Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 215
- Locations
- 1
- Primary Endpoint
- Social media recruitment feasibility
Study Overview
Brief Summary
This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG).
Detailed Description
Participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). Two assessment tools were developed by the study team: the Impact of Daily Living (IDL) Survey and the MG Exercise Assessment. Both tools were designed using supporting literature, accepted guidelines, and a rigorous review via a panel of practicing neurologist key opinion leaders experienced in treating MG patients.
Adult participants who don't have specific diagnosed neurologic conditions will first be screened for eligibility based on the results of the IDL survey which will query participants on the presence or absence of habits/symptoms characteristic of MG. Those who qualify will complete the MG Exercise Assessment in which participants are provided video instructions to perform a series of 10 physical tests to examine if specific muscle groups undergo inducible fatigue. The results of the MG Exercise Assessment are reviewed by a neurologist to determine if participants would benefit further from an in-person neurologist evaluation for MG by a provider. Each participant is provided with a report of the neurologist's evaluation. Participants will be followed for 1 year through bimonthly communications to determine if and when they followed up with a clinician and if they received a confirmed diagnosis of myasthenia gravis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Reside within the 50 states of the United States at the time of enrollment
- •Age 19 or older if reside in Nebraska or Alabama, Age 21 or older if reside in Mississippi, Age 18 years or older if reside in any other state
- •Active email account
- •Fluency in English (spoken / written), as demonstrated by the ability to read and sign the Informed Consent Form
Exclusion Criteria
- •Live in an overseas territory of the United States
- •Inability or unwillingness to provide written informed consent
- •Diagnosed myasthenia gravis
- •Diagnosed multiple sclerosis
- •Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke
Outcomes
Primary Outcomes
Social media recruitment feasibility
Time Frame: Enrollment period (4-6weeks)
Measure the engagement and feasibility metrics of the social media campaign
Secondary Outcomes
- MG Exercise Assessment Tool validity(1 year from time of enrollment)
Investigators
Ananda Vishnu Pandurangadu, MD
Senior Consultant
ZS Associates