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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044927
• Other study ID #: 06-0587
• Secondary ID: 07 FLA 00834
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2010
• Last updated: October 3, 2012
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: June 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Integrated Care
Comparison of the effect of COPD education, self-management instruction, home monitoring with a Health Buddy Telemonitor, pulse oximeter, pedometer and spirometer, and enhanced communication with a study coordinator (cell phone access)
• Standard Therapy
No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Kaiser Permanente	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Department of Public Health and Environment, Kaiser Permanente, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare utilization		9 months	No
Secondary	Quality of Life by St. Georges Respiratory Questionnaire		3, 6 and 9 months	No
Secondary	Guideline-based medical therapy		9 months	No
Secondary	Exercise capacity		9 months	No
Secondary	Oxygen utilization and pre-and post-exercise oxygen saturations		9 months	No
Secondary	Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index		9 months	No
Secondary	Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)		9 months	No
Secondary	Smoking status		9 months	No
Secondary	Pulmonary rehabilitation		9 months	No

External Links

•   Program description