Safer Food Allergy Management for Adolescents
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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간섭 없음: 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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간섭 없음: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of check-ins at which participant is carrying epinephrine auto-injector
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Characterize adolescents' normative food allergy management practices
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Carolyn C Cannuscio, ScD, University of Pennsylvania
- 수석 연구원: Jonathan Spergel, MD, Children's Hospital of Philadelphia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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