A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ad scientiam
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Validation of usability (1)
研究概览
简要总结
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.
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
- •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
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 (clinician's judgement)
- •Illiterate in French
- •Inability to use a smartphone or MuCopilot application
- •Person under legal protection (including guardianship or curatorship)
结局指标
主要结局
Validation of usability (1)
时间窗: 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.
Validation of usability (2)
时间窗: 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.
Validation of no safety critical of use
时间窗: 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.
Validation of ease of use
时间窗: 2 hours
The MuCopilot solution will be considered as easy to use, if the perceived ease of use" mean score reaches 7.8/10
次要结局
未报告次要终点