Clinical trial NCT01044927: Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado
Official title: Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
telemedicine
COPD
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Department of Public Health and Environment
name: Kaiser Permanente
name: US Department of Veterans Affairs
First posted: 2010-01-08
Enrollment: 511
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Healthcare utilization
timeFrame: 9 months
Secondary outcomes:
measure: Quality of Life by St. Georges Respiratory Questionnaire
timeFrame: 3, 6 and 9 months
measure: Guideline-based medical therapy
timeFrame: 9 months
measure: Exercise capacity
timeFrame: 9 months
measure: Oxygen utilization and pre-and post-exercise oxygen saturations
timeFrame: 9 months
measure: Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index
timeFrame: 9 months
measure: Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)
timeFrame: 9 months
measure: Smoking status
timeFrame: 9 months
measure: Pulmonary rehabilitation
timeFrame: 9 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: William Vandivier, MD
role: PRINCIPAL_INVESTIGATOR
References: