Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

Study Overview
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Brief Summary
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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.

Official Title
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Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

Conditions
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COPD

Intervention / Treatment
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* Device: Portable Oxygen Concentrator (POC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 40 years or older. Patient has a documented diagnosis of COPD. Patient qualifies for continuous (24/7) long-term oxygen therapy. Patient is prescribed oxygen at ≤ 5 L/min. Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study. Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization. Exclusion Criteria: Patient's condition is contraindicated for the use of a POC. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated. Patient is unable to complete the 6-minute walk test. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids. Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status. Patient has an open skin ulcer or rash where the activity monitor will be worn on the body. Patient has a life expectancy < 1 year. Patient has non-COPD lung disease that may affect oxygenation or survival. Patient has a planned intervention(s) requiring hospitalization within the three months of study participation. Patient is pregnant or planning to become pregnant. Patient is participating in a clinical study of a medical product and has not completed the required follow-up period. Patient, in the opinion of the investigator, should be excluded from the study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Of Care (SOC)<br>Standard of care long-term oxygen therapy | |
| Experimental: SOC + POC (Portable Oxygen Concentrator)<br>Standard of care long-term oxygen therapy + POC | Device: Portable Oxygen Concentrator (POC)<br>* COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Oxygen Usage | Change in Total Hours of Use | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POC, COPD, Oxygen, QoL