NCT05566964

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
• Phase: —
• Study type: Observational
• Enrollment: 236 (actual)
• Sponsor: Ad scientiam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DEVICE	ME&MGopen smartphone application	Smartphone application includes digital tests and e-questionnaires

Timeline

• Start date: 2023-02-27
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2022-10-05
• Last updated: 2025-03-10

Locations

3 sites across 3 countries: United States, Canada, United Kingdom