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

NCT05566964 | Completed

• 1 other identifier: ME&MGopen
• Study Type: observational
• Target: 236
• Locations: 3 countries
• Sites: 3

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.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (11)

• To describe real-life upper limb weakness mesurements

  Time in seconds measured with the ME\&MGopen smartphone application (holding the phone in one arm for as long as possible)

  Through study completion, an average of 12 months

• To describe real-life lower limb weakness measurements

  Number of sit-to-stand actions measured with the ME\&MGopen smartphone application (1 minute sit-to-stand test)

  Through study completion, an average of 12 months

• To describe real-life ptosis measurements

  Margin-Reflex Distance 1 (MRD1) measured with the ME\&MGopen smartphone application

  Through study completion, an average of 12 months

• To describe real-life dysarthria measurements

  Time in seconds measured with the ME\&MGopen smartphone application

  Through study completion, an average of 12 months

• To describe real-life respiratory capacity measurements

  Time in seconds measured with the ME\&MGopen smartphone application : saying "aaaaahhh" for as long as possible

  Through study completion, an average of 12 months

• To describe activities of daily living

  Myasthenia Gravis Activities of Daily Living scores (0-24) higher score meaning a worse outcome

  Through study completion, an average of 12 months

• To describe depression symptoms

  Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome

  Through study completion, an average of 12 months

• To describe pain symptoms

  Pain Likert scale scores(0-10) higher score meaning a worse outcome

  Through study completion, an average of 12 months

• To describe insomnia symptoms

  Insomnia Severity Index scores (0-28) higher score meaning a worse outcome, 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

  Through study completion, an average of 12 months

• To describe quality of life related to MG

  Myasthenia Gravis Quality of Life 15-item Scale revised scores (0-30) higher score meaning a worse outcome

  Through study completion, an average of 12 months

• To describe quality of life

  36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome

  Through study completion, an average of 12 months

Secondary Outcomes (13)

• To evaluate the reliability of the digital tests performed at home in real-life

  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

• To assess adherence to the mobile application

  through study completion, 30 months

• To assess the satisfaction and user experience with the smartphone application

  through study completion, 30 months

• To assess user behavior

  through study completion, 30 months

• To assess safety of use of the smartphone application

  through study completion, 30 months

Study Arms (1)

ME&MGopen

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

Device: ME&MGopen smartphone application

Interventions

ME&MGopen smartphone application DEVICE

Smartphone application includes digital tests and e-questionnaires

ME&MGopen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living with generalized Myasthenia Gravis in the US and in Canada

You may qualify if:

• 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

You may not qualify if:

• Participating in another ME\&MG trial
• Aged 17 years or younger
• A medical, psychological, or behavioral condition which interferes with compliance

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (3)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7025, United States

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Lindus Health

London, Greater london, United Kingdom

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 5, 2022
• Study Start: February 27, 2023
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1); CA (1)