Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
To describe real-life dysarthria measurements |
Time in seconds measured with the ME&MGopen smartphone application |
Through study completion, an average of 12 months |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
To describe depression symptoms |
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome |
Through study completion, an average of 12 months |
|
| Primary |
To describe pain symptoms |
Pain Likert scale scores(0-10) higher score meaning a worse outcome |
Through study completion, an average of 12 months |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
To assess user behavior |
Description of user behavior (counts/percentages) |
through study completion, 30 months |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
