Self-injection and Self-management
Epinephrine Self-injection and Self-management of Food Allergies
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 1, 2016
June 1, 2016
1.3 years
April 10, 2015
June 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Child likelihood of epinephrine self-injection
Day 1
Parent report of child comfort with epinephrine self-injection
Day 1
Child comfort with epinephrine self-injection
1 month post-intervention
Parent report of child comfort with epinephrine self-injection
1 month post-intervention
Study Arms (2)
Simulation of Epinephrine Self-Injection
EXPERIMENTALThe 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.
Control Group
NO INTERVENTIONThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- Fordham Universitycollaborator
Study Sites (1)
Jaffe Food Allergy Institute
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eyal Shemesh, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 15, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 1, 2016
Record last verified: 2016-06