Developing a COPD Case Finding Methodology for Primary Care
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| ClinicalTrials.gov Identifier: NCT01880177 |
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Recruitment Status :
Completed
First Posted : June 18, 2013
Last Update Posted : May 11, 2016
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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 |
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| Chronic Obstructive Pulmonary Disease (COPD) |
| 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 |
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Current smokers
Current smokers (>10 pk yrs.)
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Ex-smokers
Ex-smokers with a history of >10 pk yrs
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Never-smokers
Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life
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- COPD Case Finding Tool [ Time Frame: 24 months ]
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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 |
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
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
| 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 | |
| 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):
| 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 |
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Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |