The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3) (CAPTURE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03583099 |
Recruitment Status :
Recruiting
First Posted : July 11, 2018
Last Update Posted : March 13, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) | Other: COPD plus CAPTURE education and patient-level information Other: COPD Education Only | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participating primary practices will be randomized to one of 2 arms.
|
Masking: | Double (Participant, Care Provider) |
Masking Description: | Practitioners at sites randomized to the COPD education only intervention will be blinded to CAPTURE scores. Practitioners in both intervention arms will be blinded to research spirometry results. Participants will be blinded to spirometry results. |
Primary Purpose: | Other |
Official Title: | The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care |
Actual Study Start Date : | September 17, 2018 |
Estimated Primary Completion Date : | July 1, 2021 |
Estimated Study Completion Date : | July 1, 2021 |

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.
|
Other: COPD plus CAPTURE education and patient-level information
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.
|
Other: COPD Education Only
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided. |
- 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), or 4) referral to a specialist for respiratory evaluation/treatment 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
- Proportion of CAPTURE+ participants who are referred for or completion of clinical spirometry testing [ Time Frame: Baseline to 12 months ]Proportion of CAPTURE+ participants who are referred for or completion of clinical spirometry testing
- Proportion of CAPTURE+ participants who are newly diagnosed with COPD [ Time Frame: Baseline to 12 months ]Proportion of CAPTURE+ participants who are newly diagnosed with COPD
- Proportion of CAPTURE+ participants with newly prescribed respiratory medication [ Time Frame: Baseline to 12 months ]Proportion of CAPTURE+ participants with newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition)
- Proportion of CAPTURE+ participants referred to a specialist for respiratory evaluation/treatment [ Time Frame: Baseline to 12 months ]Proportion of CAPTURE+ participants referred to a specialist for respiratory evaluation/treatment.
- Incidence of physician referral to a formal smoking cessation program in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician referral to a formal smoking cessation program in subjects with clinically significant COPD, defined as post-bronchodilator forced expiratory volume at 1 second/forced vital capacity (FEV1/FVC) < 0.7, plus one of the following: FEV1 < 60% predicted, or > 1 exacerbation-like event within the past 12 months, and are current smokers.
- Incidence of physician referral to pulmonary rehabilitation program in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician referral to pulmonary rehabilitation program in subjects with clinically significant COPD and are current smokers, 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, and are current smokers
- Incidence of physician prescribed smoking cessation medication in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician prescribed smoking cessation medication in subjects with clinically significant COPD, 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, and are current smokers
- Incidence of physician referral to a formal smoking cessation program in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician referral to a formal smoking cessation program in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70)
- Incidence of physician prescribed smoking cessation medication in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician prescribed smoking cessation medication in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70) and are current smokers
- Incidence of physician referral to pulmonary rehabilitation program in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]Incidence of physician referral to pulmonary rehabilitation program in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70) and are current smokers
- Change in COPD Assessment Test (CAT) score in participants with clinically significant COPD [ Time Frame: Baseline to 12 months ]Change in CAT score in participants with clinically significant COPD
- Change in COPD Assessment Test (CAT) score in participants with spirometrically defined COPD [ Time Frame: Baseline to 12 months ]Change in COPD Assessment Test (CAT) score in participants with spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.70)
- Proportion of participants with clinically significant COPD who experience exacerbations, hospitalizations, or mortality [ Time Frame: Baseline to 12 months ]Proportion of participants with clinically significant COPD who experience exacerbations, hospitalizations, or mortality
- Proportion of participants with spirometrically defined COPD who experience exacerbations, hospitalizations, or mortality [ Time Frame: Baseline to 12 months ]Proportion of participants with spirometrically defined COPD, (post-bronchodilator FEV1/FVC < 0.70) who experience exacerbations, hospitalizations, or mortality
- Proportion of participants with spirometrically defined COPD who meet a composite endpoint for diagnosis and management of COPD [ Time Frame: Baseline to 12 months ]Proportion of participants with spirometrically defined 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), or 4) referral to a specialist for respiratory evaluation/treatment 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
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
-
3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days
- Chest surgery
- Abdominal surgery
- Eye surgery
- Heart attack
- Stroke

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583099
Contact: Fernando J Martinez, MD, MS | 646-962-2748 | fjm2003@med.cornell.edu | |
Contact: Elizabeth Peters, BSN, RN | 646-962-2742 | elp2018@med.cornell.edu |
United States, California | |
LANet | Recruiting |
Los Angeles, California, United States, 90802 | |
Contact: Lyndee Knox, PhD 562-434-2000 lyndee.knox@gmail.com | |
United States, Colorado | |
High Plains Research Network | Recruiting |
Aurora, Colorado, United States, 80054 | |
Contact: Linda Zittleman, MSPH 303-724-9716 linda.zittleman@ucdenver.edu | |
United States, Florida | |
COPD Foundation | Not yet recruiting |
Miami, Florida, United States, 33134 | |
Contact: Barbara Yawn, MD Byawn@copdfoundation.org | |
United States, Illinois | |
Cook County Hospital | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Min Joo, MD, MPH 312-996-8039 joo@uic.edu | |
Contact: Esther Pacheco 312-413-3438 estherp@uic.edu | |
University of Illinois at Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Min Joo, MD, MPH 312-996-8039 joo@uic.edu | |
Contact: Esther Pacheco 312-413-3438 estherp@uic.edu | |
United States, North Carolina | |
Atrium Healthcare | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Contact: Hazel Tapp, PhD 704-304-7120 Hazel.Tapp@atriumhealth.org | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27701 | |
Contact: Rowena Dolor, MD 919-668-8627 rowena.dolor@duke.edu | |
United States, Oregon | |
Oregon Rural Practice-based Research Network (ORPRN) | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Lyle J Fagnan, MD 503-494-0361 fagnanl@ohsu.edu |
Principal Investigator: | Fernando J Martinez, MD, MS | Weill Cornell Medicine | |
Principal Investigator: | MeiLan Han, MD, MS | University of Michigan |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT03583099 |
Other Study ID Numbers: |
1803019032-3 R01HL136682-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 11, 2018 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |