Clinical trial NCT02417493: Self-injection and Self-management
Official title: Epinephrine Self-injection and Self-management of Food Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Food allergy
self-management
epinephrine self-injection
ntervention
adolescents
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Fordham University
First posted: 2015-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Child comfort with epinephrine self-injection
timeFrame: Day 1
Secondary outcomes:
measure: Child likelihood of epinephrine self-injection
timeFrame: Day 1
measure: Parent report of child comfort with epinephrine self-injection
timeFrame: Day 1
measure: Child comfort with epinephrine self-injection
timeFrame: 1 month post-intervention
measure: Parent report of child comfort with epinephrine self-injection
timeFrame: 1 month post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Jaffe Food Allergy Institute
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
References: