Validation and Scaling of Screening Program for Undiagnosed Myasthenia Gravis-Social Media Campaign Paired With a Self-moderated Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZS Associates

About this trial

This study expands and validates the pilot study NCT06381284. It is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The primary objective is to determine the validity of a self-assessment tool in encouraging undiagnosed participants, recruited through a social media campaign, to seek medical evaluation for suspected myasthenia gravis (MG).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Live in an overseas territory of the United States

Inability or unwillingness to provide written informed consent

Diagnosed myasthenia gravis, including sero-negative MG*

Diagnosed multiple sclerosis

Trial population

Adult participants who have undiagnosed neuromuscular symptoms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Social media recruitment

    Behavioral

    Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment

  • Self-Assessment

    Behavioral

    Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups

  • Follow-up

    Behavioral

    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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Participants with undiagnosed neuromuscular symptoms3 interventions

Trial outcomes

Primary outcomes

1

Self-Assessment tool validity

Measure the specificity and sensitivity of the Self-Assessment tool

Time frame
6 months from time of enrollment

Secondary outcomes

1

Social media engagement

Measure the engagement and cost metrics of the social media ad campaign

Time frame
Enrollment period (~4-5 months)

Other outcomes

1

Time to diagnosis

Evaluate the time to diagnosis for any participant who has a new diagnosis of MG after completing the study

Time frame
6 months from time of enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ZS Associates

Lead sponsor

UCB Pharma

Collaborator

University of California, San Francisco

Collaborator