Integrated Care Program for Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Integrated Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, COPD
Eligibility Criteria
Inclusion Criteria:
- COPD Diagnosis by Gold Guidelines
- Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
- Standard land-line telephone
- Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado
Exclusion Criteria:
- Asthma
- Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
- Participation in another treatment study
- Inability or unwillingness to cooperate with self-monitoring and reporting components
- Prisoners, pregnant women, institutionalized patients
- Current alcohol or drug abuse
- Non-English speakers
- Inability to complete a consent
- Illegal alien, non-Colorado resident, or non-resident of targeted counties
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proactive Integrated Care
Arm Description
COPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator.
Outcomes
Primary Outcome Measures
Quality of Life measured by the St. Georges Respiratory Questionnaire
Secondary Outcome Measures
Guideline-based medical care
Oxygen utilization and pre/post exercise oxygen saturations
Smoking status
Exercise status measured by the 6 minute walk test
Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index
Healthcare utilization
Full Information
NCT ID
NCT01045213
First Posted
January 6, 2010
Last Updated
October 3, 2012
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01045213
Brief Title
Integrated Care Program for Chronic Obstructive Pulmonary Disease
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proactive Integrated Care
Arm Type
Experimental
Arm Description
COPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator.
Intervention Type
Other
Intervention Name(s)
Integrated Care
Intervention Description
Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.
Primary Outcome Measure Information:
Title
Quality of Life measured by the St. Georges Respiratory Questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Guideline-based medical care
Time Frame
3 months
Title
Oxygen utilization and pre/post exercise oxygen saturations
Time Frame
3 months
Title
Smoking status
Time Frame
3 months
Title
Exercise status measured by the 6 minute walk test
Time Frame
3 months
Title
Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)
Time Frame
3 months
Title
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index
Time Frame
3 months
Title
Healthcare utilization
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD Diagnosis by Gold Guidelines
Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
Standard land-line telephone
Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado
Exclusion Criteria:
Asthma
Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
Participation in another treatment study
Inability or unwillingness to cooperate with self-monitoring and reporting components
Prisoners, pregnant women, institutionalized patients
Current alcohol or drug abuse
Non-English speakers
Inability to complete a consent
Illegal alien, non-Colorado resident, or non-resident of targeted counties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Vandivier, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
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Integrated Care Program for Chronic Obstructive Pulmonary Disease
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