Myasthenia Gravis (MG)
Conditions
Keywords
telemedicine, myasthenia gravis, remote monitoring, feasibility study
Brief summary
Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating weakness, which can worsen suddenly without a clear predictor. The hypothesis is that continuous monitoring of key aspects of patient physiology and activity coupled to rigorous telemedicine-performed examination has the potential to detect MG worsening which requires change in treatment with the benefit of avoiding need for hospitalization or emergent therapy. This study is to evaluate the reliability of the technology and patient compliance to the monitoring program
Interventions
None listed
Sponsors
George Washington University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject 1. Has the capacity to understand and sign an informed consent form 2. ≥18 years old 3. Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single fiber electromyography (EMG) or positive edrophonium test 4. Subject has been previously evaluated in a face-to-face clinical encounter at participating study site or referral site within the prior 3 years 5. Primary language is English, or equivalent level of English language fluency 6. Required disease severity range previously judged by the Investigator. MGFA class 1-4a within 3 years of diagnosis without other chronic medical conditions, which compromise participation. 7. Having MG-ADL score above 2 upon entrance to study 8. Patients considered by study PI not to require hospitalization at time of entrance 9. The patient has internet capability and a smart phone compatible with the apps required by the study.
Exclusion criteria
Disease Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Study Completion | 12 months | Proportion of subjects complete the 12-month study |
| Datasets retrieved from study assessments | 12 months | Proportion of assessments provide data sets that can be analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 12 months | Proportion of subjects indicate satisfaction with outcome measure assessment |
| MG-ADL and MG-CE | 12 months | Correlation of MG-CE individual assessments to MG-ADL assessments |
| Fitbit correlation | 12 months | Correlation of Fitbit metrics to MG-ADL and MG-CE |
| Hospital Anxiety and Depression Scale | 12 months | Utilizing HADS questionnaire |
Countries
United States
Outcome results
None listed