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临床试验/NCT03284372
NCT03284372已完成不适用

Safer Food Allergy Management for Adolescents

University of Pennsylvania4 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
4
主要终点
Proportion of check-ins at which participant is carrying epinephrine auto-injector

研究概览

简要总结

Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. In a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.

详细描述

Among the 15 million people with food allergies in the United States, adolescents experience the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. Despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis.

The objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. The primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies.

In a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest incentives on consistency of epinephrine carrying. Based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Food allergy diagnosis by a physician and recorded in the medical chart
  • Prior prescription of epinephrine auto-injector to treat anaphylaxis
  • Access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone)
  • Fluent in English
  • Between ages 15-19 at baseline

排除标准

  • Unable to obtain permission (consent) of a parent to participate in the study
  • Will not or cannot give assent
  • Currently participating in another clinical trial with related aims

结局指标

主要结局

Proportion of check-ins at which participant is carrying epinephrine auto-injector

时间窗: 10 randomly timed check-ins during the 10-week intervention period

Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs

次要结局

  • Develop a set of text message reminders to promote safer food allergy management among adolescents(2-year project period)
  • Characterize adolescents' normative food allergy management practices(Year-long cohort study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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