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临床试验/NCT02417493
NCT02417493已完成不适用

Epinephrine Self-injection and Self-management of Food Allergies

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Child comfort with epinephrine self-injection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Child comfort with epinephrine self-injection

时间窗: Day 1

Immediate pre-post differences within the intervention group in the score obtained on a child-reported "comfort with self-injection" questionnaire.

次要结局

  • Child likelihood of 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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