Safer Food Allergy Management for Adolescents
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention 1
Text Message Only
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The intervention group (n=25, randomly selected from the base cohort) will receive informational and socially supportive text messages during a 10-week intervention.
Investigators will deploy the intervention using the Way to Health platform, which automates outgoing messages and feedback.
Many of the messages will be sent to all Intervention 1 participants, to assure consistency of the intervention.
A subset will be tailored to address participants' specific allergies.
At 10 unannounced check-ins, we will send text messages asking participants in the intervention and control groups if they are carrying their epinephrine.
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实验性的：Intervention 2, Incentive
Text message + Incentive
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Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=50) to receive text message reminders plus Incentive 1.
At each of 10 unannounced check-ins, if unsuccessful in documenting epinephrine-carrying, participants will lose part of their incentive.
The remainder of the Cohort (control) will receive text reminders.
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无干预：Cohort
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.
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无干预：Control
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.
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无干预：Adolescent Allergy Advisors
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Proportion of check-ins at which participant is carrying epinephrine auto-injector
大体时间：10 randomly timed check-ins during the 10-week intervention period
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Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs
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10 randomly timed check-ins during the 10-week intervention period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Characterize adolescents' normative food allergy management practices
大体时间：Year-long cohort study
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Characterize adolescents' normative food allergy management practices, measured comparing baseline and follow-up surveys that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
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Year-long cohort study
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Characterize adolescents' normative food allergy management practices
大体时间：Year-long cohort study
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Characterize adolescents' normative food allergy management practices, measured using periodic text-message questions that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
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Year-long cohort study
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Develop a set of text message reminders to promote safer food allergy management among adolescents
大体时间：2-year project period
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Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content
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2-year project period
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合作者和调查者
调查人员
- 首席研究员：Carolyn C Cannuscio, ScD、University of Pennsylvania
- 首席研究员：Jonathan Spergel, MD、Children's Hospital of Philadelphia
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Text Message Only的临床试验
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Thomas Jefferson University完全的
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University of MichiganNational Institute of Mental Health (NIMH)完全的
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University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Omnicare Clinical Research; Qualidigm完全的
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Arizona State UniversityCalifornia Polytechnic State University-San Luis Obispo完全的
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University of Georgia招聘中消息曝光（顺序：Regular Then Flavor） | 消息曝光（顺序：Flavor Then Regular） | 无消息暴露（控制条件）美国
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University of PittsburghThe Grable Foundation; The Shear Family Foundation; Heinz Endowments主动，不招人