CompletedNot Applicable

The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis

United States52 participantsStarted 2021-08-30

Plain-language summary

The goal of this pilot study is to determine the reliability of myasthenia gravis (MG) specific outcome measures obtained during virtual encounters with patients with myasthenia gravis. The main question it aims to answer is: Are MG-specific outcome measures obtained during virtual encounters reliable? Participants will complete two virtual study visits in which they will be administered common MG-specific outcome measures and a newly developed outcome measure developed specifically for telemedicine assessments of MG patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has the capacity to understand and sign an informed consent form * 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 * Subject has 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. * Is 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score.

Timeframe: 3 days (+/- 1 day)

Intrarater reliability (test-retest reliability) of the MGC-v score.

Timeframe: 3 days (+/- 1 day)

Trial details

NCT IDNCT05917184

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-20

View on ClinicalTrials.gov More Myasthenia Gravis trials