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 Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2020-09-02

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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Of Care (SOC)

Standard of care long-term oxygen therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

SOC + POC (Portable Oxygen Concentrator)

Standard of care long-term oxygen therapy + POC

Group Type EXPERIMENTAL

Portable Oxygen Concentrator (POC)

Intervention Type DEVICE

COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)

Interventions

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Portable Oxygen Concentrator (POC)

COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is 40 years or older.
2. Patient has a documented diagnosis of COPD.
3. Patient qualifies for continuous (24/7) long-term oxygen therapy.
4. Patient is prescribed oxygen at ≤ 5 L/min.
5. Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.
6. Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.
7. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.

Exclusion Criteria

1. Patient's condition is contraindicated for the use of a POC.
2. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
3. Patient is unable to complete the 6-minute walk test.
4. 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.
5. Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
6. Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
7. Patient has a life expectancy \< 1 year.
8. Patient has non-COPD lung disease that may affect oxygenation or survival.
9. Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
10. Patient is pregnant or planning to become pregnant.
11. Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
12. Patient, in the opinion of the investigator, should be excluded from the study.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No