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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05566964

Enrollment

236

Registered

2022-10-05

Start date

2023-02-27

Completion date

2025-01-10

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis

Brief summary

Detailed description

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

Interventions

DEVICEME&MGopen smartphone application

Smartphone application includes digital tests and e-questionnaires

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To describe real-life upper limb weakness mesurements	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 real-life lower limb weakness measurements	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 ptosis measurements	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	Through study completion, an average of 12 months	Time in seconds measured with the ME&MGopen smartphone application
To describe real-life respiratory capacity measurements	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 activities of daily living	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 depression symptoms	Through study completion, an average of 12 months	Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
To describe pain symptoms	Through study completion, an average of 12 months	Pain Likert scale scores(0-10) higher score meaning a worse outcome
To describe insomnia symptoms	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)
To describe quality of life related to MG	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	Through study completion, an average of 12 months	36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome

Secondary

Measure	Time frame	Description
To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application	through study completion, 30 months	p-value from multiple regression
To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect	through study completion, 30 months	p-value
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	coefficient of correlation
To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments	through study completion, 30 months	Matrix correlation to estimate Pearson's correlation coefficient for each pair of relevant variables.
To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application	through study completion, 30 months	coefficient of correlation between dimensions of the Health Belief Model and device use
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	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
To assess adherence to the mobile application	through study completion, 30 months	Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, carried tests, number of sessions performed etc.)
To assess the satisfaction and user experience with the smartphone application	through study completion, 30 months	Descriptive analysis (counts/percentages) of the answers to the user experience and satisfaction questionnaires related to the use of the ME&MGopen smartphone application
To assess user behavior	through study completion, 30 months	Description of user behavior (counts/percentages)
To assess safety of use of the smartphone application	through study completion, 30 months	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.
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	p-value from multiple regression
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	p-value from multiple regression
To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application	through study completion, 30 months	p-value from multiple regression

Countries

Canada, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026