Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 02662242 - 4606 | Other Grant/Funding Number | EMPOWER Program, Mount Sinai Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fordham University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation of Epinephrine Self-Injection | Experimental | 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. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulation of epinephrine self-injection | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Parent report of child comfort with epinephrine self-injection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eyal Shemesh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaffe Food Allergy Institute | New York | New York | 10029 | United States |
Not provided
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Immediate pre-post differences within the intervention group in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire. |
| Day 1 |
| 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. | 1 month post-intervention |
| 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. | 1 month post-intervention |