The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 1)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: CAPTURE Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Stroke

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants without a diagnosis of COPD<br>Men and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) | Other: CAPTURE Tool<br>* CAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with 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 | Positive and negative predictive values 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 clinically significant COPD screen | AUC for various cutpoints of CAPTURE and PEF 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 | 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 at baseline | Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with Spirometrically defined COPD at baseline. Spirometrically defined COPD is defined as post-bronchodilator FEV1/FVC < 0.70. | 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. | 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. Spirometrically defined COPD is defined as post-bronchodilator FEV1/FVC < 0.70 | 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 | AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for spirometrically defined COPD (FEV1/FVC < 0.70) screen. | Baseline | 
| AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD | AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD (FEV1/FVC < 0.70). | Baseline | 
| Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline | Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation. | 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. | Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation. | 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 | AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for mild COPD screen. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation. | Baseline | 
| AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD | AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAPTURE, COPD