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临床试验/NCT06180577
NCT06180577已完成不适用

A Retrospective Survey Study to Assess the Accessibility, Preference, and Frequency of Adolescents Using Nerivio in School Setting

Theranica1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2024年2月1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
332
试验地点
1
主要终点
Nerivio usage at school

研究概览

简要总结

This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once. The study will be conducted electronically, and will include eligibility questions, an electronic informed consent form signed by the parent/legal guardian (e-ICF), an assent form signed by the adolescent patient (e-Assent), and an e-survey relating to the management of headaches due to migraine attacks. Participants will be recruited from Nerivio's userbase and will be compensated for their participation.

详细描述

This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once.

Study group: Participants will be recruited from Nerivio's user database. An invitation message will be sent via emails and/or in-app notifications to Nerivio users who are (1) under the age of 18 years old, and (2) treated with Nerivio at least once. Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility.

Adolescents who are found eligible will be offered the opportunity to participate in the study. If they are willing, they will first be directed to an Informed Consent Form (e-ICF) to be signed by the participant's parent/legal guardian. A copy of the completed form will be automatically sent to the parent/legal guardian upon completion. If the parent/legal guardian consents via the e-ICF to his/her child's participation, an electronic assent form will follow and must be signed by the adolescent patient. A copy of the assent form will be automatically sent to the parents and the adolescent patient. Once both electronic consent forms are signed, the adolescent patient will be enrolled in the study and will be directed to the study survey.

Primary outcome measures:

Percent of adolescents' who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).

研究设计

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

入排标准

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

入选标准

  • Age ≤18 years old at registration to the Nerivio app
  • Treated with Nerivio at least once (≥30 minutes/treatment).
  • Attended elementary, middle, junior high, or high school, while first prescribed Nerivio
  • Must obtain parent/legal guardian consent form prior to signing the assent form by the adolescent and engaging in study survey.

排除标准

  • 未提供

结局指标

主要结局

Nerivio usage at school

时间窗: 1 year

Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).

次要结局

  • Limitations to migraine treatment at school(1 year)
  • Types of migraine treatments during school(1 year)

研究者

发起方
Theranica
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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