The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)
NCT ID: NCT03583099
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2004 participants
INTERVENTIONAL
2018-10-12
2023-04-07
Brief Summary
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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.
The CAPTURE 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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).
OTHER
DOUBLE
Practitioners in both intervention arms will be blinded to research spirometry results.
Participants will be blinded to spirometry results.
Study Groups
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COPD Education
Practice clinicians will receive basic COPD education only.
COPD Education Only
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.
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.
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.
Interventions
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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.
COPD Education Only
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
National Jewish Health
OTHER
Wake Forest University Health Sciences
OTHER
Duke University
OTHER
High Plains Research Network
NETWORK
L.A. Net Community Health Resource Network
OTHER
Oregon Health and Science University
OTHER
University of Kentucky
OTHER
University of Minnesota
OTHER
COPD Foundation
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Fernando J Martinez, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
MeiLan Han, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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LANet
Los Angeles, California, United States
High Plains Research Network
Aurora, Colorado, United States
COPD Foundation
Miami, Florida, United States
Cook County Hospital
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Circuit Clinical
Buffalo, New York, United States
Atrium Healthcare
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Oregon Rural Practice-based Research Network (ORPRN)
Portland, Oregon, United States
Countries
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References
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Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1803019032-3
Identifier Type: -
Identifier Source: org_study_id
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