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Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Completed
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Other: Standard Therapy
Other: Integrated Care

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01044927
07 FLA 00834 (Other Identifier)
06-0587

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs. Based upon these national COPD prevalence data, we estimate that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the care of these patients costs up to $490 million annually. Therefore, to alter the impact of COPD on the State and People of Colorado, we propose to introduce a telephone-dependent, internet-supported, self-monitoring "eHealth" management system in both urban and rural Colorado settings in order to decrease healthcare utilization, improve the management of COPD based upon current national guidelines, improve quality of life, reduce health care costs decrease COPD exacerbations. We base this program on a successful clinical pilot study, performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated dramatic improvements in quality of life and decreased health care costs. We propose to enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the patients with the highest healthcare costs, the greatest disability, and the highest mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy of this proactive management strategy as it is disseminated throughout urban and rural Colorado. In this first phase we will target two Denver Metro sites, UCH and Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites because of their strong interest in enacting the eHealth Program, because of their organized systems of healthcare delivery and because of the numbers of COPD patients that they serve. We are particularly enthusiastic about the application of this technology to rural, underserved areas, because this approach has the potential to dramatically improve delivery of healthcare to a large portion of Colorado that is chronically plagued by inadequate health care networks and lack of specialty care. More broadly, we are enthusiastic about the prospect that eHealth programs may hold the potential to improve healthcare delivery for many chronic illnesses, in addition to COPD.

Enrollment

511 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • COPD Diagnosis per GOLD Guidelines
  • Airflow obstruction on spirometry defined as an FEV1/FVC less than or equal to 70% and an FEV1 less than or equal to 50% predicted, or an FEV1 greater than 50% predicted with a history of a COPD exacerbation within the previous year.
  • Standard telephone access
  • US Citizen and Colorado resident

Exclusion criteria

  • Asthma
  • Co-existing conditions that are likely to cause death within two years, CXR evidence of interstitial lung disease or other pulmonary diagnoses at the time of enrollment, end-stage liver disease, end-stage renal disease, end-stage muscle disease, HIV disease or dementia.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

511 participants in 2 patient groups

Proactive Integrated Care
Experimental group
Description:
COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator
Treatment:
Other: Integrated Care
Standard Care Control
Active Comparator group
Description:
No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.
Treatment:
Other: Standard Therapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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