NCT02354729

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

January 23, 2015

Last Update Submit

June 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of check-ins at which participant is carrying epinephrine

    Proportion of check-ins at which participants were successfully carrying their epinephrine, measured using cell phone photographs.

    10 randomly timed check-ins during the 7 week intervention period

Secondary Outcomes (1)

  • Self-reported acceptability of text messages

    Measured at the end of the 7 week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants received text messages and financial incentives after successfully documenting that they were carrying their epinephrine auto-injectors, based on principles of behavioral economics.

Other: Behavioral Economics

Control

NO INTERVENTION

Participants received text messages.

Interventions

Use financial incentives to promote epinephrine-carrying.

Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cannuscio CC, Dupuis R, Graves A, Seymour JW, Kounaves S, Strupp E, Leri D, Frasso R, Grande D, Meisel ZF. A behavioral economics intervention to encourage epinephrine-carrying among food-allergic adults: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Sep;115(3):234-240.e1. doi: 10.1016/j.anai.2015.05.018. Epub 2015 Jun 17.

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Economics, Behavioral

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesEconomicsHealth Care Economics and Organizations

Study Officials

  • Carolyn C Cannuscio, ScD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine and Community Health

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 3, 2015

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

June 15, 2018

Record last verified: 2018-06