Patient and Caregiver Quality of Life in the Treatment of Atopic Dermatitis in Pediatric Patients: a Comparison Between a General Pediatric Practice and a Pediatric Dermatology Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in quality of life of patients
研究概览
简要总结
The purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD).
详细描述
Hypothesis:
We hypothesize that on average, the patients treated by the general pediatrician will have a smaller increase in quality of life at the end of the 2-week treatment period when compared to patients treated by the specialist.
Methods:
The primary endpoint will be the difference in patient and caregiver quality of life from baseline for the group treated by the general pediatrician and the group treated by the pediatric dermatologist. Secondary endpoints will be the difference in atopic dermatitis severity and TCS phobia from baseline.
Patients will be recruited from the Yale Pediatric Dermatology Clinic and Long Wharf Pediatrics and Adolescent Medicine in New Haven, CT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the clinical criteria for the diagnosis of atopic dermatitis
- •Have disease over at least 5% of their total body surface area.
- •Less than 7 years of age.
- •Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
- •Parents/guardians able to understand and willing to sign a parental permission form.
排除标准
- •Clinically infected atopic dermatitis.
- •Lack of follow-up after initial visit or regimen non-adherence.
- •Patients who are allergic or intolerant of the topical medications employed in this study.
结局指标
主要结局
Change in quality of life of patients
时间窗: 2 weeks
Measured using Infant's Dermatitis Quality of Life Index (IDQoL) or Children's Dermatology Life Quality Index(CDLQI) depending on age
次要结局
- Change in quality of life of patient caregivers(2 weeks)
- Change in topical corticosteroid phobia in caregivers(2 weeks)
- Change in clinical severity of atopic dermatitis(2 weeks)