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

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.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Device: ME&MGopen smartphone application

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

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
• United Kingdom
  • Greater london
    • London, Greater london, United Kingdom
      • Lindus Health
• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7025
      • The University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults living with generalized Myasthenia Gravis in the US and in Canada

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ME&MGopen; Use of ME&MGopen mobile app, at home for 12 months	Device: ME&MGopen smartphone application; Smartphone application includes digital tests and e-questionnaires

What is the study measuring?

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 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 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 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 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 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

Collaborators and Investigators

• Sponsor: Ad scientiam

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Myasthenia Gravis
• Other Study ID Numbers: ME&MGopen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No