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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-02-28

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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MuCopilot - Summative evaluation

Performance of digital tests and questionnaire from MuCopilot, during the visit.

Group Type EXPERIMENTAL

MuCopilot mobile application

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No