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

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

• 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)

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92054
      • Tri-City Pulmonary Medical Group
    • Vista, California, United States, 92083
      • Cardinal Medical Group
    • Westminster, California, United States, 92683
      • Pathway Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COPD Patients prescreened and selected by their primary care physician or pulmonologist

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 activityimprove quality of lifeincrease functional capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Change in functional capability, dyspnea - BDI/TDI • Change in exercise capability - 6MWT	6 months
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

Collaborators and Investigators

• Sponsor: StratiHealth
• Investigators: Principal Investigator: Isabel Pereira, MD, Tri-City Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (ESTIMATE): September 23, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; COPD; LTOT; Long-Term Oxygen Therapy; Portable Oxygen Concentrator; Six Minute Walk Distance Test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 01053013A