Clinical trial NCT06147778: Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Official title: Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2023-11-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic.
timeFrame: During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1
measure: To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic.
timeFrame: During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1
Secondary outcomes:
measure: To confirm that the results of the MuCopilot digital test at-home (M3-1) are correlated with their standard clinical counterparts performed in-clinic (M3).
timeFrame: During the last in-clinic visit : at Month 3 and the last at-home assessment Month 3 - 1 day
measure: To evaluate the correlation between MuCopilot the digital tests performed in-clinic, and the results of their standard counterparts performed in-clinic
timeFrame: During the first in-clinic visit : Day 0 and the last in-clinic visit : Month 3
measure: To assess intra-patient test-retest reliability of the MuCopilot CF-Scan questionnaire
timeFrame: During at-home visits at Day 1 and Day 3
measure: To assess the safety of the mobile application use.
timeFrame: Throughout the study for all visits in-clinic and at-home Day 0, Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day, Month 3
measure: To assess the satisfaction and user experience with MuCopilot.
timeFrame: Throughout the study, at-home at Day 7, Month 1, Month 3 - 1 day
measure: To assess at-home compliance to MuCopilot.
timeFrame: Throughout the study for all visits in-clinic and at-home Day 0, Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day, Month 3
measure: To evaluate the metric performance of the "Mobile Sleep Cough Monitoring Test" (MSCMT) at-home in comparison to ground truth results labelized by specialists. The data will be collected by the mobile application.
timeFrame: Throughout the study for all visits at-home Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day and all voluntary tests
measure: To evaluate the association between the maximum phonation time determined automatically by the MuCopilot MSPT test at-home and the maximum phonation time evaluated by a trained evaluator on the same dataset.
timeFrame: Throughout the study for all visits at-home Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day
measure: To evaluate the association between the results of the MSPT and MEWT tests scores in-clinic and the results of these same tests determined by the investigator.
timeFrame: During in-clinic visits at Day 0 and 3 months
measure: To assess the reproducibility between MuCopilot tests scores obtained in in-clinic and MuCopilot tests scores obtained at-home
timeFrame: During in-clinic visits at Day 0 and Month 3, and during the at-home visits at Day 1 and Month 3-1 day
measure: To assess the test-retest reliability of MuCopilot tests scores obtained at-home
timeFrame: During at-home visits at Day 1, Day 3, Day 5 and Day 7
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud (Adultes)
city: Marseille
country: France
facility: APHM - Hôpital Nord de Marseille
city: Nice
country: France
facility: Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice
city: Reims
country: France
facility: American Memorial Hospital
city: Roscoff
country: France
facility: Centre de Perharidy, Fondation Idlys
city: Rouen
country: France
facility: CRCM Mixte - Hôpital Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Larrey
Study officials:
affiliation: CHU Rouen Charles Nicolle
name: Christophe Marguet, MD
role: PRINCIPAL_INVESTIGATOR
References: