Living Confidently With Food Allergy: Evaluating the Effectiveness of a Handbook for the Newly Diagnosed
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
- 否
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
Jennifer LeBovidge
Psychologist
Boston Children's Hospital
