COPD
Conditions
Keywords
COPD, LTOT, Long-Term Oxygen Therapy, Oxygen Conserving Device, Quality of Life, Six Minute Walk Distance, Portable Oxygen Source, Oxygen Saturation, Breath Responsive Variable Bolus Oxygen Conserving Device, BRVB-OCD, Pulse Oximetry
Brief summary
* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Evaluate Quality Improvement and Oxygen Utilization Improvements. 1\. Functional capability, dyspnea, oxygen saturation as primary endpoints 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk distance (6MWD) 5. Oxygen saturation using pulse oximeter * The secondary endpoints: 1. Portable oxygen source utilization 2. 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.
Interventions
DEVICEBreath Responsive Variable Bolus Oxygen Conserving Device
Mini Electronic Oxygen Conserving Device
Sponsors
Kaiser Permanente
University of Pennsylvania
StratiHealth
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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 * Non-smoker at time of consent
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Dyspnea Index (TDI) | Every two weeks after baseline up to three months | Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI) |
| Oxygen Saturation | 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 |
| Six Minute Walk Distance | 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 |
| Baseline Dyspnea Index (BDI) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | 6 Months | Unscheduled Hospital, Emergency Room or Physician Office Visits, as measured from baseline 6 months prior to study entry and during study period to identify utilization changes if any. |
| Portable Oxygen Source Utilization | 6 Months | Reduction in Portable Oxygen Source Use from baseline on enrollment with assessments of use each day throughout study period to determine if there are utilization reductions resulting in cost savings during study period. |
Countries
United States
Outcome results
None listed