A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— MuControl-Sum  

Official title:

A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132048
• Other study ID #: ADS-MuControl-Summative-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Ad scientiam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	CRCM Mixte - Hôpital Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Ad scientiam

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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