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临床试验/NCT04590716
NCT04590716已完成不适用

A Digital Health Trial That Assesses Participant-driven Data Collection Using Smartphone Modules to Characterize Myasthenia Gravis Symptoms and Develop an A.I. Model to Predict Flares

doc.ai inc1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2020年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Audiovisual recording of voice exercises to detect patterns and changes in voice and facial symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must have a documented diagnosis of Myasthenia Gravis
  • Must have ocular (eye drooping) and/or bulbar (speech) symptoms
  • Must be over the age of 18
  • Must reside in the US for the duration of the study
  • Must be able to read, understand, and write in English
  • Must have a smartphone supported by the doc.ai research app (iOS and Android)

排除标准

  • 未提供

结局指标

主要结局

Audiovisual recording of voice exercises to detect patterns and changes in voice and facial symptoms

时间窗: After enrollment, 3 months with in-app twice a week audiovisual recording of symptoms.

participants to complete the audio and visual data modules designed to capture patient MG symptoms (especially ocular and voice). e.g * Vocal e.g.: * Say "papapapa" for 4 seconds * Say "tatatatata" for 4 seconds * Say "kakakaka" 4 seconds * Say "mamamama" 4 seconds * Say "papapapa" 4 seconds * Say "buttercup, buttercup, buttercup" 4 seconds * Say "aaaahhh" and hold it as long as you can * Counting e.g.: * Look straight at the camera for 4 seconds * Count as precisely as possible from 1 to 25 while looking up * Look straight at the camera for 4 seconds The recordings will be used to detect change from baseline and any patterns that may occur. This will be used to analyze where and if different features are linked to see if a single or combined effect of the features is connected to flare frequency and/or severity.

次要结局

  • Completion of MG-Quality of Life assessment(Approximately 10 minutes each week for 3 months.)

研究者

发起方
doc.ai inc
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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