8202: Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis (ADAPT-teleMG)

Background

The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis (ADAPT-teleMG), a preliminary study to evaluate MG telehealth visits and to determine if outcome assessment tools administered in a virtual setting are valid and reliable.  

Objectives

The objective of ADAPT-teleMG is to assess modified versions of existing validated MG specific outcome measures adapted for virtual clinic or research visits. The goal is to validate these telehealth-adapted, MG specific outcome measures for clinical trial settings as well as routine standard of care. We expect this pilot study to not only enhance clinical trial readiness during the current COVID-19 pandemic but also meet clinical research needs in the future. The use of telemedicine allows flexibility for patients as it increases access to specialized care as well as clinical trials for MG patients especially in rural areas.

About this Study

For this proposed pilot study, a total of two video telehealth visits will be conducted and recorded. Approximately 50 adult participants with a confirmed diagnosis of MG will be recruited. The study is open to adults 18–99 years old with an anticipated gender distribution of approximately equal men and women.

Targeted Enrollment: 50

Eligibility Criteria

Inclusion Criteria

• Has the capacity to understand and sign an informed consent form
• ≥18 years old at the time of consent
• 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 or positive edrophonium test
• Have been previously evaluated in a face-to-face clinical encounter at one of the participating study sites within the prior 3 years
• Primary language is English, or equivalent level of English language fluency
• Required disease severity range from asymptomatic-mild to moderate-severe as previously judged by the Investigator.

Exclusion Criteria

• Inadequate technology for telehealth visits as assessed by the investigator (e.g., no internet connection, no laptop/tablet with video capability, etc). Cellular phones are not acceptable. Subjects must use a laptop or tablet.
• Unable or unwilling to comply with the study procedures, including video recording, or telehealth visit.
• Any significant medical/psychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance
• Known pregnancy
• MGFA severity class IVb or V
• Concurrent participation in an interventional clinical trial