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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— CAPTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581227
• Other study ID #: 1803019032-1
• Secondary ID: R01HL136682-01
• Status: Completed
• Start date: October 12, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4679
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	High Plains Research Network	Aurora	Colorado
United States	Atrium Healthcare	Charlotte	North Carolina
United States	Cook County Health	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	LANet	Los Angeles	California
United States	COPD Foundation	Miami	Florida
United States	Oregon Rural Practice-based Research Network (ORPRN)	Portland	Oregon

Sponsors (12)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with COPD across sex, ethnic groups, urban vs rural location, and educational status.	Baseline
Secondary	Positive and negative predictive values (PPV and NPV) in different practice settings	Positive and negative predictive values in different practice settings	Baseline
Secondary	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	AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for clinically significant COPD screen.	Baseline
Secondary	AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD	AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD	Baseline
Secondary	Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at 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.	Baseline
Secondary	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.	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	Baseline
Secondary	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	AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for spirometrically defined COPD (FEV1/FVC < 0.70) screen.	Baseline
Secondary	AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD	AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD (FEV1/FVC < 0.70).	Baseline
Secondary	Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at 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.	Baseline
Secondary	Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.	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.	Baseline
Secondary	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	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.	Baseline
Secondary	AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD	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.	Baseline