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A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
February 1, 2013
Primary Completion Date
January 1, 2015
Completion Date
January 1, 2015
Last Updated
May 11, 2016
346
ACTUAL participants
Lead Sponsor
University of Michigan
Collaborators
NCT07477600
NCT07382258
NCT07195838
Data Source & Attribution
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