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

* 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)

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tri-City Pulmonary Medical Group, Oceanside, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Functional Capacity

Time frame: 6 months
Change in functional capability, dyspnea - BDI/TDI
- Change in exercise capability - 6MWT
Quality of Life Using Chronic Respiratory Disease Questionnaire

Time frame: 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

Sponsors and collaborators

Lead sponsor

StratiHealth

Industry

Registry information

Official study title

A Study to Evaluate Improvement in the Quality of Life and Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Sep 23, 2013
Registry last updated: Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed