Integrated Care Program for Chronic Obstructive Pulmonary Disease
Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated therapy. Patients enrolled in the program receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function (spirometer) and activity (pedometer). Through the Health Buddy® patients receive guideline-based disease education in their own homes. The Health Buddy® also allows patients to transmit daily information about their symptoms, oxygen levels, lung function and ability to walk to program coordinators located at the University of Colorado Hospital. Our program coordinators are highly experienced nurses or respiratory therapists with expertise in the management of chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Through this remote disease education/monitoring program, patients learn to take a more active role in the management of their own disease. However, once the coordinators identify early warning signs of a potential problem, patients are contacted and connected to their primary healthcare provider for early intervention. By this integrated approach to care, patients learn self-management techniques, physician communication is enhanced, and early interventions for problems are possible. We propose to target the Integrated eHealth Program to areas of Colorado that are highly impacted by COPD.
Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with high COPD mortality rates.
Target Population: We will target patients with severe or very severe COPD.
Expected Outcomes: We expect that this study will increase the use of evidence-based guidelines in the screening, diagnosis and treatment of COPD, resulting in improved quality-of-life and a reduction in healthcare utilization.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality|
- Quality of Life measured by the St. Georges Respiratory Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Guideline-based medical care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Oxygen utilization and pre/post exercise oxygen saturations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Smoking status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Exercise status measured by the 6 minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Healthcare utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Proactive Integrated Care
COPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator.
Other: Integrated Care
Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045213
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||William Vandivier, MD||University of Colorado, Denver|