Encouraging Allergic Young Adults to Carry Epinephrine
Primary Purpose
Adherence, Food Allergy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral Economics
Sponsored by
About this trial
This is an interventional other trial for Adherence
Eligibility Criteria
Inclusion Criteria:
- Have known food allergy
- Epinephrine auto-injector prescription
- Access to a cell phone with ability to send picture messages
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants received text messages and financial incentives after successfully documenting that they were carrying their epinephrine auto-injectors, based on principles of behavioral economics.
Participants received text messages.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Self-reported acceptability of text messages
Assess young adults' perspectives on text messaging as a vehicle for communicating health messages.
Full Information
NCT ID
NCT02354729
First Posted
January 23, 2015
Last Updated
June 13, 2018
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02354729
Brief Title
Encouraging Allergic Young Adults to Carry Epinephrine
Official Title
Using Text Messaging and Financial Incentives to Encourage Allergic Young Adults to Carry Epinephrine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Food Allergy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants received text messages and financial incentives after successfully documenting that they were carrying their epinephrine auto-injectors, based on principles of behavioral economics.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants received text messages.
Intervention Type
Other
Intervention Name(s)
Behavioral Economics
Intervention Description
Use financial incentives to promote epinephrine-carrying.
Primary Outcome Measure Information:
Title
Proportion of check-ins at which participant is carrying epinephrine
Description
Proportion of check-ins at which participants were successfully carrying their epinephrine, measured using cell phone photographs.
Time Frame
10 randomly timed check-ins during the 7 week intervention period
Secondary Outcome Measure Information:
Title
Self-reported acceptability of text messages
Description
Assess young adults' perspectives on text messaging as a vehicle for communicating health messages.
Time Frame
Measured at the end of the 7 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have known food allergy
Epinephrine auto-injector prescription
Access to a cell phone with ability to send picture messages
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn C Cannuscio, ScD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26093776
Citation
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.
Results Reference
result
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Encouraging Allergic Young Adults to Carry Epinephrine
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