A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis (MuControl-Sum)

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: MuCopilot mobile application

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Recruiting
    • CRCM Mixte - Hôpital Charles Nicolle
    • Contact: Christophe MARGUET, Prof; Phone Number: 02.32.88.82.17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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 (clinician's judgement)
• Illiterate in French
• Inability to use a smartphone or MuCopilot application
• Person under legal protection (including guardianship or curatorship)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MuCopilot - Summative evaluation; Performance of digital tests and questionnaire from MuCopilot, during the visit.	Device: MuCopilot mobile application; MuCopilot is a software as medical device with three digital tests, to measure patient's with CF, lung function, global exercise capacity and a questionnaire to address CF symptoms and impacts on some aspects of patient's life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of usability (1)	Use error : Any deviation from the instructions for use that does not result in a response from the medical device other than what the manufacturer intended. Validated if there is no unacceptable use error.	2 hours
Validation of usability (2)	Task completion rate: percentage of use scenarios completed without observation of an unacceptable error. The unacceptable nature of an error is determined according to the risk analysis process covered by ISO 14971:2019. Validated if the success rate on each task must reach 78% at minimum.	2 hours
Validation of no safety critical of use	Safety critical error: a user error that causes a safety incident, where safety is defined as the appearance of a hazardous situation and the related harms linked to an unacceptable risk, as stated in the application version of Risk Analysis. Validated if there is no safety critical error has been identified during the evaluation.	2 hours
Validation of ease of use	The MuCopilot solution will be considered as easy to use, if the perceived ease of use" mean score reaches 7.8/10	2 hours

Collaborators and Investigators

• Sponsor: Ad scientiam

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): July 15, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: ADS-MuControl-Summative-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No