Developing a COPD Case Finding Methodology for Primary Care

NCT ID: NCT01880177

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-01-31

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)

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Current smokers

Current smokers (\>10 pk yrs.)

No interventions assigned to this group

Ex-smokers

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

No interventions assigned to this group

Never-smokers

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United BioSource, LLC

INDUSTRY

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Fernando J. Martinez, MD, MS

Professor, Department of Internal Medicine at University of Michigan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando J Martinez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Nancy K Leidy, PhD

Role: PRINCIPAL_INVESTIGATOR

United BioSource, LLC

David Mannino, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

UNMC College of Medicine

Omaha, Nebraska, United States

Columbia University Medical center / New York Presbyterian Hospital

New York, New York, United States

Countries

United States

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Other Identifiers

7R01HL114055-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00068783

Identifier Type: -

Identifier Source: org_study_id