Self-injection and Self-management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epinephrine Self-injection and Self-management of Food Allergies

Conditions
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Food Allergy

Intervention / Treatment
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* Behavioral: Simulation of epinephrine self-injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulation of Epinephrine Self-Injection<br>The patient will self-inject an empty syringe into his/her thigh simulating a self-injection of epinephrine during a routine outpatient visit to the allergist. | Behavioral: Simulation of epinephrine self-injection<br> <br> |
| No Intervention: Control Group<br>The patient will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol during a routine outpatient visit to the allergist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child comfort with epinephrine self-injection | Immediate pre-post differences within the intervention group in the score obtained on a child-reported comfort with self-injection questionnaire. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child likelihood of epinephrine self-injection | Immediate pre-post differences within the intervention group in the score obtained on a child-reported likelihood of self-injection questionnaire. | Day 1 | 
| Parent report of child comfort with epinephrine self-injection | Immediate pre-post differences within the intervention group in the score obtained on a parent-reported child's comfort with self-injection questionnaire. | Day 1 | 
| Child comfort with epinephrine self-injection | Immediate post-1 month post differences between groups in the score obtained on a child-reported comfort with self-injection questionnaire. | 1 month post-intervention | 
| Parent report of child comfort with epinephrine self-injection | Immediate post- 1 month post differences between groups in the score obtained on a parent-reported child's comfort with self-injection questionnaire. | 1 month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food allergy, adolescents, self-management, epinephrine self-injection, ntervention