Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381284
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-18
Brief Title:
Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment
Sponsor:
ZS Associates
Organization:
ZS Associates
Study Overview
Official Title:
Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a fully remote site-less prospective observational study enrolling adults in the United States excluding US 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 httpsbitlyunearthrootcause 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 dont 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 habitssymptoms 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 neurologists 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
Adult participants who dont 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 habitssymptoms 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 neurologists 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None