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

NCT ID: NCT03581227

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4679 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-12

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants without a diagnosis of COPD

Men and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)

CAPTURE Tool

Intervention Type OTHER

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

Interventions

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CAPTURE Tool

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

High Plains Research Network

NETWORK

Sponsor Role collaborator

L.A. Net Community Health Resource Network

OTHER

Sponsor Role collaborator

COPD Foundation

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando J Martinez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

MeiLan Han

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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LANet

Los Angeles, California, United States

Site Status

High Plains Research Network

Aurora, Colorado, United States

Site Status

COPD Foundation

Miami, Florida, United States

Site Status

Cook County Health

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Atrium Healthcare

Charlotte, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Oregon Rural Practice-based Research Network (ORPRN)

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Martinez FJ, Yawn BP, Angulo D, Lopez C, Murray S, Mannino D, Anderson S, Dolor R, Elder N, Joo M, Khan I, Knox LM, Meldrum C, Peters E, Spino C, Tapp H, Thomashow B, Zittleman L, Brown R, Make B, Han MK; CAPTURE Study Group. Impact of the CAPTURE Chronic Obstructive Pulmonary Disease Screening Tool in U.S. Primary Care: A Cluster-Randomized Trial. Am J Respir Crit Care Med. 2025 May;211(5):789-802. doi: 10.1164/rccm.202405-0921OC.

Reference Type DERIVED
PMID: 39715575 (View on PubMed)

Other Identifiers

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R01HL136682-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1803019032-1

Identifier Type: -

Identifier Source: org_study_id

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