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临床试验/NCT01914978
NCT01914978已完成不适用

Living Confidently With Food Allergy: Evaluating the Effectiveness of a Handbook for the Newly Diagnosed

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年7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
180
试验地点
2
主要终点
Change in food allergy-specific quality of life score

研究概览

简要总结

The objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. The handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. Parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). Participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome measures and satisfaction with the handbook. Parents in the control group will receive the handbook following the conclusion of their participation in the study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents of children ages 0 to 18 years newly diagnosed with food allergy (within the past 12 months)
  • Child's food allergy has been diagnosed by a physician
  • Child has been prescribed an epinephrine auto-injector

排除标准

  • Non-English speakers, as the handbook (study intervention) is only available in English at this time.

结局指标

主要结局

Change in food allergy-specific quality of life score

时间窗: 2 week and 2-month follow-up

Food Allergy-specific quality of life measured on the Food Allergy Quality of Life-Parental Burden Questionnaire (total score)

次要结局

  • Changes in food allergy knowledge score(2-week and 2-month follow-up)
  • Change in confidence in allergy management skills score(2-week and 2-month follow-up)
  • Change in food allergy outcome expectations score(2-week and 2-month follow-up)
  • Parent satisfaction with study handbook (study intervention)(2-week follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer LeBovidge

Psychologist

Boston Children's Hospital

研究点 (2)

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