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Completed

NCT Number: NCT02627599

A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device

* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Evaluate Quality Improvement and Oxygen Utilization Improvements.

1. Functional capability, dyspnea, oxygen saturation as primary endpoints 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk distance (6MWD) 5. Oxygen saturation using pulse oximeter * The secondary endpoints:

1. Portable oxygen source utilization 2. Health care utilization (emergency room encounters, hospital admissions)

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Key information

Conditions

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

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KP Oceanside Medical Office Building, Oceanside, California, United States

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About this study

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 Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of chronic obstructive pulmonary disease (COPD)
  • Clinically stable disease at the time of consent
  • Current prescription of oxygen 24 hours a day
  • Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
  • Highest measured FEV1, 70% predicted; and
  • Highest measured FEV1/FVC, 70% predicted
  • Capable of giving informed consent
  • Currently using a portable oxygen source that is a portable tank
  • Mobility without a walker, cane or rollator
  • Spo2 ≥ 90% on portable oxygen source at rest and activity
  • Non-smoker at time of consent

Exclusion criteria

  • Cardiovascular disease - New York Heart Association Functional Class III
  • Degenerative bone or joint disease with limited functional ability
  • Current homeless persons
  • Active drug/alcohol dependence
  • Recent drug or alcohol abuse history within the past two years
  • Clinically unstable at the time of consent
  • Currently a tobacco smoker

Treatment and study plan

Breath Responsive Variable Bolus Oxygen Conserving Device

Device

Mini Electronic Oxygen Conserving Device

Other names: SmartDose®

Primary outcomes

  1. Baseline Dyspnea Index (BDI)

    Time frame: At baseline once upon entry into the study

    Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)

  2. Transition Dyspnea Index (TDI)

    Time frame: Every two weeks after baseline up to three months

    Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI)

  3. Chronic Respiratory Disease Questionnaire (CRQ)

    Time frame: At baseline upon study entry and change from baseline every two weeks up to three months

    Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire

  4. Oxygen Saturation

    Time frame: At baseline upon study entry and change from baseline every two weeks up to three months

    Assess pulse oximetry saturation at baseline on setting to maintain oxygen saturation equal to or greater than 90% at rest and with activity every two weeks to determine improvement or equivalence

  5. Six Minute Walk Distance

    Time frame: At baseline upon study entry and change from baseline every two weeks up to three months

    Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability

Secondary outcomes

  1. Portable Oxygen Source Utilization

    Time frame: 6 Months

    Reduction in Portable Oxygen Source Use from baseline on enrollment with assessments of use each day throughout study period to determine if there are utilization reductions resulting in cost savings during study period.

  2. Healthcare Utilization

    Time frame: 6 Months

    Unscheduled Hospital, Emergency Room or Physician Office Visits, as measured from baseline 6 months prior to study entry and during study period to identify utilization changes if any.

Sponsors and collaborators

Lead sponsor

StratiHealth

Industry

Collaborators

  • Kaiser Permanente
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: BRVB-OCD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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