Skip to main content
OpenTrials
Completed

NCT Number: NCT03581227

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LANet, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAPTURE Tool

Other

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

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

  2. Positive and negative predictive values (PPV and NPV) in different practice settings

    Time frame: Baseline

    Positive and negative predictive values in different practice settings

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • COPD Foundation
  • Duke University
  • High Plains Research Network
  • L.A. Net Community Health Resource Network
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Jewish Health
  • Oregon Health and Science University
  • University of Kentucky
  • University of Michigan
  • University of Minnesota
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Acronym: CAPTURE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2018
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.