Descriptive Analysis of Real-world Data Collected With ME&MGopen

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Descriptive Analysis of Real-world Data Collected With the ME&MGopen Mobile Application Developed for Myasthenia Gravis Patients

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Device: ME&MGopen smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Participating in another ME&MG trial Aged 17 years or younger A medical, psychological, or behavioral condition which interferes with compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ME&MGopen<br>Use of ME&MGopen mobile app, at home for 12 months | Device: ME&MGopen smartphone application<br>* Smartphone application includes digital tests and e-questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe real-life upper limb weakness mesurements | Time in seconds measured with the ME&MGopen smartphone application (holding the phone in one arm for as long as possible) | Through study completion, an average of 12 months | 
| To describe real-life lower limb weakness measurements | Number of sit-to-stand actions measured with the ME&MGopen smartphone application (1 minute sit-to-stand test) | Through study completion, an average of 12 months | 
| To describe real-life ptosis measurements | Margin-Reflex Distance 1 (MRD1) measured with the ME&MGopen smartphone application | Through study completion, an average of 12 months | 
| To describe real-life dysarthria measurements | Time in seconds measured with the ME&MGopen smartphone application | Through study completion, an average of 12 months | 
| To describe real-life respiratory capacity measurements | Time in seconds measured with the ME&MGopen smartphone application : saying aaaaahhh for as long as possible | Through study completion, an average of 12 months | 
| To describe activities of daily living | Myasthenia Gravis Activities of Daily Living scores (0-24) higher score meaning a worse outcome | Through study completion, an average of 12 months | 
| To describe depression symptoms | Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome | Through study completion, an average of 12 months | 
| To describe pain symptoms | Pain Likert scale scores(0-10) higher score meaning a worse outcome | Through study completion, an average of 12 months | 
| To describe insomnia symptoms | 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) | Through study completion, an average of 12 months | 
| To describe quality of life related to MG | Myasthenia Gravis Quality of Life 15-item Scale revised scores (0-30) higher score meaning a worse outcome | Through study completion, an average of 12 months | 
| To describe quality of life | 36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome | Through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the reliability of the digital tests performed at home in real-life | The intraclass correlation coefficient mean k raters (ICCk; k=month) will be used to assess the monthly reliability at home of digital tests from the beginning to the end of participation : At-home MET At-home MBT At-home MVT At-home MAT At-home MLT | 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 adherence to the mobile application | Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, carried tests, number of sessions performed etc.) | through study completion, 30 months | 
| To assess the satisfaction and user experience with the smartphone application | Descriptive analysis (counts/percentages) of the answers to the user experience and satisfaction questionnaires related to the use of the ME&MGopen smartphone application | through study completion, 30 months | 
| To assess user behavior | Description of user behavior (counts/percentages) | through study completion, 30 months | 
| To assess safety of use of the smartphone application | Descriptive analysis of adverse events (AEs) related and unrelated to the use of the application. Adverse event data will be reported in a table and expressed as number and percentage, differentiating mild, moderate and severe AEs. | through study completion, 30 months | 
| To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect | p-value | through study completion, 30 months | 
| To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments | Matrix correlation to estimate Pearson's correlation coefficient for each pair of relevant variables. | through study completion, 30 months | 
| To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application | coefficient of correlation between dimensions of the Health Belief Model and device use | 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 | p-value from multiple regression | 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 | p-value from multiple regression | through study completion, 30 months | 
| To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application | p-value from multiple regression | through study completion, 30 months | 
| To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application | p-value from multiple regression | 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 | coefficient of correlation | through study completion, 30 months |