To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
National Jewish Health
Denver, Colorado, United States
University of Illinois, Chicago
Chicago, Illinois, United States
St. Vincent Airways
Indianapolis, Indiana, United States
Physical Activity Level
Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.
Time frame: 12 weeks
St. George Respiratory Questionnaire (SGRQ)
Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 12 weeks
Oxygen Usage
Change in Total Hours of Use
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS): Anxiety
Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.
Time frame: 12 weeks
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University of Iowa
Iowa City, Iowa, United States
Kentucky Research Group
Louisville, Kentucky, United States
ClinSite LLC
Ann Arbor, Michigan, United States
Minnesota Lung Center
Edina, Minnesota, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
Minnesota Lung Center
Woodbury, Minnesota, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
...and 1 more locations