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Developing a COPD Case Finding Methodology for Primary Care

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01880177
Collaborator
United BioSource, LLC (Industry), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
346
Enrollment
4
Locations
23
Duration (Months)
86.5
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Feb 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2015
    Actual Study Completion Date :
    Jan 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. COPD Case Finding Tool [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. Age ≥40 years
      1. 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
      1. Stable state PFT values from within the last 12 months available or obtainable
      1. Willing and able to attend the focus group session or cognitive interview
      1. Able to read and speak in English
      1. 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
      1. Patient was hospitalized for respiratory infection within the past 30 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40536
    2 University of Michigan Health System Ann Arbor Michigan United States 48109
    3 UNMC College of Medicine Omaha Nebraska United States 68198
    4 Columbia University Medical center / New York Presbyterian Hospital New York New York United States 10032

    Sponsors and Collaborators

    • University of Michigan
    • United BioSource, LLC
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Fernando J Martinez, MD, MS, University of Michigan
    • Principal Investigator: Nancy K Leidy, PhD, United BioSource, LLC
    • Principal Investigator: David Mannino, MD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fernando J. Martinez, MD, MS, Professor, Department of Internal Medicine at University of Michigan, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01880177
    Other Study ID Numbers:
    • HUM00068783
    • 7R01HL114055-03
    First Posted:
    Jun 18, 2013
    Last Update Posted:
    May 11, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of May 11, 2016