Evaluation of a smartphone app for assessing cystic fibrosis at home

Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

This study tests a smartphone app called MuCopilot to see if it can help people with cystic fibrosis check their lung function and exercise ability at home, compared to regular tests done in a clinic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ad scientiam (Academic / other)
• Locations: 7 sites (Lyon and 6 other locations)
• Trial ID: NCT06147778 on ClinicalTrials.gov

What this trial studies

This study evaluates MuCopilot, a smartphone application designed to objectively measure lung function, exercise capacity, and patient-reported outcomes in individuals with cystic fibrosis. Participants will perform unsupervised digital tests at home, and the results will be compared to standard in-clinic assessments. The study aims to establish the correlation between home-based digital tests and traditional methods, while also assessing the app's accuracy, reliability, and user satisfaction. Additionally, exploratory objectives will investigate the relationship between MuCopilot scores and established clinical measures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older living with cystic fibrosis who have access to a smartphone and the internet.

Not a fit: Patients with a history of lung transplantation or those unable to use a smartphone may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could enable more accurate and convenient monitoring of cystic fibrosis, improving patient management and outcomes.

How similar studies have performed: Other studies have shown promise in using digital tools for health monitoring, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Adult (≥ 18 years old) patients living with Cystic Fibrosis (CF)
* 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 Operating System (OS) is equal or above 14 for iOS (iPhone) and 8 for Android, and have access to a good internet connexion
* Able to read language in which the mobile application is available and able to understand pictograms on the application

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 (investigator's judgement)
* Illiteracy in French
* Inability to use a smartphone or MuCopilot application
* Persons under legal protection (i.e guardianship or curatorship)
* Participation in another clinical interventional study within 30 days prior to selection or current participation in another study that, in the opinion of the investigator, could interfere with the proper conduct and results of the study

Where this trial is running

Lyon and 6 other locations

• Centre Hospitalier Lyon Sud (Adultes) — Lyon, France (Not_yet_recruiting)
• APHM - Hôpital Nord de Marseille — Marseille, France (Not_yet_recruiting)
• Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice — Nice, France (Recruiting)
• American Memorial Hospital — Reims, France (Not_yet_recruiting)
• Centre de Perharidy, Fondation Idlys — Roscoff, France (Not_yet_recruiting)
• CRCM Mixte - Hôpital Charles Nicolle — Rouen, France (Recruiting)
• Hôpital Larrey — Toulouse, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Christophe Marguet, MD — CHU Rouen Charles Nicolle
• Study coordinator: Christophe Marguet, Dr

Conditions Cystic Fibrosis