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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: CAPTURE Tool

• Registration Number: NCT03581227
• Lead Sponsor: Weill Medical College of Cornell University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-10
• Study Start: 2018-10-12
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4679

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline	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

Name	Time	Method
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	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	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 mild COPD screen	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.
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 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	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 across sex, ethnic groups, urban vs rural location, and educational status.	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	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 mild COPD	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.
AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD	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 spirometrically defined COPD at baseline	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 mild COPD at baseline	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.	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.

Trial Locations

Locations (8)

High Plains Research Network; 🇺🇸 Aurora, Colorado, United States

LANet; 🇺🇸 Los Angeles, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Oregon Rural Practice-based Research Network (ORPRN); 🇺🇸 Portland, Oregon, United States

COPD Foundation; 🇺🇸 Miami, Florida, United States

Cook County Health; 🇺🇸 Chicago, Illinois, United States

Atrium Healthcare; 🇺🇸 Charlotte, North Carolina, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States