Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
There are limited objective measurements of MG symptoms as well as a dearth of data at a
 granular level of MG (myasthenia gravis) symptoms and triggers occurring longitudinally.

 This study is designed to use the strengths of mobile smartphones which enable
 participant-driven real time capture of data manually and through augmented sensors such as
 video and audio, in order to better characterize MG symptoms and flares.

 The study aims to enroll approximately 200 participants for approximately 9 months until
 analyzable data is available from at least 100 participants. Participants will complete
 in-app surveys for 3 months with, audiovisual recording of symptoms. This will take
 approximately 35 minutes per week after the initial survey.
Using their smartphones, potential participants will download the doc.ai research mobile app.
 There will be a web pre-screening link where potential participants will self-screen to see
 if they meet the basic eligibility criteria for this study. The recruitment tool for this
 trial is developed for diversity, fairness, and inclusion. With the aim to ensure diversity
 in the demographics of the trial to better understand the health needs of different
 populations. So, while some interested potential participants do qualify, they may not be
 invited into the trial due to these diversity requirements.

 Patients with myasthenia gravis (MG) who meet the inclusion criteria will be invited to join
 this digital health trial. Participants will sign the e-consent and self-enroll into the
 study. Once their eligibility is confirmed by the study team (to ensure eligibility criteria
 and validity of participant i.e. eliminate robo sign-ins) they will be asked to take a
 selfie, provide documented proof of MG diagnosis, respond to a series of survey questions
 regarding their demographics, current health, medical history, and other MG related
 information.

 Enrolled participants will have a daily brief check-in, 2 weekly check-ins and a weekly
 check-in which will include an audiovisual check-in, and will maintain an audiovisual diary
 to keep track of their symptoms, connect data, record their voice (to detect vocal symptoms:
 weakness, nasality) and take videos of their face (to detect facial symptoms: ocular, mouth
 droop) on a daily to weekly basis through the various data collecting modules in the doc.ai
 research app for the duration of their study participation. doc.ai's digital health trial
 platform will be leveraged to collect this data.

 The study aims to enroll approximately 200 participants in approximately 9 months. It is
 expected that a minimum of 100 participants will be included in the final analysis as at any
 given time there will be a lag between potential participants expressing interest in the
 study, their eligibility being assessed by the PI, and participants completing all required
 study procedures.

 At the end of their participation, participants will be asked to complete a questionnaire.
 After the participant has completed their final survey, they will be able to connect to a
 link redeemable as an Amazon.com gift card worth $250. All participants will also receive an
 end-of-trial-summary of the data that they had collected during the study. No medical advice
 or direction will be given based on this study.

 In addition, in the final survey participants will be asked if they would be willing to
 complete a usability interview after their participation in this trial has ended. This subset
 of participants invited to be part of a follow-up usability interview will include those who
 complete all study required procedures and some who may not have completed all study required
 procedures, in order to assess usability experience of the app for the duration of their
 participation. Participants will be contacted at their end of their period of participation
 until a total of 10-15 participants successfully complete the usability interview.
 Participants who successfully complete the usability interview will receive a link for a $50
 in Amazon.com gift card via the app.

 For this study the data and, audio and video recordings will be captured directly on the
 doc.ai research app and securely stored on a HIPAA compliant cloud provider (Google Cloud
 Platform).

 This data will be used to understand the patterns of symptoms and triggers in order to better
 characterize factors such as the length and timing of flares and any unique symptom patterns
 in order to create more objective measures of MG symptoms. Ultimately this data would be used
 to build a machine learning model that could predict MG symptom flares.

 Primary Objective:

 Use a collection of digital health modules on the smartphone to collect myasthenia gravis
 (MG) symptoms and triggers to better characterize symptom patterns and flares.

 Secondary Objective:

 Use the data collected to develop an A.I. model to detect and/or predict symptom flares.
Inclusion Criteria:

 1. Must have a documented diagnosis of Myasthenia Gravis

 2. Must have ocular (eye drooping) and/or bulbar (speech) symptoms

 3. Must be over the age of 18

 4. Must reside in the US for the duration of the study

 5. Must be able to read, understand, and write in English

 6. Must have a smartphone supported by the doc.ai research app (iOS and Android)

 Exclusion Criteria:

 None