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

This study has been completed.
Sponsor:
Collaborators:
Colorado Department of Public Health and Environment
Kaiser Permanente
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01044927
First received: January 6, 2010
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Other: Integrated Care
Other: Standard Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Healthcare utilization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life by St. Georges Respiratory Questionnaire [ Time Frame: 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • Guideline-based medical therapy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Exercise capacity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Oxygen utilization and pre-and post-exercise oxygen saturations [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Smoking status [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Pulmonary rehabilitation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 511
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proactive Integrated Care
COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator
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)
Active Comparator: Standard Care Control
No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.
Other: Standard Therapy
No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044927

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Kaiser Permanente
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Colorado Department of Public Health and Environment
Kaiser Permanente
Investigators
Principal Investigator: William Vandivier, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01044927     History of Changes
Other Study ID Numbers: 06-0587, 07 FLA 00834
Study First Received: January 6, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Chronic obstructive pulmonary disease
telemedicine
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014