Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ad scientiam
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1
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
次要结局
- 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).(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(During the first in-clinic visit : Day 0 and the last in-clinic visit : Month 3)
- To assess the safety of the mobile application use.(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 intra-patient test-retest reliability of the MuCopilot CF-Scan questionnaire(During at-home visits at Day 1 and Day 3)
- To assess the satisfaction and user experience with MuCopilot.(Throughout the study, at-home at Day 7, Month 1, Month 3 - 1 day)
- To assess at-home compliance to MuCopilot.(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.(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.(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.(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(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(During at-home visits at Day 1, Day 3, Day 5 and Day 7)