Encouraging Allergic Young Adults to Carry Epinephrine

Not Applicable

Completed

• Conditions: Adherence; Food Allergy

• Registration Number: NCT02354729
• Lead Sponsor: University of Pennsylvania

Brief Summary

Fifteen million Americans suffer from food allergies. Food allergies can be life threatening; the only known life-saving treatment is epinephrine. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine. This is a pilot randomized trial to test text message reminders, with and without financial incentives, to encourage allergic young adults to carry epinephrine.

Detailed Description

Aim: We pilot tested a novel strategy to encourage young adults with food allergies to carry their epinephrine auto-injectors. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine.

Study design: This is a pilot randomized controlled trial, with a survey component. Text messaging is the mode of communication and inquiry with study participants.

Hypothesis: The intervention group, which will receive modest financial incentives for carrying epinephrine, will be more likely to demonstrate that they are carrying their epinephrine, when queried by the study team.

This study employs text messaging, along with photography, as a mode of momentary ecologic assessment, or real-time measurement of epinephrine carrying. In addition, text messaging was used as a mode of asking questions regarding food allergy knowledge and beliefs among young adults. Text messages were sent from a designated telephone (and telephone number) purchased for use in this study. We used text messaging for reminder messages, text responses, and for the participants to send photographs back to us. We converted text message data (participants responses) into a RedCap database. Our research coordinator sent and received the text messages and compiled a secure RedCap database of responses.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-08
• Study Completion: 2014-10
• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Have known food allergy
• Epinephrine auto-injector prescription
• Access to a cell phone with ability to send picture messages

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of check-ins at which participant is carrying epinephrine	10 randomly timed check-ins during the 7 week intervention period	Proportion of check-ins at which participants were successfully carrying their epinephrine, measured using cell phone photographs.

Secondary Outcome Measures

Name	Time	Method
Self-reported acceptability of text messages	Measured at the end of the 7 week intervention	Assess young adults' perspectives on text messaging as a vehicle for communicating health messages.