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临床试验/NCT06381284
NCT06381284已完成不适用

Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment

ZS Associates1 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2024年3月28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
215
试验地点
1
主要终点
Social media recruitment feasibility

研究概览

简要总结

This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. 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).

详细描述

Participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). 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 don't 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 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 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 neurologist's 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.

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

  • 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

排除标准

  • Live in an overseas territory of the United States
  • Inability or unwillingness to provide written informed consent
  • Diagnosed myasthenia gravis
  • Diagnosed multiple sclerosis
  • Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke

结局指标

主要结局

Social media recruitment feasibility

时间窗: Enrollment period (4-6weeks)

Measure the engagement and feasibility metrics of the social media campaign

次要结局

  • MG Exercise Assessment Tool validity(1 year from time of enrollment)

研究者

发起方
ZS Associates
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Ananda Vishnu Pandurangadu, MD

Senior Consultant

ZS Associates

研究点 (1)

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