Developing a COPD Case Finding Methodology for Primary Care

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880177
• Other study ID #: HUM00068783
• Secondary ID: 7R01HL114055-03
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: May 10, 2016
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Kentucky	Lexington	Kentucky
United States	Columbia University Medical center / New York Presbyterian Hospital	New York	New York
United States	UNMC College of Medicine	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI), United BioSource Corporation

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Hanania NA, Mannino DM, Yawn BP, Mapel DW, Martinez FJ, Donohue JF, Kosinski M, Rendas-Baum R, Mintz M, Samuels S, Jhingran P, Dalal AA. Predicting risk of airflow obstruction in primary care: Validation of the lung function questionnaire (LFQ). Respir Med. 2010 Aug;104(8):1160-70. doi: 10.1016/j.rmed.2010.02.009. Epub 2010 Mar 11. — View Citation

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Sichletidis L, Spyratos D, Papaioannou M, Chloros D, Tsiotsios A, Tsagaraki V, Haidich AB. A combination of the IPAG questionnaire and PiKo-6® flow meter is a valuable screening tool for COPD in the primary care setting. Prim Care Respir J. 2011 Jun;20(2):184-9, 1 p following 189. doi: 10.4104/pcrj.2011.00038. — View Citation

Tinkelman DG, Price DB, Nordyke RJ, Halbert RJ, Isonaka S, Nonikov D, Juniper EF, Freeman D, Hausen T, Levy ML, Ostrem A, van der Molen T, van Schayck CP. Symptom-based questionnaire for differentiating COPD and asthma. Respiration. 2006;73(3):296-305. Epub 2005 Dec 5. — View Citation

Van Schayck CP, Loozen JM, Wagena E, Akkermans RP, Wesseling GJ. Detecting patients at a high risk of developing chronic obstructive pulmonary disease in general practice: cross sectional case finding study. BMJ. 2002 Jun 8;324(7350):1370. — View Citation

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Yawn BP, Mapel DW, Mannino DM, Martinez FJ, Donohue JF, Hanania NA, Kosinski M, Rendas-Baum R, Mintz M, Samuels S, Dalal AA; Lung Function Questionnaire Working Group. Development of the Lung Function Questionnaire (LFQ) to identify airflow obstruction. Int J Chron Obstruct Pulmon Dis. 2010 Feb 18;5:1-10. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD Case Finding Tool		24 months	No