Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis (MuControl)

Ad scientiam

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: MuCopilot mobile application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06147778

ADS-MuControl-2023

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

MuCopilot comparison to clinical standards

Experimental group

Description:

Performance of digital tests and questionnaire at Day 0, D1, D3, D5, D7, M1, M2, M3-1 and M3, against clinical standards performed at Day 0 and 3 months.

Treatment:

Device: MuCopilot mobile application