Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,066
- 试验地点
- 3
- 主要终点
- Phase 1 identifies the demographic & genetic factors affecting inpatient hospitalization for COPD exacerbation.Phase 2 documents the number of physician & ER visits, hospitalizations & death related to exacerbations.
研究概览
简要总结
The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.
详细描述
- Overall objective: To determine why African American and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for COPD-and to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention--access to a 1-800 Temple Call Center phone number where patients can get immediate customized advice on managing COPD exacerbations in their early stages.
- Phase 1: To compare and contrast the influence of race and geographic location in COPD exacerbation in relation to severity, comorbidities, treatment patterns, infection rate. To identify potential risk factors for COPD exacerbations leading to hospitalization.
- Phase 2: To reduce hospitalizations and deaths due to COPD exacerbations and to improve patient quality of life, lung function, and everyday activity levels
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation
- •Phase 1 & 2: COPD & ONE of the following criteria:
- •History of hospitalization for COPD exacerbation, OR
- •Currently on supplemental oxygen, OR
- •History of evaluation for lung transplant or LVRS, OR
- •>/= 6 months post-LVRS
- •Phase 1 or 2:
- •Current or former smoker, >/= 20 pack-yr. smoking history
- •FEV1 </= 70%; FEV1/FVC </= 70%
- •Life expectancy of > 6 months
排除标准
- •< 20 pack-yr. smoking history
- •Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass
- •FEV1 > 70% or FEV1/FVC >70%
结局指标
主要结局
Phase 1 identifies the demographic & genetic factors affecting inpatient hospitalization for COPD exacerbation.Phase 2 documents the number of physician & ER visits, hospitalizations & death related to exacerbations.
时间窗: Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.
次要结局
- Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.(2 years)