Self-injection and Self-management

NCT ID: NCT02417493

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Simulation of Epinephrine Self-Injection

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.

Group Type: EXPERIMENTAL

Simulation of epinephrine self-injection

Intervention Type: BEHAVIORAL

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Simulation of epinephrine self-injection

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fordham University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Shemesh, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Jaffe Food Allergy Institute

New York, New York, United States

Countries

United States

Other Identifiers

02662242 - 4606

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GCO 15-0140

Identifier Type: -

Identifier Source: org_study_id