Clinical trial NCT01948544: Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease
Official title: A Study to Evaluate Improvement in the Quality of Life and 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
Portable Oxygen Concentrator
Quality of Life
Six Minute Walk Distance Test
Lead sponsor: StratiHealth
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD Patients prescreened and selected by their primary care physician or pulmonologist

Brief summary: * Evaluate subjects in an prospective observational study
* Subjects will be administered scientifically validated questionnaires
* Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:

  1. Exercise capability, dyspnea and quality of life as primary endpoints
  2. Utilize:

     1. Baseline Dyspnea Index (BDI)
     2. Transitional Dyspnea Index (TDI)
     3. Chronic Respiratory Disease Questionnaire (CRQ)
     4. Six minute walk test (6MWT)
     5. Epworth Sleepiness Scale (ESS)
* The secondary endpoints will be:

  1. Rate of exacerbations, sleep quality
  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 the affect of the Portable Oxygen Concentrator on improvements in exercise capability, dyspnea and quality of life as primary endpoints, utilizing the Baseline Dyspnea Index (BDI), Transitional Dyspnea Index (TDI), the Chronic Respiratory Disease Questionnaire (CRQ) and six minute walk test (6MWT). The secondary endpoints will be rate of exacerbations, sleep quality (reported as number of hours sleep improvement; utilize Epworth Sleepiness Scale \[ESS\]), and health care utilization (emergency room encounters, hospital admissions).

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of chronic obstructive pulmonary disease (COPD)
* Clinically stable disease at the time of consent
* Current prescription of oxygen; with previous or current oximetry suggesting desaturation at rest or during exercises (oxygen saturation ≤88% on at least one occasion)
* Highest measured FEV1, 70% predicted; and
* Highest measured FEV1/FVC, 70% predicted
* Capable of giving informed consent
* Currently using oxygen system that is either a portable tank; liquid or other Portable Oxygen Concentrator (POC)
* Mobility without a walker, cane or rollator
* Spo2 ≥ 92% on Portable Oxygen Concentrator (POC) at rest and activity
* Non-smoker at time of consent

Exclusion Criteria:

* Cardiovascular disease as defined in New York Heart Association Functional Class III
* Degenerative bone or joint disease that limits mobility and ability to perform activities of daily living and/or exercise
* Current homeless persons
* Active drug/alcohol dependence
* Recent abuse history within the past two years
* Clinically unstable at the time of consent
* Currently a tobacco smoker

Primary outcomes:
measure: Functional Capacity
timeFrame: 6 months
measure: Quality of Life Using Chronic Respiratory Disease Questionnaire
timeFrame: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Tri-City Pulmonary Medical Group
state: California
city: Vista
country: United States
facility: Cardinal Medical Group
state: California
city: Westminster
country: United States
facility: Pathway Medical Group
state: California
Study officials:
affiliation: Tri-City Medical Center
name: Isabel Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: