The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3) (CAPTURE)

October 19, 2023 updated by: Weill Medical College of Cornell University

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

A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.

Study Overview

Detailed Description

This is a large prospective, multi-center study explore the impact of the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial.

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.

The study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE Tool and have research spirometry testing.

Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions:

  • Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education).
  • Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information.

A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant reported data will be collected through in-person visits, telephone and mail-based methodologies, depending upon practice site preferences and feasibility. Clinic site data will also be collected from the medical record to assess for changes in practice-level care.

Primary outcome measure changes have been made in this ClinicalTrials.gov record because a planned part of the primary outcome measure was inadvertently missing from the initial draft of the protocol. It has been added to this ClinicalTrials.gov record to align with the most recent IRB-approved protocol. Secondary outcome measure changes were initiated as driven by the literature and advances in accepted methods of management and categorization of patients with COPD. An additional secondary outcome measure was added due to the COVID-19 pandemic. The changes have been made in ClinicalTrials.gov to align with the most recent IRB-approved protocol.

Study Type

Interventional

Enrollment (Actual)

2008

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90802
        • LANet
    • Colorado
      • Aurora, Colorado, United States, 80054
        • High Plains Research Network
    • Florida
      • Miami, Florida, United States, 33134
        • COPD Foundation
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Cook County Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Circuit Clinical
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Atrium Healthcare
      • Durham, North Carolina, United States, 27701
        • Duke University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Rural Practice-based Research Network (ORPRN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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
  • 4. Able to read and speak English or Spanish

Exclusion Criteria:

  • 1. Previous clinician provided diagnosis of COPD
  • 2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days
  • 3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days

    1. Chest surgery
    2. Abdominal surgery
    3. Eye surgery
    4. Heart attack
    5. Stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPTURE + COPD Education
Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education. As the second aim address the optimal format for delivering practice CAPTURE education this will be incorporated at the sites randomized to this arm.
Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.
Active Comparator: COPD Education
Practice clinicians will receive basic COPD education only.
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of CAPTURE+ participants who meet a composite endpoint for diagnosis and management of COPD
Time Frame: Baseline to 12 months

Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of CAPTURE+ participants who are referred for or complete clinical spirometry testing
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants who are newly diagnosed with COPD
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants who are referred for or complete pulmonary rehabilitation
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants who have received a recommendation for, or administration of influenza vaccination.
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants smoking at the baseline with any components of the primary endpoint OR any of the 4 events described in the description below.
Time Frame: Baseline to 12 months

Proportion of CAPTURE+ participants currently smoking at the baseline study visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

OR

1) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who are referred for or complete clinical spirometry testing
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive a new diagnosis of COPD
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who are newly prescribed respiratory medication
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive a referral to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive a referral for, or complete pulmonary rehabilitation.
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive clinician counseling or recommendation for smoking cessation
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive a referral to a smoking cessation program
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who referral to a smoking quit line
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who receive a newly prescribed medication for smoking cessation.
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Change in COPD Assessment Test (CAT) score in CAPTURE+ participants
Time Frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Baseline to 12 months
Proportion of CAPTURE+ participants who experience exacerbations, hospitalizations, or mortality
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of participants with clinically significant COPD who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint)

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD with a referral for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD with a new diagnosis of COPD
Time Frame: Baseline to 12 months
COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD with a referral to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD with a referral for or completion of pulmonary rehabilitation.
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with spirometric COPD who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD with a new diagnosis of COPD.
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. 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 to 12 months
Proportion of participants with spirometric COPD with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. 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 to 12 months
Proportion of participants with spirometric COPD referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD who are referred for or complete pulmonary rehabilitation.
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD who receive a recommendation for or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with Mild COPD who meet any of the components of the primary endpoint
Time Frame: Baseline to 12 months

Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD referred for or completion of pulmonary rehabilitation.
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD who received a recommendation or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with preserved ratio, imparied spirometry (PRISm) who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred for or completion of clinical spirometry testing.
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) with new diagnosis of COPD.
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred for or completion of pulmonary rehabilitation.
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) who receive a recommendation for or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) referred for or completion of clinical spirometry testing.
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) referred for or completion of pulmonary rehabilitation.
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) who receive a recommendation or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of CAPTURE+ participants enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of CAPTURE+ participants enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are referred for or complete clinical spirometry testing
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are referred for or complete clinical spirometry testing
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are newly diagnosed with COPD
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are newly diagnosed with COPD
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are referred for or complete pulmonary rehabilitation
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are referred for or complete pulmonary rehabilitation
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who have received a recommendation for, or administration of influenza vaccination
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who have received a recommendation for, or administration of influenza vaccination
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who have received a recommendation for, or administration of influenza vaccination
Time Frame: Baseline to 12 months
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
Baseline to 12 months
Change in COPD Assessment Test (CAT) score in CAPTURE+ participants enrolled before March 18, 2020
Time Frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Baseline to 12 months
Change in COPD Assessment Test (CAT) score in CAPTURE+ participants enrolled after August 13, 2020
Time Frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled before March 18, 2020 who experience exacerbations, hospitalizations, or mortality
Time Frame: Baseline to 12 months

Composite endpoint

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of CAPTURE+ participants enrolled after August 13, 2020 who experience exacerbations, hospitalizations, or mortality
Time Frame: Baseline to 12 months

Composite endpoint

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 who meet any of components of the primary endpoints.
Time Frame: Baseline to 12 months

Proportion of participants with clinically significant COPD enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 who meet any of components of the primary endpoints.
Time Frame: Baseline to 12 months

Proportion of participants with clinically significant COPD enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 a new diagnosis of COPD
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with clinically significant COPD enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Baseline to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 who meet any of the components of the primary endpoint
Time Frame: Baseline to 12 months

Proportion of participants with spirometric COPD enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 who meet any of the components of the primary endpoint
Time Frame: Baseline to 12 months

Proportion of participants with spirometric COPD enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 with newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 who are referred for or complete pulmonary rehabilitation
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 who are referred for or complete pulmonary rehabilitation
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with spirometric COPD enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. 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 to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 who meet any of the components of the primary endpoint
Time Frame: Baseline to 12 months

Proportion of participants with mild COPD enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 who meet any of the components of the primary endpoint
Time Frame: Baseline to 12 months

Proportion of participants with mild COPD enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled before March 18, 2020 who received a recommendation or administration of influenza vaccination
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with mild COPD enrolled after August 13, 2020 who received a recommendation or administration of influenza vaccination
Time Frame: Baseline to 12 months
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Baseline to 12 months
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled after August 13, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 with new diagnosis of COPD
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 with new diagnosis of COPD
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 18, 2020 with a newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination
Time Frame: Baseline to 12 months
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 who meet any of the components of the primary endpoint.
Time Frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred for or completion of clinical spirometry testing
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 with a new diagnosis of COPD
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 newly prescribed respiratory medication
Time Frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.

Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 who receive a recommendation or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 who receive a recommendation or administration of influenza vaccination.
Time Frame: Baseline to 12 months
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10.
Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at baseline who received over-the-counter patches/gum for smoking cessation
Time Frame: Baseline to 12 months
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2018

Primary Completion (Actual)

April 7, 2023

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1803019032-3
  • R01HL136682-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials on COPD plus CAPTURE education and patient-level information

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