The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,679
- 试验地点
- 8
- 主要终点
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
研究概览
简要总结
A prospective multi-center study to define the sensitivity and specificity of CAPTURE for identifying previously undiagnosed patients with clinically significant COPD in a broad range of primary care settings.
详细描述
The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.
For Aim 1 approximately 5,000 patients will be recruited across 100 participating primary care clinics. Eligible participants will undergo a baseline visit during which the CAPTURE tool and PEF will be obtained, as well as spirometry and other participant characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 45-80 years
排除标准
- •Previous clinician provided diagnosis of COPD
- •Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days of baseline
- •Participants unable to perform spirometry due to any of the following conditions within the past 30 days of baseline
- •Chest surgery
- •Abdominal surgery
- •Eye surgery
- •Heart attack
结局指标
主要结局
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
时间窗: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \< 0.7, plus one of the following: FEV1 \< 60% predicted, or ≥ 1 exacerbation-like event within the past 12 months. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
次要结局
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at baseline(Baseline)
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline(Baseline)
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD across sex, ethnic groups, urban vs rural location, and educational status.(Baseline)
- Positive and negative predictive values (PPV and NPV) in different practice settings(Baseline)
- Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for mild COPD screen(Baseline)
- Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for clinically significant COPD screen(Baseline)
- AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD(Baseline)
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD across sex, ethnic groups, urban vs rural location, and educational status.(Baseline)
- Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for spirometrically defined COPD screen(Baseline)
- AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD(Baseline)
- AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD(Baseline)
- Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.(Baseline)