Duke Scleroderma Clinic Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ)
研究概览
简要总结
The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about scleroderma. This information could be used in future research to increase the understanding of disease mechanisms, treatments, and outcomes. This research may also help develop new therapies, novel measures of disease assessment or identify previously unknown manifestations of the diseases. A prospectively followed cohort is an integral component of future translational and clinical research programs. A registry for scleroderma would allow for information to be gleaned about patients in "real-world situations" in an effort to improve the reality, generalizability and applicability of information gathered.
详细描述
The Duke Scleroderma Registry (DSScR) will include 3 types of data collected at each standard of care office visit, generally every 3-6 months. The data will include:
- Clinical data obtained by clinicians and entered electronically into a secure database
- Laboratory, procedure, and imaging data obtained over the course of clinical care
- Photographs of clinically relevant physical findings.
Data that will be stored include historical data on patients' disease and concurrent medical conditions, physical exam findings, laboratory values, imaging and other diagnostic testing results, detailed list of medications and treatments, and quality of life questionnaire data. Historical information will include detailed medical, obstetric, surgical, procedural, social, and family history of disease comparable to information gathered at a typical initial visit. No protected health information will be collected or stored on family members. Data collected will be stored in a secure computer database as well as in a clinic note and will be used for patient care purposes. Protected health information (PHI) that will accompany subject data include name, medical record number, address, phone number, date of birth, dates of diagnoses, dates of procedures, and dates of clinic visits.
The database will be maintained indefinitely; there is no planned endpoint to the collection of the data and maintenance of the database as the investigators are planning a long term prospective evaluation of persons with these diseases.
Subjects will be serially approached/recruited from existing patients in the Duke Rheumatology Adult Clinic. The project will be introduced to each prospective subject by someone involved in their clinical care. A waiver of consent and Health Insurance Portability and Accountability Act (HIPAA) authorization has been filed for the Duke Scleroderma Registry. Persons who have been diagnosed with scleroderma will be identified through monitoring of outpatient clinic lists and the inpatient consult service.
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
- •Patients with a history of systemic sclerosis or Scleroderma as identified by the 2013 American College of Rheumatology classification criteria
排除标准
- 未提供
结局指标
主要结局
Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ)
时间窗: Change from baseline at 10 years
The SHAQ is a measure of health and disability that produces a discrete value that can change through time and in response to medication.
Change in disease activity as measured by Rodnan Skin Score
时间窗: Change from baseline at 10 years
The Rodnan skin score is a discrete measure of skin thickness that can change through time and in response to medication.
次要结局
未报告次要终点