Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lancaster General Hospital, Lancaster, Pennsylvania, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

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.

Time frame: Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.

Secondary outcomes

Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

Pennsylvania Department of Health

Registry information

Official study title

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

Acronym: PA-SCOPE

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Oct 17, 2008
Registry last updated: Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Completed