Clinical trial NCT05566964: Descriptive Analysis of Real-world Data Collected with ME&MGopen
Official title: Descriptive Analysis of Real-world Data Collected with the ME&MGopen Mobile Application Developed for Myasthenia Gravis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living with generalized Myasthenia Gravis in the US and in Canada

Brief 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

Eligibility 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

Primary outcomes:
measure: To describe real-life upper limb weakness mesurements
timeFrame: Through study completion, an average of 12 months
measure: To describe real-life lower limb weakness measurements
timeFrame: Through study completion, an average of 12 months
measure: To describe real-life ptosis measurements
timeFrame: Through study completion, an average of 12 months
measure: To describe real-life dysarthria measurements
timeFrame: Through study completion, an average of 12 months
measure: To describe real-life respiratory capacity measurements
timeFrame: Through study completion, an average of 12 months
measure: To describe activities of daily living
timeFrame: Through study completion, an average of 12 months
measure: To describe depression symptoms
timeFrame: Through study completion, an average of 12 months
measure: To describe pain symptoms
timeFrame: Through study completion, an average of 12 months
measure: To describe insomnia symptoms
timeFrame: Through study completion, an average of 12 months
measure: To describe quality of life related to MG
timeFrame: Through study completion, an average of 12 months
measure: To describe quality of life
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: To evaluate the reliability of the digital tests performed at home in real-life
timeFrame: 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
measure: To assess adherence to the mobile application
timeFrame: through study completion, 30 months
measure: To assess the satisfaction and user experience with the smartphone application
timeFrame: through study completion, 30 months
measure: To assess user behavior
timeFrame: through study completion, 30 months
measure: To assess safety of use of the smartphone application
timeFrame: through study completion, 30 months
measure: To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect
timeFrame: through study completion, 30 months
measure: To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments
timeFrame: through study completion, 30 months
measure: To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application
timeFrame: through study completion, 30 months
measure: To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the results to the digital tests and questionnaires
timeFrame: through study completion, 30 months
measure: To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the reliability of the digital tests
timeFrame: through study completion, 30 months
measure: To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application
timeFrame: through study completion, 30 months
measure: To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application
timeFrame: through study completion, 30 months
measure: To explore the existing association between the ME&MG tests scores obtained at home and the results labeled by a trained evaluator
timeFrame: through study completion, 30 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: London
country: United Kingdom
facility: Lindus Health
state: Greater london
Study officials:
References: