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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The study aims to evaluate MuCopilot, a smartphone application to measure objective data on lung function (cough and dyspnea tests), global exercise capacity (walking test) and patient-reported outcomes (PROs) 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 demonstrate the correlation of the MuCopilot digital tests at home (D1) with the results of their standard counterparts (D0) carried out in-clinic.
A secondary objective is to determine the accuracy, reliability and reproducibility of tests results, as well as to study the test-retest of the PRO. The study also aims to assess the safety, usability, and satisfaction of the solution.
Exploratory objectives include evaluating the relationship between MuCopilot's scores and other standards such as FVC, FEV1/FVC ratio as well as to explore the correlation with the cough monitoring with patient's perception.
Patients will be able to download MuCopilot app. They will participate in 1 inclusion visit and 7 follow-up visits, scheduled at Day 1, Day 3, Day 5, Day 7, 1 month, 2 months, 3 months - 1 day.
The study will include 70 CF patients and will be conducted in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MuCopilot comparison to clinical standards | Experimental | Performance of digital tests and questionnaire at Day 0, D1, D3, D5, D7, M1, M2, M3-1 and M3, against clinical standards performed at Day 0 and 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic. | A correlation coefficient will be used to assess the relationship between MuCopilot tests (MSPT) on Day 1 (at home) and the corresponding standard test on Day 0 (in the clinic). The objective will be achieved if the correlation coefficient reaches a minimum of 0.70. A head-to-head comparison will be performed on the following tests: MuCopilot "Mobile Sustained Phonation Test" (MSPT) scores (e.g. maximum phonation time calculated during a sustained phonation assessment) and the FEV1 (air volume exhaled during one second) measured by spirometry at the CF centres | During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1 |
| To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic. | A correlation coefficient will be used to assess the relationship between MuCopilot tests (MEWT) on Day 1 (at home) and the corresponding standard test on Day 0 (in the clinic). The objective will be achieved if the correlation coefficient reaches a minimum of 0.70. A head-to-head comparison will be performed on the following tests: MuCopilot "Mobile Endurance Walking Test" (MEWT), i.e. the walking distance (in metres) walked over six minutes on a hard, flat surface at home and the walking distance (in metres) measured during the 6 minute walk test (6MWT) in-clinic | During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To confirm that the results of the MuCopilot digital test at-home (M3-1) are correlated with their standard clinical counterparts performed in-clinic (M3). | According to the same validation principle as for the primaries outcomes, a correlation coefficient will be used to assess the relationship between MuCopilot MSPT and MWT tests at M3 - 1 (at-home) versus standard tests at M3 (in clinic):
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Marguet, MD | CHU Rouen Charles Nicolle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud (Adultes) | Lyon | 69495 | France | |||
| APHM - Hôpital Nord de Marseille |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| During the last in-clinic visit : at Month 3 and the last at-home assessment Month 3 - 1 day |
| To evaluate the correlation between MuCopilot the digital tests performed in-clinic, and the results of their standard counterparts performed in-clinic | A correlation coefficient will be used to assess the individual correlation between the MuCopilot tests and standard tests performed in-clinic: At D0:
| During the first in-clinic visit : Day 0 and the last in-clinic visit : Month 3 |
| To assess intra-patient test-retest reliability of the MuCopilot CF-Scan questionnaire | Intraclass correlation coefficient (ICC) will be used to assess reliability over time between D1 and D3 (on stable patients without signs or symptoms of CF exacerbation). Descriptive analysis of at-home MuCopilot CF-Scan questionnaire between D1 and D3 (Bland-Altman, box plots, etc.). | During at-home visits at Day 1 and Day 3 |
| To assess the safety of the mobile application use. | Adverse events (AEs) and serious adverse events (SAE) related to the use of the application. | Throughout the study for all visits in-clinic and at-home Day 0, Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day, Month 3 |
| To assess the satisfaction and user experience with MuCopilot. | Descriptive analysis of the answers collected in the patient's satisfaction and user experience questionnaires related to the use of MuCopilot. | Throughout the study, at-home at Day 7, Month 1, Month 3 - 1 day |
| To assess at-home compliance to MuCopilot. | Descriptive analysis of the number of questionnaires completed or tests performed by patients divided by the number of questionnaires or tests expected by the protocol. | Throughout the study for all visits in-clinic and at-home Day 0, Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day, Month 3 |
| To evaluate the metric performance of the "Mobile Sleep Cough Monitoring Test" (MSCMT) at-home in comparison to ground truth results labelized by specialists. The data will be collected by the mobile application. | Performance metrics will be used to assess the ability of the digital MSCMT (Mobile Sleep Cough Monitoring Test) trained algorithm to register and automatically detect the cough sounds during sleep to derive :
| Throughout the study for all visits at-home Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day and all voluntary tests |
| To evaluate the association between the maximum phonation time determined automatically by the MuCopilot MSPT test at-home and the maximum phonation time evaluated by a trained evaluator on the same dataset. | A correlation coefficient will be used to assess the association between the maximum phonation time automatically determined by the MuCopilot MSPT test at-home and the maximum phonation time evaluated by a trained evaluator on the same data (at D1, D3, D5, D7, M1, M2, M3-1). | Throughout the study for all visits at-home Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day |
| To evaluate the association between the results of the MSPT and MEWT tests scores in-clinic and the results of these same tests determined by the investigator. | A correlation coefficient will be used to assess the association between the results of the MSPT and MEWT tests scores in-clinic, and the results of these same tests measured simultaneously by the investigator with a stopwatch (time) and an odometer (metres) at D0 and M3. | During in-clinic visits at Day 0 and 3 months |
| To assess the reproducibility between MuCopilot tests scores obtained in in-clinic and MuCopilot tests scores obtained at-home | The intraclass correlation coefficient (ICC) will be used to assess the reproducibility of MuCopilot tests MSPT and MEWT performed at :
| During in-clinic visits at Day 0 and Month 3, and during the at-home visits at Day 1 and Month 3-1 day |
| To assess the test-retest reliability of MuCopilot tests scores obtained at-home | The intraclass correlation coefficient (ICC) will be used to assess the reliability of MuCopilot tests performed at home at D1, D3, D5 and D7, for MSPT and MEWT digital tests. The minimum ICC to reach is 0.8. | During at-home visits at Day 1, Day 3, Day 5 and Day 7 |
| Marseille |
| 13015 |
| France |
| Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice | Nice | 06002 | France |
| American Memorial Hospital | Reims | 51100 | France |
| Centre de Perharidy, Fondation Idlys | Roscoff | 29682 | France |
| CRCM Mixte - Hôpital Charles Nicolle | Rouen | 76031 | France |
| Hôpital Larrey | Toulouse | 31059 | France |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |