Clinical trial NCT02627599: A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
Official title: A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
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
Lead sponsor: StratiHealth
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
name: University of Pennsylvania
First posted: 2015-12-11
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease

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.

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
* 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

Primary outcomes:
measure: Baseline Dyspnea Index (BDI)
timeFrame: At baseline once upon entry into the study
measure: Transition Dyspnea Index (TDI)
timeFrame: Every two weeks after baseline up to three months
measure: Chronic Respiratory Disease Questionnaire (CRQ)
timeFrame: At baseline upon study entry and change from baseline every two weeks up to three months
measure: Oxygen Saturation
timeFrame: At baseline upon study entry and change from baseline every two weeks up to three months
measure: Six Minute Walk Distance
timeFrame: At baseline upon study entry and change from baseline every two weeks up to three months
Secondary outcomes:
measure: Portable Oxygen Source Utilization
timeFrame: 6 Months
measure: Healthcare Utilization
timeFrame: 6 Months
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: KP Oceanside Medical Office Building
state: California
city: Vista
country: United States
facility: Tcmc - Mob
state: California
city: Westminster
country: United States
facility: Pathway Medical Group
state: California
Study officials:
affiliation: StratiHealth
name: Isabel Pereira, MD
role: PRINCIPAL_INVESTIGATOR
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