Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

Completed

• Conditions: COPD

• Registration Number: NCT01948544
• Lead Sponsor: StratiHealth

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).

Study Timeline

• Study First Submitted: 2013-07-19
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-23
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Capacity	6 months	Change in functional capability, dyspnea - BDI/TDI; • Change in exercise capability - 6MWT
Quality of Life Using Chronic Respiratory Disease Questionnaire	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	Quality of life - Chronic Respiratory Disease Questionnaire

Trial Locations

Locations (3)

Cardinal Medical Group; 🇺🇸 Vista, California, United States

Tri-City Pulmonary Medical Group; 🇺🇸 Oceanside, California, United States

Pathway Medical Group; 🇺🇸 Westminster, California, United States