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Completed

NCT Number: NCT02417493

Self-injection and Self-management

The purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaffe Food Allergy Institute

New York, 10029, United States

About this study

The purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency. Forty participants, in total, will be recruited during routine visits to an outpatient allergy clinic. Half of all participants will be randomized to the behavioral self-management intervention; whereby patients will insert a needle attached to an empty syringe into their thigh (simulating an injection of epinephrine); the other half of participants will be randomized to the control condition, and will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol. Prior to randomization, baseline measures will be collected on patient's comfort with epinephrine self-injection. Following the self-injection protocol and/or the discussion of self-injection with the physician, all participants will complete immediate post-intervention questionnaires at clinic about comfort with self-injection, health care management and anxiety. One month following the clinic visit, all patients will be sent a follow-up questionnaire that will include items identical to the ones completed at immediate post-intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients seen in the outpatient clinic and their caretakers (no inpatients).
  • Patients must have been diagnosed with food allergy and previously prescribed self-injectable epinephrine.
  • Patients between the ages of 13-17 years old.
  • Parent consent and child assent.

Exclusion criteria

  • Patients and caregiver(s) who have been diagnosed with cognitive barriers that prevent them from understanding the study, as determined by either: a previously diagnosed mental retardation or inability to repeat the study protocol at the time of consent.

Treatment and study plan

Simulation of epinephrine self-injection

Behavioral

Primary outcomes

  1. Child comfort with epinephrine self-injection

    Time frame: Day 1

    Immediate pre-post differences within the intervention group in the score obtained on a child-reported "comfort with self-injection" questionnaire.

Secondary outcomes

  1. Child likelihood of epinephrine self-injection

    Time frame: Day 1

    Immediate pre-post differences within the intervention group in the score obtained on a child-reported likelihood of self-injection questionnaire.

  2. Parent report of child comfort with epinephrine self-injection

    Time frame: Day 1

    Immediate pre-post differences within the intervention group in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.

  3. Child comfort with epinephrine self-injection

    Time frame: 1 month post-intervention

    Immediate post-1 month post differences between groups in the score obtained on a child-reported "comfort with self-injection" questionnaire.

  4. Parent report of child comfort with epinephrine self-injection

    Time frame: 1 month post-intervention

    Immediate post- 1 month post differences between groups in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Fordham University

Registry information

Official study title

Epinephrine Self-injection and Self-management of Food Allergies

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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