date, 15 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of lung transplantation
- Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement)
Other
- Pregnant women and women who are breastfeeding
- Illiterate in French
- Inability to use a smartphone or MuCopilot application
- Person under legal protection (including guardianship or curatorship)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CRCM Mixte - Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.