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NCT06147778 | RECRUITING | Cystic Fibrosis

Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Sponsor:

To the knowledge

Brief Summary:

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.

Condition or disease

Cystic Fibrosis

Intervention/treatment

MuCopilot mobile application

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Actual Study Start Date : 2024-09-18
Estimated Primary Completion Date : 2025-09-18
Estimated Study Completion Date : 2025-09-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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 (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
Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

Location Details

NCT06147778

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

France,

Lyon South Hospital Center (adults)

Lyon, France, 69495

NOT YET RECRUITING

France,

APHM - North Hospital of Marseille

Marseille, France, 13015

RECRUITING

France,

Center for Rare Pulmonary Diseases Center Pasteur CHU in Nice

Nice, France, 06002

NOT YET RECRUITING

France,

American Memorial Hospital

Reims, France, 51100

NOT YET RECRUITING

France,

Center of Perharidy, Idlys Foundation

Roskoff, France, 29682

RECRUITING

France,

Mixed CRCM - Charles Nicolle Hospital

Rouen, France, 76031

NOT YET RECRUITING

France,

Larrey hospital

Toulouse, France, 31059