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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03581227
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), University of Michigan (Other), National Jewish Health (Other), University of Minnesota (Other), Duke University (Other), Wake Forest University Health Sciences (Other), Oregon Health and Science University (Other), High Plains Research Network (Other), L.A. Net Community Health Resource Network (Other), COPD Foundation (Other), University of Kentucky (Other)
• Enrollment: 4,679
• Locations: 8
• Actual Duration (Months): 45
• Patients Per Site: 584.9
• Patients Per Site Per Month: 13

Study Details

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	Phase
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: Jul 1, 2018
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	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 [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.

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. [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 [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 [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 [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 [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. [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 [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 [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 [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. [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 [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 [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

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

4. Chest surgery

5. Abdominal surgery

6. Eye surgery

7. Heart attack

8. Stroke

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LANet	Los Angeles	California	United States	90802
2	High Plains Research Network	Aurora	Colorado	United States	80054
3	COPD Foundation	Miami	Florida	United States	33134
4	Cook County Health	Chicago	Illinois	United States	60612
5	University of Illinois at Chicago	Chicago	Illinois	United States	60612
6	Atrium Healthcare	Charlotte	North Carolina	United States	28207
7	Duke University	Durham	North Carolina	United States	27701
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03581227
• Other Study ID Numbers: 1803019032-1; R01HL136682-01
• First Posted: Jul 10, 2018
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 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

Study Results

No Results Posted as of Jul 29, 2022