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Safer Food Allergy Management for Adolescents

Primary Purpose

Food Allergy, Adherence, Medication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Only
Text message + Incentive 1
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Food Allergy

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

Intervention 1

Intervention 2, Incentive

Cohort

Control

Adolescent Allergy Advisors

Arm Description

Text Message Only

Text message + Incentive

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Characterize adolescents' normative food allergy management practices
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.
Characterize adolescents' normative food allergy management practices
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.
Develop a set of text message reminders to promote safer food allergy management among adolescents
Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content

Full Information

First Posted
September 7, 2017
Last Updated
March 22, 2021
Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03284372
Brief Title
Safer Food Allergy Management for Adolescents
Official Title
Safer Food Allergy Management for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Adherence, Medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Text Message Only
Arm Title
Intervention 2, Incentive
Arm Type
Experimental
Arm Description
Text message + Incentive
Arm Title
Cohort
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Adolescent Allergy Advisors
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text message + Incentive 1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of check-ins at which participant is carrying epinephrine auto-injector
Description
Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs
Time Frame
10 randomly timed check-ins during the 10-week intervention period
Secondary Outcome Measure Information:
Title
Characterize adolescents' normative food allergy management practices
Description
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.
Time Frame
Year-long cohort study
Title
Characterize adolescents' normative food allergy management practices
Description
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.
Time Frame
Year-long cohort study
Title
Develop a set of text message reminders to promote safer food allergy management among adolescents
Description
Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content
Time Frame
2-year project period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn C Cannuscio, ScD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Spergel, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safer Food Allergy Management for Adolescents

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