Safer Food Allergy Management for Adolescents
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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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介入なし：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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介入なし：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of check-ins at which participant is carrying epinephrine auto-injector
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Characterize adolescents' normative food allergy management practices
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Carolyn C Cannuscio, ScD、University of Pennsylvania
- 主任研究者：Jonathan Spergel, MD、Children's Hospital of Philadelphia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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