VISN 23 Lung Disease Self Management/Case Management Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 743
- 试验地点
- 10
- 主要终点
- Hospitalization or Emergency Department Visit for COPD
研究概览
简要总结
The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).
详细描述
Study design and plan:
This is a one-year, 5-site randomized trial. High-risk patients will be randomized to usual care or a case/self management intervention. The frequency of urgent care visits or admission to a hospital for COPD will be compared.
Study procedures: visit 1 Patient informed consent will be obtained prior to patient participation in the trial.
Patients will also sign a release of information form to obtain outside records of COPD admissions or urgent care visits.
Demographic data, inclusion/exclusion data, medications and problem list will be obtained.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more of the following:
- •Hospital admission for COPD within the prior year
- •Unscheduled visit for COPD within the prior year
- •Home oxygen use for COPD
- •Systemic steroid use for COPD within the prior year
- •Post bronchodilator FEV1 < 70% predicted
- •Post bronchodilator FEV1/FVC < 70% predicted
排除标准
- •Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to < 1 year
- •Inability to contact patient by telephone
结局指标
主要结局
Hospitalization or Emergency Department Visit for COPD
时间窗: 1 yr
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)
时间窗: 1 yr
次要结局
- All Cause Hospitalizations(1 year)
- Quality of Life(1 year)
- COPD Exacerbations Requiring Antibiotics or Corticosteroids(1 year)
- All Cause Mortality(1 year)