Self-injection and Self-management
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulation of epinephrine self-injection
Sponsored by
About this trial
This is an interventional supportive care trial for Food Allergy focused on measuring Food allergy, self-management, epinephrine self-injection, ntervention, adolescents
Eligibility 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.
Sites / Locations
- Jaffe Food Allergy Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Simulation of Epinephrine Self-Injection
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02417493
First Posted
April 10, 2015
Last Updated
June 30, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Fordham University
1. Study Identification
Unique Protocol Identification Number
NCT02417493
Brief Title
Self-injection and Self-management
Official Title
Epinephrine Self-injection and Self-management of Food Allergies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Fordham University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food allergy, self-management, epinephrine self-injection, ntervention, adolescents
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simulation of Epinephrine Self-Injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Simulation of epinephrine self-injection
Primary Outcome Measure Information:
Title
Child comfort with epinephrine self-injection
Description
Immediate pre-post differences within the intervention group in the score obtained on a child-reported "comfort with self-injection" questionnaire.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Child likelihood of epinephrine self-injection
Description
Immediate pre-post differences within the intervention group in the score obtained on a child-reported likelihood of self-injection questionnaire.
Time Frame
Day 1
Title
Parent report of child comfort with epinephrine self-injection
Description
Immediate pre-post differences within the intervention group in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.
Time Frame
Day 1
Title
Child comfort with epinephrine self-injection
Description
Immediate post-1 month post differences between groups in the score obtained on a child-reported "comfort with self-injection" questionnaire.
Time Frame
1 month post-intervention
Title
Parent report of child comfort with epinephrine self-injection
Description
Immediate post- 1 month post differences between groups in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.
Time Frame
1 month post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Shemesh, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaffe Food Allergy Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Self-injection and Self-management
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