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Developing a COPD Case Finding Methodology for Primary Care

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ClinicalTrials.gov Identifier: NCT01880177
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
United BioSource Corporation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Fernando J. Martinez, MD, MS, 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.


Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

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Study Type : Observational
Actual Enrollment : 346 participants
Time Perspective: Cross-Sectional
Official Title: A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases
Study Start Date : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Group/Cohort
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



Primary Outcome Measures :
  1. COPD Case Finding Tool [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880177


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
UNMC College of Medicine
Omaha, Nebraska, United States, 68198
United States, New York
Columbia University Medical center / New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
University of Michigan
United BioSource Corporation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Fernando J Martinez, MD, MS University of Michigan
Principal Investigator: Nancy K Leidy, PhD United BioSource Corporation
Principal Investigator: David Mannino, MD University of Kentucky

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando J. Martinez, MD, MS, Professor, Department of Internal Medicine at University of Michigan, University of Michigan
ClinicalTrials.gov Identifier: NCT01880177     History of Changes
Other Study ID Numbers: HUM00068783
7R01HL114055-03 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases