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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Integrated Care; Other: Standard Therapy

• Registration Number: NCT01044927
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-08
• Study Completion: 2008-06
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Healthcare utilization	9 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life by St. Georges Respiratory Questionnaire	3, 6 and 9 months
Guideline-based medical therapy	9 months
Exercise capacity	9 months
Oxygen utilization and pre-and post-exercise oxygen saturations	9 months
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index	9 months
Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)	9 months
Smoking status	9 months
Pulmonary rehabilitation	9 months

Trial Locations

Locations (2)

Kaiser Permanente; 🇺🇸 Denver, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States