Self-injection and Self-management

Food Allergy Clinical Trial

Official title:

Epinephrine Self-injection and Self-management of Food Allergies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417493
• Other study ID #: GCO 15-0140
• Secondary ID: 02662242 - 4606
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: June 30, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

Intervention

Behavioral:
• Simulation of epinephrine self-injection

Locations

Country	Name	City	State
United States	Jaffe Food Allergy Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Fordham University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No