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Safer Food Allergy Management for Adolescents

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ClinicalTrials.gov Identifier: NCT03284372
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Food Allergy Adherence, Medication Behavioral: Text Message Only Behavioral: Text message + Incentive 1 Behavioral: Text message + Incentive 2 Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safer Food Allergy Management for Adolescents
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention 1
Text Message Only
Behavioral: Text Message Only
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.

Experimental: Intervention 2, Incentive 1
Text message + Incentive 1
Behavioral: Text message + Incentive 1
Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=25) 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.

Experimental: Intervention 2, Incentive 2
Text message + Incentive 2
Behavioral: Text message + Incentive 2
Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=25) to receive text message reminders plus Incentive 2 (at each of 10 check-in, successful participants will have a 2/5 chance of winning a small prize or a 2/25 chance of winning a bigger prize). The remainder of the Cohort (control) will receive text reminders.

No Intervention: 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.
No Intervention: 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.
No Intervention: 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.



Primary Outcome Measures :
  1. Proportion of check-ins at which participant is carrying epinephrine auto-injector [ Time Frame: 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


Secondary Outcome Measures :
  1. Characterize adolescents' normative food allergy management practices [ Time Frame: Year-long cohort study ]
    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.

  2. Characterize adolescents' normative food allergy management practices [ Time Frame: Year-long cohort study ]
    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.

  3. Develop a set of text message reminders to promote safer food allergy management among adolescents [ Time Frame: 2-year project period ]
    Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284372


Contacts
Contact: Carolyn C Cannuscio, ScD 215.746.4175 cannusci@wharton.upenn.edu
Contact: Xochitl Luna Marti 215.746.3881 xochitl@sas.upenn.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jonathan Spergel, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Carolyn C Cannuscio, ScD    215-746-4175    cannusci@wharton.upenn.edu   
Contact: Roxanne Dupuis, MSPH    215.573.6917    rdupuis@mail.med.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Carolyn C Cannuscio, ScD University of Pennsylvania
Principal Investigator: Jonathan Spergel, MD Children's Hospital of Philadelphia

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03284372     History of Changes
Other Study ID Numbers: 827073
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents