Developing a COPD Case Finding Methodology for Primary Care

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01880177
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• 1. Age ≥40 years
• 2. 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
• 3. Stable state PFT values from within the last 12 months available or obtainable
• 4. Willing and able to attend the focus group session or cognitive interview
• 5. Able to read and speak in English
• 6. Willing and able to provide written Informed Consent

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD Case Finding Tool	24 months

Trial Locations

Locations (4)

UNMC College of Medicine; 🇺🇸 Omaha, Nebraska, United States

Columbia University Medical center / New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States