Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 6, 2010
October 3, 2012
September 2006
August 2007   (final data collection date for primary outcome measure)
Healthcare utilization [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044927 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado
Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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)
  • Other: Standard Therapy
    No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.
  • Experimental: Proactive Integrated Care
    COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator
    Intervention: Other: Integrated Care
  • Active Comparator: Standard Care Control
    No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.
    Intervention: Other: Standard Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
June 2008
August 2007   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01044927
06-0587, 07 FLA 00834
No
University of Colorado, Denver
University of Colorado, Denver
  • Colorado Department of Public Health and Environment
  • Kaiser Permanente
  • Department of Veterans Affairs
Principal Investigator: William Vandivier, MD University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP