Developing a COPD Case Finding Methodology for Primary Care

NCT01880177 | Completed DMC

• 2 other identifiers: HUM000687837R01HL114055-03
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. This work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. Specific objectives are as follows: Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings. Objective 2: To review the new questionnaire with a new set of participants with a recent COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. This will be done through one-on-one cognitive interviews. Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of COPD and the consistency of readings between electronic and mechanical readings in these patients. This information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• COPD Case Finding Tool

  24 months

Study Arms (3)

Current smokers

Current smokers (\>10 pk yrs.)

Ex-smokers

Ex-smokers with a history of \>10 pk yrs

Never-smokers

Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited through multiple clinic settings, i.e., pulmonology clinics, internal medicine clinics, and primary care/family medicine clinics.

You may qualify if:

• \. Age ≥40 years
• \. Current smokers (\>10 pk yrs.) or Ex-smokers with a history of \>10 pk yrs. or Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life
• \. Stable state PFT values from within the last 12 months available or obtainable
• \. Willing and able to attend the focus group session or cognitive interview
• \. Able to read and speak in English
• \. Willing and able to provide written Informed Consent

You may not qualify if:

• \. Cognitive impairment, hearing or sight difficulty, or severe psychopathology that could interfere with ability to participate in the study
• \. Patient was hospitalized for respiratory infection within the past 30 days

Sponsors & Collaborators

• University of Michigan: lead
• United BioSource, LLC: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

UNMC College of Medicine

Omaha, Nebraska, 68198, United States

Location

Columbia University Medical center / New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (31)

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• Leidy NK, Martinez FJ, Malley KG, Mannino DM, Han MK, Bacci ED, Brown RW, Houfek JF, Labaki WW, Make BJ, Meldrum CA, Quezada W, Rennard S, Thomashow B, Yawn BP. Can CAPTURE be used to identify undiagnosed patients with mild-to-moderate COPD likely to benefit from treatment? Int J Chron Obstruct Pulmon Dis. 2018 Jun 13;13:1901-1912. doi: 10.2147/COPD.S152226. eCollection 2018.

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• Quezada WA, Whippo BA, Jellen PA, Leidy NK, Mannino DM, Kim KJ, Han MK, Houfek JF, Make B, Malley KG, Meldrum CA, Rennard SI, Yawn BP, Martinez FJ, Thomashow BM; High-Risk-COPD Screening Study Group( *). How Well Does CAPTURE Translate?: An Exploratory Analysis of a COPD Case-Finding Method for Spanish-Speaking Patients. Chest. 2017 Oct;152(4):761-770. doi: 10.1016/j.chest.2017.03.047. Epub 2017 Apr 14.

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• Martinez FJ, Mannino D, Leidy NK, Malley KG, Bacci ED, Barr RG, Bowler RP, Han MK, Houfek JF, Make B, Meldrum CA, Rennard S, Thomashow B, Walsh J, Yawn BP; High-Risk-COPD Screening Study Group *. A New Approach for Identifying Patients with Undiagnosed Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Mar 15;195(6):748-756. doi: 10.1164/rccm.201603-0622OC.

  PMID: 27783539 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando J Martinez, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Nancy K Leidy, PhD

  United BioSource, LLC

  PRINCIPAL INVESTIGATOR

• David Mannino, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine at University of Michigan

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 18, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

US (4)