Unearth Root Cause Study
Study Title
Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired with a Self-moderated Assessment
Clinicaltrials.gov Identifier:
Recruitment Status
Open to recruitment
Sponsor
ZS Associates, a global consulting firm, is the study sponsor. This study is co-funded by ZS Associates and UCB, a global biopharmaceutical company.
ZS is conducting the study in coordination with the University of California San Francisco (UCSF) and UCB. UCSF does not support or endorse ZS Associates or UCB or their products.
Study Investigators
Background
This is an observational data collection study to evaluate the ability 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). Participants with undiagnosed neuromuscular symptoms will be recruited via social media using targeted advertisements. 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 neurologist key opinion leaders.
Objectives
This proposed pilot study has 3 objectives:
- To measure the engagement and feasibility metrics of the social media campaign,
- To estimate preliminary measures of validity for the MG Exercise Assessment Tool, and
- To 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.
About This Study
Adult participants who don't have specific diagnosed neurologic conditions will first be screened for inclusion 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 our co-principal investigator (a UCSF affiliated, board-certified neurologist) to determine if participants would benefit further from an in-person neurologist evaluation for MG. Each participant is provided with a report of the neurologist's evaluation. Participants are 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.
Participating Sites
This study is site-less and fully remote
Targeted Enrollment
100 participants completing the MG Exercise Assessment (~1000 total enrollees)
Enrollment Criteria
Inclusion Criteria
-
Age 19 years 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
-
Reside within the 50 states of the United States at the time of enrollment
-
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
-
Physician diagnosed myasthenia gravis
-
Physician diagnosed multiple sclerosis
-
Have speech impairment, eye/arm/leg weakness due to physician diagnosed brain cancer, or stroke