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Trial record 48 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT03581227
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
University of Minnesota - Clinical and Translational Science Institute
Duke University
Atrium Health
Oregon Health and Science University
High Plains Research Network
L.A. Net Community Health Resource Network
COPD Foundation
University of Kentucky
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
A prospective multi-center study to define the sensitivity and specificity of CAPTURE for identifying previously undiagnosed patients with clinically significant COPD in a broad range of primary care settings.

Condition or disease Intervention/treatment
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.


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Study Type : Observational
Estimated Enrollment : 5000 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 : September 17, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort 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




Primary Outcome Measures :
  1. Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult men and women recruited from a broad range of primary care settings across the United States.
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 45-80 years

Exclusion Criteria:

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

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

Information from the National Library of Medicine

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): NCT03581227


Contacts
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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

Locations
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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, 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   
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 - Clinical and Translational Science Institute
Duke University
Atrium Health
Oregon Health and Science University
High Plains Research Network
L.A. Net Community Health Resource Network
COPD Foundation
University of Kentucky
Investigators
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Principal Investigator: Fernando J Martinez, MD, MS Weill Cornell Medicine
Principal Investigator: MeiLan Han University of Michigan

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03581227     History of Changes
Other Study ID Numbers: 1803019032-1
R01HL136682-01 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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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:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases