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

NCT01948544 | Completed DMC

• 1 other identifier: 01053013A
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 3

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)

Conditions

COPD

Keywords

COPD; LTOT; Long-Term Oxygen Therapy; Portable Oxygen Concentrator; Quality of Life; Six Minute Walk Distance Test

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• StratiHealth: lead

Study Sites (3)

Tri-City Pulmonary Medical Group

Oceanside, California, 92054, United States

Location

Cardinal Medical Group

Vista, California, 92083, United States

Location

Pathway Medical Group

Westminster, California, 92683, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabel Pereira, MD

  Tri-City Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

US (3)