Safer Food Allergy Management for Adolescents

University of Pennsylvania

Status: Completed

Conditions: Food Allergy; Adherence, Medication

Treatments: Behavioral: Text Message Only; Behavioral: Text message + Incentive 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03284372

827073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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138 participants in 5 patient groups

Intervention 1

Experimental group

Description:

Text Message Only

Treatment:

Behavioral: Text Message Only

Intervention 2, Incentive

Experimental group

Description:

Text message + Incentive

Treatment:

Behavioral: Text message + Incentive 1

Cohort

No Intervention group

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.

Control

No Intervention group

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.

Adolescent Allergy Advisors

No Intervention group

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.