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

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ClinicalTrials.gov Identifier: NCT05566964
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ad scientiam

Study Description
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Brief Summary:
The ME&MGopen smartphone application was developed by Ad Scientiam to allow patients to monitor their symptoms in autonomy between hospitals visits, which are less frequent in practice than disease fluctuations. 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.

Condition or disease Intervention/treatment
Myasthenia Gravis Device: Me&MGopen smartphone application

Detailed Description:

The ME&MGopen smartphone application was developed by Ad Scientiam to allow patients to monitor their symptoms in autonomy between hospitals visits, which are less frequent in practice than disease fluctuations. 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 provide a global view of the use of the tool by patients, and will provide areas of improvement in order to compare it to the standard tests used in the clinic, in an optimized version.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Descriptive Analysis of Real-world Data Collected With the ME&MGopen Mobile Application Developed for Myasthenia Gravis Patients
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ME&MGopen
Use of ME&MGopen mobile app, at home for 12 months
 Device: Me&MGopen smartphone application
Smartphone application includes digital tests and e-questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. To describe real-life upper limb weakness mesurements [ Time Frame: Through study completion, an average of 12 months ]
    Time in seconds measured with the ME&MGopen smartphone application (holding the phone in one arm for as long as possible)

  2. To describe real-life lower limb weakness measurements [ Time Frame: Through study completion, an average of 12 months ]
    Number of sit-to-stand actions measured with the ME&MGopen smartphone application (1 minute sit-to-stand test)

  3. To describe real-life ptosis measurements [ Time Frame: Through study completion, an average of 12 months ]
    Margin-Reflex Distance 1 (MRD1) measured with the ME&MGopen smartphone application

  4. To describe real-life dysarthria measurements [ Time Frame: Through study completion, an average of 12 months ]
    Time in seconds measured with the ME&MGopen smartphone application

  5. To describe real-life respiratory capacity measurements [ Time Frame: Through study completion, an average of 12 months ]
    Time in seconds measured with the ME&MGopen smartphone application : saying "aaaaahhh" for as long as possible

  6. To describe activities of daily living [ Time Frame: Through study completion, an average of 12 months ]
    Myasthenia Gravis Activities of Daily Living scores (0-24) higher score meaning a worse outcome

  7. To describe depression symptoms [ Time Frame: Through study completion, an average of 12 months ]
    Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome

  8. To describe pain symptoms [ Time Frame: Through study completion, an average of 12 months ]
    Pain Likert scale scores(0-10) higher score meaning a worse outcome

  9. To describe insomnia symptoms [ Time Frame: Through study completion, an average of 12 months ]
    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)

  10. To describe quality of life related to MG [ Time Frame: Through study completion, an average of 12 months ]
    Myasthenia Gravis Quality of Life 15-item Scale revised scores (0-30) higher score meaning a worse outcome

  11. To describe quality of life [ Time Frame: Through study completion, an average of 12 months ]
    36-Item Short Form Survey version 1 (0-100) higher score meaning a better outcome


Secondary Outcome Measures :
  1. To evaluate the reliability of the digital tests performed at home in real-life [ Time Frame: 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 ]

    The intraclass correlation coefficient mean k raters (ICCk; k=month) will be used to assess the monthly reliability at home of digital tests from the beginning to the end of participation :

    At-home DPT At-home DBT At-home DDT At-home DULWT At-home DSTST


  2. To assess adherence to the mobile application [ Time Frame: through study completion, 30 months ]
    Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, carried tests, number of sessions performed etc.)

  3. To assess the satisfaction and user experience with the smartphone application [ Time Frame: through study completion, 30 months ]
    Descriptive analysis (counts/percentages) of the answers to the user experience and satisfaction questionnaires related to the use of the ME&MG smartphone application

  4. To assess user behavior [ Time Frame: through study completion, 30 months ]
    Description of user behavior (counts/percentages)

  5. To assess safety of use of the smartphone application [ Time Frame: through study completion, 30 months ]
    Descriptive analysis of adverse events (AEs) related and unrelated to the use of the application. Adverse event data will be reported in a table and expressed as number and percentage, differentiating mild, moderate and severe AEs.

  6. To evaluate the effect of different frequencies of assessments of the digitals tests on the onset of learning effect [ Time Frame: through study completion, 30 months ]
    p-value

  7. To analyze correlations between digital tests, e-questionnaires, socio demographic data, treatments [ Time Frame: through study completion, 30 months ]
    Matrix correlation to estimate Pearson's correlation coefficient for each pair of relevant variables.

  8. To evaluate the ability of the Health Belief Model to predict user behavior towards the smartphone application [ Time Frame: through study completion, 30 months ]
    coefficient of correlation between dimensions of the Health Belief Model and device use

  9. To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the results to the digital tests and questionnaires [ Time Frame: through study completion, 30 months ]
    p-value from multiple regression

  10. To identify if socio-demographic data, treatment status, severity, satisfaction and user experience could influence the reliability of the digital tests [ Time Frame: through study completion, 30 months ]
    p-value from multiple regression

  11. To identify if depression , activities of daily living and satisfaction could influence the adherence to the smartphone application [ Time Frame: through study completion, 30 months ]
    p-value from multiple regression

  12. To identify if socio-demographic data or treatment status could influence satisfaction with the smartphone application [ Time Frame: through study completion, 30 months ]
    p-value from multiple regression


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults living with generalized Myasthenia Gravis in the US and Germany
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 13 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:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05566964


Locations
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United Kingdom
Lindus Health
London, Greater London, United Kingdom
Contact: Meri A Beckwith, MSc    7392756302 ext +44    meri@lindushealth.com   
Sponsors and Collaborators
Ad scientiam
More Information
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Responsible Party: Ad scientiam
ClinicalTrials.gov Identifier: NCT05566964    
Other Study ID Numbers: ME&MGopen
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myasthenia Gravis
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
 Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases