Descriptive Analysis of Real-world Data Collected with the ME&MGopen Mobile Application Developed for Myasthenia Gravis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ad scientiam
- 入组人数
- 236
- 试验地点
- 3
- 主要终点
- To describe real-life lower limb weakness measurements
研究概览
简要总结
The ME&MGopen smartphone application is an investigational software for research purposes only, developed by Ad Scientiam. It features digital tests to assess the respiratory capacity ("My Breathing" Test), dysarthria ("My Voice" Test), ptosis ("My eyelids" test), as well as upper and lower limb muscle function ("My arms" Test and "My legs" Test). The mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression. The objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use.
详细描述
The ME&MGopen smartphone application is an investigational software for research purposes only, developed by Ad Scientiam. It features digital tests to assess the respiratory capacity ("My Breathing" Test), dysarthria ("My Voice" Test), ptosis ("My eyelids" test), as well as upper and lower limb muscle function ("My arms" Test and "My legs" Test). The mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression.
The objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use.
Analyses will also be performed to identify factors that may influence these parameters and provide levers for understanding and improvement. The existence of a possible learning effect on active testing will also be explored as a data point of interest.
The results will allow researchers to extend their knowledge of gMG from real-life data and of the use of digital tools in a gMG patient population
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Diagnosis of gMG with positive serologic test for anti-AChR autoantibody at screening
- •Who has read the information sheet and signed the informed consent form
- •Owns a personal smartphone which version is above 14 for IOS and 8 for Android included
- •Able to use a smartphone
- •Able to perform the ME&MG tests (based on investigator's judgment)
- •Able to read language in which the mobile application is available (English, Spanish, German) and able to understand pictograms
排除标准
- •Participating in another ME&MG trial
- •Aged 17 years or younger
- •A medical, psychological, or behavioral condition which interferes with compliance
结局指标
主要结局
To describe real-life lower limb weakness measurements
时间窗: Through study completion, an average of 12 months
Number of sit-to-stand actions measured with the ME\&MGopen smartphone application (1 minute sit-to-stand test)
To describe real-life respiratory capacity measurements
时间窗: Through study completion, an average of 12 months
Time in seconds measured with the ME\&MGopen smartphone application : saying "aaaaahhh" for as long as possible
To describe pain symptoms
时间窗: Through study completion, an average of 12 months
Pain Likert scale scores(0-10) higher score meaning a worse outcome
To describe real-life ptosis measurements
时间窗: Through study completion, an average of 12 months
Margin-Reflex Distance 1 (MRD1) measured with the ME\&MGopen smartphone application
To describe real-life dysarthria measurements
时间窗: Through study completion, an average of 12 months
Time in seconds measured with the ME\&MGopen smartphone application
To describe depression symptoms
时间窗: Through study completion, an average of 12 months
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
To describe real-life upper limb weakness mesurements
时间窗: Through study completion, an average of 12 months
Time in seconds measured with the ME\&MGopen smartphone application (holding the phone in one arm for as long as possible)
To describe activities of daily living
时间窗: Through study completion, an average of 12 months
Myasthenia Gravis Activities of Daily Living scores (0-24) higher score meaning a worse outcome
To describe quality of life related to MG
时间窗: Through study completion, an average of 12 months
Myasthenia Gravis Quality of Life 15-item Scale revised scores (0-30) higher score meaning a worse outcome
To describe quality of life
时间窗: Through study completion, an average of 12 months
36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome
To describe insomnia symptoms
时间窗: Through study completion, an average of 12 months
Insomnia Severity Index scores (0-28) higher score meaning a worse outcome, 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
次要结局
- To assess safety of use of the smartphone application(through study completion, 30 months)
- To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect(through study completion, 30 months)
- To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application(through study completion, 30 months)
- To assess adherence to the mobile application(through study completion, 30 months)
- To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application(through study completion, 30 months)
- To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the results to the digital tests and questionnaires(through study completion, 30 months)
- To evaluate the reliability of the digital tests performed at home in real-life(Baseline, month 1, month 2, month 3, Month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12)
- To assess the satisfaction and user experience with the smartphone application(through study completion, 30 months)
- To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application(through study completion, 30 months)
- To assess user behavior(through study completion, 30 months)
- To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments(through study completion, 30 months)
- To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the reliability of the digital tests(through study completion, 30 months)
- To explore the existing association between the ME&MG tests scores obtained at home and the results labeled by a trained evaluator(through study completion, 30 months)