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Self-injection and Self-management

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Food Allergy

Intervention: Simulation of epinephrine self-injection (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Icahn School of Medicine at Mount Sinai

Official(s) and/or principal investigator(s):
Eyal Shemesh, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai

Overall contact:
Eyal Shemesh, MD, Phone: 212-241-6710, Email: eyal.shemesh@mssm.edu

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.

Clinical Details

Official title: Epinephrine Self-injection and Self-management of Food Allergies

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

Primary outcome: Child comfort with epinephrine self-injection

Secondary outcome:

Child likelihood of epinephrine self-injection

Parent report of child comfort with epinephrine self-injection

Child comfort with epinephrine self-injection

Parent report of child comfort with epinephrine self-injection

Detailed 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.

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Eyal Shemesh, MD, Phone: 212-241-6710, Email: eyal.shemesh@mssm.edu

Jaffe Food Allergy Institute, New York, New York 10029, United States; Recruiting
Scott H. Sicherer, MD, Phone: 212-241-5548, Email: scott.sicherer@mssm.edu
Additional Information

Starting date: March 2015
Last updated: April 10, 2015

Page last updated: August 20, 2015

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