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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: MuCopilot mobile application


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MuCopilot - Summative evaluation<br>Performance of digital tests and questionnaire from MuCopilot, during the visit. | Device: MuCopilot mobile application<br>* 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<br>|

What is the study measuring?
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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 |