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

Sponsor
Ad scientiam
Study ID
NCT06132048
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MuCopilot mobile application — DEVICE
    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

Study Details

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.

Key Dates

First listed
Nov 15, 2023
Start date
Jul 1, 2024
Status verified
Jan 2025
Primary completion
Jul 15, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: MuCopilot - Summative evaluation
    Performance of digital tests and questionnaire from MuCopilot, during the visit.

Primary Outcome Measure

Validation of usability (1) [ Time Frame: 2 hours ]

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