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

NCT01044927 | Completed Phase 3

• 2 other identifiers: 06-058707 FLA 00834
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; telemedicine; COPD

Outcome Measures

Primary Outcomes (1)

• Healthcare utilization

  9 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Proactive Integrated Care

EXPERIMENTAL

COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator

Other: Integrated Care

Standard Care Control

ACTIVE COMPARATOR

No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.

Other: Standard Therapy

Interventions

Integrated Care OTHER

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)

Proactive Integrated Care

Standard Therapy OTHER

No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.

Standard Care Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Department of Public Health and Environment: collaborator
• Kaiser Permanente: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Kaiser Permanente

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Delivery of Health Care, Integrated; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Quality of Health Care

Study Officials

• William Vandivier, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: September 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: June 1, 2008
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

US (2)