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

• ClinicalTrials.gov Identifier: NCT03581227
• Recruitment Status: Completed
• First Posted: July 10, 2018
• Last Update Posted: November 4, 2022
• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Michigan; National Jewish Health; University of Minnesota; Duke University; Wake Forest University Health Sciences; Oregon Health and Science University; High Plains Research Network; L.A. Net Community Health Resource Network; COPD Foundation; University of Kentucky
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD)	Other: CAPTURE Tool

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 4679 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: April 1, 2022
• Actual Study Completion Date: April 1, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Participants without a diagnosis of COPD; Men and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)	Other: CAPTURE Tool; CAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Adult men and women recruited from a broad range of primary care settings across the United States.

Criteria

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

Contacts and Locations

Locations

United States, California

LANet

Los Angeles, California, United States, 90802

United States, Colorado

High Plains Research Network

Aurora, Colorado, United States, 80054

United States, Florida

COPD Foundation

Miami, Florida, United States, 33134

United States, Illinois

Cook County Health

Chicago, Illinois, United States, 60612

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

United States, North Carolina

Atrium Healthcare

Charlotte, North Carolina, United States, 28207

Duke University

Durham, North Carolina, United States, 27701

United States, Oregon

Oregon Rural Practice-based Research Network (ORPRN)

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Weill Medical College of Cornell University

National Heart, Lung, and Blood Institute (NHLBI)

University of Michigan

National Jewish Health

University of Minnesota

Duke University

Wake Forest University Health Sciences

Oregon Health and Science University

High Plains Research Network

L.A. Net Community Health Resource Network

COPD Foundation

University of Kentucky

Investigators

• Principal Investigator: Fernando J Martinez, MD, MS; Weill Medical College of Cornell University
• Principal Investigator: MeiLan Han; University of Michigan

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03581227
• Other Study ID Numbers: 1803019032-1; R01HL136682-01 ( U.S. NIH Grant/Contract )
• First Posted: July 10, 2018
• Last Update Posted: November 4, 2022
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:

CAPTURE, COPD

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases