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Trial Title:
Descriptive Analysis of Real-world Data Collected With ME&MGopen
NCT ID:
NCT05566964
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
ME&MGopen smartphone application
Description:
Smartphone application includes digital tests and e-questionnaires
Arm group label:
ME&MGopen
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
Criteria for eligibility:
Study pop:
Adults living with generalized Myasthenia Gravis in the US and in Canada
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599-7025
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G 2C4
Country:
Canada
Status:
Active, not recruiting
Facility:
Name:
Lindus Health
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Meri A Beckwith, MSc
Phone:
7392756302
Phone ext:
+44
Email:
meri@lindushealth.com
Start date:
February 27, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Ad scientiam
Agency class:
Other
Source:
Ad scientiam
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566964
