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

NCT03581227 | Completed DMC

• 2 other identifiers: 1803019032-1R01HL136682-01
• Study Type: observational
• Target: 4,679
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

CAPTURE, COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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 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 at baseline

  Baseline

Study Arms (1)

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

Interventions

CAPTURE Tool OTHER

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

Participants without a diagnosis of COPD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

LANet

Los Angeles, California, 90802, United States

Location

High Plains Research Network

Aurora, Colorado, 80054, United States

Location

COPD Foundation

Miami, Florida, 33134, United States

Location

Cook County Health

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Atrium Healthcare

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Oregon Rural Practice-based Research Network (ORPRN)

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Martinez FJ, Yawn BP, Angulo D, Lopez C, Murray S, Mannino D, Anderson S, Dolor R, Elder N, Joo M, Khan I, Knox LM, Meldrum C, Peters E, Spino C, Tapp H, Thomashow B, Zittleman L, Brown R, Make B, Han MK; CAPTURE Study Group. Impact of the CAPTURE Chronic Obstructive Pulmonary Disease Screening Tool in U.S. Primary Care: A Cluster-Randomized Trial. Am J Respir Crit Care Med. 2025 May;211(5):789-802. doi: 10.1164/rccm.202405-0921OC.

  PMID: 39715575 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando J Martinez, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• MeiLan Han

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: October 12, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

US (8)