Clinical trial NCT03581227: The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 1)
Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: CAPTURE, COPD
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Michigan
name: National Jewish Health
name: University of Minnesota
name: Duke University
name: Wake Forest University Health Sciences
name: Oregon Health and Science University
name: High Plains Research Network
name: L.A. Net Community Health Resource Network
name: COPD Foundation
name: University of Kentucky
First posted: 2018-07-10
Enrollment: 4679
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult men and women recruited from a broad range of primary care settings across the United States.

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.

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: Positive and negative predictive values (PPV and NPV) in different practice settings
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
timeFrame: Baseline
measure: Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at baseline
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD
timeFrame: Baseline
measure: Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline
timeFrame: Baseline
measure: Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD
timeFrame: Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LANet
state: California
city: Aurora
country: United States
facility: High Plains Research Network
state: Colorado
city: Miami
country: United States
facility: COPD Foundation
state: Florida
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Charlotte
country: United States
facility: Atrium Healthcare
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Rural Practice-based Research Network (ORPRN)
state: Oregon
Study officials:
affiliation: Weill Medical College of Cornell University
name: Fernando J Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: MeiLan Han
role: PRINCIPAL_INVESTIGATOR
References: