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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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adherence

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 23, 2015
    Last Updated
    June 13, 2018
    Sponsor
    University of Pennsylvania
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    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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