Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment

Neuromuscular Diseases Clinical Trial

Official title:

Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381284
• Other study ID #: MG-001
• Status: Recruiting
• Start date: March 28, 2024
• Est. completion date: May 27, 2025

Study information

• Verified date: April 2024
• Source: ZS Associates
• Contact: Ananda V Pandurangadu, MD
• Phone: 1-847-448-1001
• Email: support[@]unearthrootcause.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 27, 2025
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Neuromuscular Diseases
• Neuromuscular Manifestations

Intervention

Behavioral:
• Social media recruitment
Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment
• Self-Assessment
Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups
• Follow-up
Patients triaged based on their assessed risk of MG are asked to complete recommended follow-up with a clinician to determine presence of myasthenia gravis

Locations

Country	Name	City	State
United States	ZS Associates	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
ZS Associates	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to diagnosis	Evaluate the time to diagnosis for any participant who has a confirmed diagnosis of MG after the completion of the study compared to that reported in literature	1 year from time of enrollment
Primary	Social media recruitment feasibility	Measure the engagement and feasibility metrics of the social media campaign	Enrollment period (4-6weeks)
Secondary	MG Exercise Assessment Tool validity	Estimate preliminary measures of validity for the MG Exercise Assessment Tool	1 year from time of enrollment

External Links

•   Study landing page