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

Sponsor

StratiHealth (Industry)

Overall Status

Completed

CT.gov ID

NCT01948544

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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:

Exercise capability, dyspnea and quality of life as primary endpoints
Utilize:
Baseline Dyspnea Index (BDI)
Transitional Dyspnea Index (TDI)
Chronic Respiratory Disease Questionnaire (CRQ)
Six minute walk test (6MWT)
Epworth Sleepiness Scale (ESS)

The secondary endpoints will be:

Rate of exacerbations, sleep quality
Health care utilization (emergency room encounters, hospital admissions)

Condition or Disease	Intervention/Treatment	Phase
COPD

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 Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
chronic obstructive pulmonary disease More than 12 million adults are diagnosed with COPD COPD is the 4th leading cause of death in the U.S. Breathing difficulty is the major reason patients seek medical attention COPD patients requiring hospitalization were associated with higher costs Oximetry is an important tool for assessing need for Long-term oxygen therapy LTOT has been proven to improve survival and quality of life Patients will be provided a lightweight portable oxygen concentrator to: support increased activity improve quality of life increase functional capacity

Arm

Intervention/Treatment

chronic obstructive pulmonary disease

More than 12 million adults are diagnosed with COPD COPD is the 4th leading cause of death in the U.S. Breathing difficulty is the major reason patients seek medical attention COPD patients requiring hospitalization were associated with higher costs Oximetry is an important tool for assessing need for Long-term oxygen therapy LTOT has been proven to improve survival and quality of life Patients will be provided a lightweight portable oxygen concentrator to: support increased activity improve quality of life increase functional capacity

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-City Pulmonary Medical Group	Oceanside	California	United States	92054
2	Cardinal Medical Group	Vista	California	United States	92083
3	Pathway Medical Group	Westminster	California	United States	92683