Integrated Care Program for Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01045213|
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : October 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Integrated Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2009|
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.
- Quality of Life measured by the St. Georges Respiratory Questionnaire [ Time Frame: 3 months ]
- Guideline-based medical care [ Time Frame: 3 months ]
- Oxygen utilization and pre/post exercise oxygen saturations [ Time Frame: 3 months ]
- Smoking status [ Time Frame: 3 months ]
- Exercise status measured by the 6 minute walk test [ Time Frame: 3 months ]
- Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale) [ Time Frame: 3 months ]
- Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index [ Time Frame: 3 months ]
- Healthcare utilization [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045213
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||William Vandivier, MD||University of Colorado, Denver|