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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948544
• Other study ID #: 01053013A
• Status: Completed
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2018
• Source: StratiHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Tri-City Pulmonary Medical Group	Oceanside	California
United States	Cardinal Medical Group	Vista	California
United States	Pathway Medical Group	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
StratiHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity	Change in functional capability, dyspnea - BDI/TDI; • Change in exercise capability - 6MWT	6 months
Primary	Quality of Life Using Chronic Respiratory Disease Questionnaire	Quality of life - 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