Informations générales (source: ClinicalTrials.gov)
Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis (MuControl)
Interventional
N/A
Ad scientiam (Voir sur ClinicalTrials)
septembre 2024
septembre 2025
05 avril 2025
The study aims to evaluate MuCopilot, a smartphone application to measure objective data
on lung function (cough and dyspnea tests), global exercise capacity (walking test) and
patient-reported outcomes (PROs) 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 demonstrate the correlation of the MuCopilot digital tests at
home (D1) with the results of their standard counterparts (D0) carried out in-clinic.
A secondary objective is to determine the accuracy, reliability and reproducibility of
tests results, as well as to study the test-retest of the PRO. The study also aims to
assess the safety, usability, and satisfaction of the solution.
Exploratory objectives include evaluating the relationship between MuCopilot's scores and
other standards such as FVC, FEV1/FVC ratio as well as to explore the correlation with
the cough monitoring with patient's perception.
Patients will be able to download MuCopilot app. They will participate in 1 inclusion
visit and 7 follow-up visits, scheduled at Day 1, Day 3, Day 5, Day 7, 1 month, 2 months,
3 months - 1 day.
The study will include 70 CF patients and will be conducted in France.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| American Memorial Hospital - 51100 - Reims - France | Bruno RAVONINJATOVO, Dr | Contact (sur clinicalTrials) | |||
| APHM - Hôpital Nord de Marseille - 13015 - Marseille - France | Nadine Dufeu, Dr | Contact (sur clinicalTrials) | |||
| Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice - 06002 - Nice - France | Sylvie Leroy, Pr | Contact (sur clinicalTrials) | |||
| Centre de Perharidy, Fondation Idlys - 29682 - Roscoff - France | Sophie Ramel, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud (Adultes) - 69495 - Lyon - France | Isabelle Durieu, Pr | Contact (sur clinicalTrials) | |||
| CRCM Mixte - Hôpital Charles Nicolle - 76031 - Rouen - France | Christophe Marguet, Prof | Contact (sur clinicalTrials) | |||
| Hôpital Larrey - 31059 - Toulouse - France | Marlène Murris, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult (≥ 18 years old) patients living with Cystic Fibrosis (CF)
- 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 Operating System (OS) is equal or above 14 for
iOS (iPhone) and 8 for Android, and have access to a good internet connexion
- Able to read language in which the mobile application is available and able to
understand pictograms on the application
- Adult (≥ 18 years old) patients living with Cystic Fibrosis (CF)
- 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 Operating System (OS) is equal or above 14 for
iOS (iPhone) and 8 for Android, and have access to a good internet connexion
- Able to read language in which the mobile application is available and able to
understand pictograms on the application
- 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 (investigator's judgement)
- Illiteracy in French
- Inability to use a smartphone or MuCopilot application
- Persons under legal protection (i.e guardianship or curatorship)
- Participation in another clinical interventional study within 30 days prior to
selection or current participation in another study that, in the opinion of the
investigator, could interfere with the proper conduct and results of the study