Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Cutaneous Dermatomyositis Disease Area and Severity Index
研究概览
简要总结
The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis.
The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL).
The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender/Age: Males or females above 18 years old
- •Diagnosis: Cutaneous Dermatomyositis
- •Subjects able to give informed consent
排除标准
- •Subjects without cutaneous DM
- •Penn employees
- •Penn students
- •Cognitively impaired persons
结局指标
主要结局
Cutaneous Dermatomyositis Disease Area and Severity Index
时间窗: through study completion, an average of 1 year
Disease severity tool
次要结局
- Skin quality of life tool(through study completion, an average of 1 year)
研究者
Victoria Werth
MD and Principal Investigator
University of Pennsylvania