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

Ad scientiam

Status: Completed

Conditions: Myasthenia Gravis

Treatments: Device: ME&MGopen smartphone application

Study type: Observational

Funder types: Other

Identifiers

NCT05566964

ME&MGopen

Details and patient eligibility

About

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.

Full 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

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

236 participants in 1 patient group

ME&MGopen

Description:

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

Treatment:

Device: ME&MGopen smartphone application