Clinical trial NCT06381284: Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
Official title: Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Neuromuscular Manifestations
Neuromuscular Diseases
Keywords: Social Media
Myasthenia Gravis
Lead sponsor: ZS Associates
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
name: University of California, San Francisco
First posted: 2024-04-24
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who have undiagnosed neuromuscular symptoms

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social media recruitment feasibility
timeFrame: Enrollment period (4-6weeks)
Secondary outcomes:
measure: MG Exercise Assessment Tool validity
timeFrame: 1 year from time of enrollment
Other outcomes:
measure: Time to diagnosis
timeFrame: 1 year from time of enrollment
Locations:
city: Evanston
country: United States
facility: ZS Associates
state: Illinois
Study officials:
affiliation: ZS Associates
name: Ananda Vishnu Pandurangadu, MD
role: PRINCIPAL_INVESTIGATOR
References: