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NCT Number: NCT06132048

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

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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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRCM Mixte - Hôpital Charles Nicolle

Rouen, 76031, France

Location status: Recruiting

Location contact

Christophe MARGUET, Prof

CONTACT

02.32.88.82.17

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Validation of usability (1)

    Time frame: 2 hours

    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. Validation of usability (2)

    Time frame: 2 hours

    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.

  3. Validation of no safety critical of use

    Time frame: 2 hours

    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.

  4. Validation of ease of use

    Time frame: 2 hours

    The MuCopilot solution will be considered as easy to use, if the perceived ease of use" mean score reaches 7.8/10

Sponsors and collaborators

Lead sponsor

Ad scientiam

Other

Registry information

Acronym: MuControl-Sum

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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