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Completed

NCT Number: NCT05566964

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

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ME&MGopen smartphone application

Device

Smartphone application includes digital tests and e-questionnaires

Primary outcomes

  1. To describe real-life upper limb weakness mesurements

    Time frame: 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)

  2. To describe real-life lower limb weakness measurements

    Time frame: 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)

  3. To describe real-life ptosis measurements

    Time frame: Through study completion, an average of 12 months

    Margin-Reflex Distance 1 (MRD1) measured with the ME&MGopen smartphone application

  4. To describe real-life dysarthria measurements

    Time frame: Through study completion, an average of 12 months

    Time in seconds measured with the ME&MGopen smartphone application

  5. To describe real-life respiratory capacity measurements

    Time frame: 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

  6. To describe activities of daily living

    Time frame: Through study completion, an average of 12 months

    Myasthenia Gravis Activities of Daily Living scores (0-24) higher score meaning a worse outcome

  7. To describe depression symptoms

    Time frame: Through study completion, an average of 12 months

    Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome

  8. To describe pain symptoms

    Time frame: Through study completion, an average of 12 months

    Pain Likert scale scores(0-10) higher score meaning a worse outcome

  9. To describe insomnia symptoms

    Time frame: 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)

  10. To describe quality of life related to MG

    Time frame: 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

  11. To describe quality of life

    Time frame: Through study completion, an average of 12 months

    36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome

Secondary outcomes

  1. To evaluate the reliability of the digital tests performed at home in real-life

    Time frame: 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

  2. To assess adherence to the mobile application

    Time frame: 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.)

  3. To assess the satisfaction and user experience with the smartphone application

    Time frame: 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

  4. To assess user behavior

    Time frame: through study completion, 30 months

    Description of user behavior (counts/percentages)

  5. To assess safety of use of the smartphone application

    Time frame: 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.

  6. To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect

    Time frame: through study completion, 30 months

    p-value

  7. To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments

    Time frame: through study completion, 30 months

    Matrix correlation to estimate Pearson's correlation coefficient for each pair of relevant variables.

  8. To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application

    Time frame: through study completion, 30 months

    coefficient of correlation between dimensions of the Health Belief Model and device use

  9. To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the results to the digital tests and questionnaires

    Time frame: through study completion, 30 months

    p-value from multiple regression

  10. To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the reliability of the digital tests

    Time frame: through study completion, 30 months

    p-value from multiple regression

  11. To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application

    Time frame: through study completion, 30 months

    p-value from multiple regression

  12. To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application

    Time frame: through study completion, 30 months

    p-value from multiple regression

  13. To explore the existing association between the ME&MG tests scores obtained at home and the results labeled by a trained evaluator

    Time frame: through study completion, 30 months

    coefficient of correlation

Sponsors and collaborators

Lead sponsor

Ad scientiam

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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