A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- StratiHealth
- Enrollment
- 35
- Locations
- 3
- Primary Endpoint
- Six Minute Walk Distance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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Evaluate subjects in an prospective observational study
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Subjects will be administered scientifically validated questionnaires
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Evaluate Quality Improvement and Oxygen Utilization Improvements.
- Functional capability, dyspnea, oxygen saturation as primary endpoints
- Baseline Dyspnea Index (BDI)
- Transitional Dyspnea Index (TDI)
- Chronic Respiratory Disease Questionnaire (CRQ)
- Six minute walk distance (6MWD)
- Oxygen saturation using pulse oximeter
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The secondary endpoints:
- Portable oxygen source utilization
- Health care utilization (emergency room encounters, hospital admissions)
Detailed Description
Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary diagnosis of chronic obstructive pulmonary disease (COPD)
- •Clinically stable disease at the time of consent
- •Current prescription of oxygen 24 hours a day
- •Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
- •Highest measured FEV1, 70% predicted; and
- •Highest measured FEV1/FVC, 70% predicted
- •Capable of giving informed consent
- •Currently using a portable oxygen source that is a portable tank
- •Mobility without a walker, cane or rollator
- •Spo2 ≥ 90% on portable oxygen source at rest and activity
Exclusion Criteria
- •Cardiovascular disease - New York Heart Association Functional Class III
- •Degenerative bone or joint disease with limited functional ability
- •Current homeless persons
- •Active drug/alcohol dependence
- •Recent drug or alcohol abuse history within the past two years
- •Clinically unstable at the time of consent
- •Currently a tobacco smoker
Outcomes
Primary Outcomes
Six Minute Walk Distance
Time Frame: At baseline upon study entry and change from baseline every two weeks up to three months
Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability
Transition Dyspnea Index (TDI)
Time Frame: Every two weeks after baseline up to three months
Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI)
Oxygen Saturation
Time Frame: At baseline upon study entry and change from baseline every two weeks up to three months
Assess pulse oximetry saturation at baseline on setting to maintain oxygen saturation equal to or greater than 90% at rest and with activity every two weeks to determine improvement or equivalence
Baseline Dyspnea Index (BDI)
Time Frame: At baseline once upon entry into the study
Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)
Chronic Respiratory Disease Questionnaire (CRQ)
Time Frame: At baseline upon study entry and change from baseline every two weeks up to three months
Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire
Secondary Outcomes
- Portable Oxygen Source Utilization(6 Months)
- Healthcare Utilization(6 Months)