Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations

Study Overview
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Brief Summary
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The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.

Detailed Description
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Overall objective: To determine why African American and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for COPD-and to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention--access to a 1-800 Temple Call Center phone number where patients can get immediate customized advice on managing COPD exacerbations in their early stages. Phase 1: To compare and contrast the influence of race and geographic location in COPD exacerbation in relation to severity, comorbidities, treatment patterns, infection rate. To identify potential risk factors for COPD exacerbations leading to hospitalization. Phase 2: To reduce hospitalizations and deaths due to COPD exacerbations and to improve patient quality of life, lung function, and everyday activity levels

Official Title
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Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation Phase 1 & 2: COPD & ONE of the following criteria: History of hospitalization for COPD exacerbation, OR Currently on supplemental oxygen, OR History of evaluation for lung transplant or LVRS, OR >/= 6 months post-LVRS Phase 1 or 2: Current or former smoker, >/= 20 pack-yr. smoking history FEV1 </= 70%; FEV1/FVC </= 70% Life expectancy of > 6 months Exclusion Criteria: < 20 pack-yr. smoking history Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass Asthma FEV1 > 70% or FEV1/FVC >70%

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Phase 1 & Gene Expression:Hospitalized COPD exacerbators | |
| 2<br>Phase 2: COPD group | |
| 3<br>Genetic Association Studies: COPD and Healthy Controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 identifies the demographic & genetic factors affecting inpatient hospitalization for COPD exacerbation.Phase 2 documents the number of physician & ER visits, hospitalizations & death related to exacerbations. |  | Phase 1 is up to 10 weeks. Phase 2 is up to 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD, COPD Exacerbation, Genetic markers COPD, Gene expression in COPD exacerbations, COPD Exacerbation Symptom Reporting, COPD Exacerbation Disease Management, COPD Treatment, Breathing disorders, Emphysema, COPD with Healthy Control comparators for genetic association studies.