Developing a COPD Case Finding Methodology for Primary Care

University of Michigan

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01880177

7R01HL114055-03 (U.S. NIH Grant/Contract)

HUM00068783

Details and patient eligibility

About

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.

Enrollment: 346 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

346 participants in 3 patient groups

Current smokers

Description:

Current smokers (\>10 pk yrs.)

Ex-smokers

Description:

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

Never-smokers

Description:

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