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

Temple University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00774176

PA DOH RFA-02-07-20

Details and patient eligibility

About

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.

Full description

• 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

Enrollment: 1,066 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation

• Phase 1 & 2: COPD & ONE of the following criteria:

  1. History of hospitalization for COPD exacerbation, OR
  2. Currently on supplemental oxygen, OR
  3. History of evaluation for lung transplant or LVRS, OR
  4. >/= 6 months post-LVRS

• Phase 1 or 2:

  1. Current or former smoker, >/= 20 pack-yr. smoking history
  2. FEV1 </= 70%; FEV1/FVC </= 70%
  3. 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%

Trial design

1,066 participants in 3 patient groups

1

Description:

Phase 1 \& Gene Expression:Hospitalized COPD exacerbators

2

Description:

Phase 2: COPD group

3

Description:

Genetic Association Studies: COPD and Healthy Controls