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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2020

Detailed Description

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.

Interventions

  • Other: CAPTURE Tool
    • CAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements

Arms, Groups and Cohorts

  • Participants without a diagnosis of COPD
    • Men and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
    • Time Frame: 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.

Secondary Measures

  • 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.
    • Time Frame: Baseline
    • Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with COPD across sex, ethnic groups, urban vs rural location, and educational status.
  • Positive and negative predictive values (PPV and NPV) in different practice settings
    • Time Frame: Baseline
    • Positive and negative predictive values in different practice settings
  • 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
    • Time Frame: Baseline
    • AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for clinically significant COPD screen.
  • AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
    • Time Frame: Baseline
    • AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
  • Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at baseline
    • Time Frame: 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.
  • 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.
    • Time Frame: 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. Spirometrically defined COPD is defined as post-bronchodilator FEV1/FVC < 0.70
  • 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
    • Time Frame: Baseline
    • AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for spirometrically defined COPD (FEV1/FVC < 0.70) screen.
  • AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD
    • Time Frame: Baseline
    • AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD (FEV1/FVC < 0.70).
  • Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline
    • Time Frame: 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.
  • Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.
    • Time Frame: 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. 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.
  • 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
    • Time Frame: Baseline
    • 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.
  • AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD
    • Time Frame: Baseline
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 45-80 years

Exclusion Criteria

1. Previous clinician provided diagnosis of COPD

2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days of baseline

3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days of baseline

1. Chest surgery

2. Abdominal surgery

3. Eye surgery

4. Heart attack

5. Stroke

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fernando J Martinez, MD, MS, Principal Investigator, Weill Cornell Medicine
    • MeiLan Han, Principal Investigator, University of Michigan
  • Overall Contact(s)
    • Fernando J Martinez, MD, MS, 646-962-2748, fjm2003@med.cornell.edu

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