University of Illinois
Chicago, Illinois, 60612, United States
NCT Number: NCT01833026
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out.
For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient associated outcomes compared to usual care which may or may not include the use of spirometry. To do this, we propose a comparative effectiveness trial of introducing a COPD assessment and management bundle targeted to primary care providers for patients suspected of having COPD versus usual care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients, male and female, who are at least 40 years of age, receive primary treatment at the University of Illinois , and with any one of the following:
New Diagnosis
Inpatient or emergency department setting
Outpatient setting
Existing Diagnosis
Exclusion criteria
For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air.
Other names: KoKo Spirometer (Model 313105), 3 Liter Calibration Syringe
The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry.
Other names: Xopenex®: 4 puffs administered 30 seconds apart
Time frame: spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups
accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7.
University of Illinois at Chicago
Other
Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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