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

StratiHealth

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT01948544

01053013A

Details and patient eligibility

About

• 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)

Full 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).

Enrollment: 27 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No 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

Trial design

27 participants in 1 patient group

chronic obstructive pulmonary disease

Description:

* 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: 1. support increased activity 2. improve quality of life 3. increase functional capacity