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临床试验/NCT01143012
NCT01143012已完成不适用

Group Eczema Education Visits:Impact on Patient and Family Quality of Life

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
The difference between the two groups in CADIS score

研究概览

简要总结

The objective of this study is to determine whether group educational visits improve the quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to determine whether group educational visits influences other key elements of patient care such as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the office. Lastly, the investigators hope to evaluate which aspects of the educational visit were found to be the most helpful to families caring for children with atopic dermatitis (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric dermatology clinics. All consecutive patients with such appointments during a three month time period will be screened for participation in the study. Parents will be recruited via telephone. In the intervention group, parents will be invited to participate in a group education visit prior to their first appointment with a dermatologist. All parents in the study will fill out questionnaires. The children involved in the study will be assigned an eczema severity score during their routine visits, but this will be incorporated into the regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the quality of life in households with children who have atopic dermatitis. The Eczema Area and Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis. The change in CADIS scores will be analyzed to determine if there is a more significant improvement in quality of life for the group in which parents receive the group eczema education visit.

研究设计

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

入排标准

年龄范围
2 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 2 months though 6 years.
  • Participants must carry a diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
  • New patients or consultations at an OHSU clinic.
  • English-speaking families will be included in this study

排除标准

  • Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)

研究组 & 干预措施

Group eczema education session

Active Comparator

One group will attend a group eczema education session. All subjects will answer quality of life questions two times.

干预措施: Group eczema education session (Other)

Control group

Active Comparator

The other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times.

干预措施: Control group (Other)

结局指标

主要结局

The difference between the two groups in CADIS score

时间窗: 4 weeks

The primary outcome will be the difference between the two groups in CADIS score as measured at four weeks. CADIS is a validated outcome of pediatric quality of life in AD.

次要结局

  • Assess extent of skin disease.(Between 4 weeks and 4 months of the first visit.)
  • Assess average monthly number of follow-up phone calls.(Between 4 weeks and 4 months of the first visit.)
  • Assess average monthly number of urgent and emergency visits.(Between 4 weeks and 4 months of the first visit.)

研究者

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

Susan Tofte

Principal Investigator

Oregon Health and Science University

研究点 (2)

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