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临床试验/NCT03284372
NCT03284372已完成不适用

Safer Food Allergy Management for Adolescents

University of Pennsylvania2 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
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
否

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

研究组 & 干预措施

Intervention 1

Experimental

Text Message Only

干预措施: Text Message Only (Behavioral)

Intervention 2, Incentive

Experimental

Text message + Incentive

干预措施: Text message + Incentive 1 (Behavioral)

Cohort

No Intervention

For the cohort multiple randomized controlled trial (cmRCT), investigators will recruit 130 participants (the base cohort) ages 15-19. The base cohort allows investigators to measure normative food allergy self-management practices, while also serving as a control for experiments in Interventions 1 and 2.

Control

No Intervention

The baseline cohort serves as the control group in this cmRCT. Participants will not receive text message reminders (during Intervention 1) or incentives (during Intervention 2). However, they will participate in all data collection points, including text message check-ins to assess epinephrine-carrying. Participants in the base cohort will receive usual care.

Adolescent Allergy Advisors

No Intervention

We will pilot the text messages to be used in Interventions 1 and 2 through interviews and cognitive testing among 20 Adolescent Allergy Advisors, who will critique message content, framing, and language. These advisors will not be part of the cohort multiple randomized controlled trial.

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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