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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-27

Study Completion Date

2025-01-10

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.

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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

Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ME&MGopen

Use of ME\&MGopen mobile app, at home for 12 months

ME&MGopen smartphone application

Intervention Type DEVICE

Smartphone application includes digital tests and e-questionnaires

Interventions

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ME&MGopen smartphone application

Smartphone application includes digital tests and e-questionnaires

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No