A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device (BRVB-OCD)

August 13, 2018 updated by: StratiHealth

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

  • 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oceanside, California, United States, 92054
        • KP Oceanside Medical Office Building
      • Vista, California, United States, 92054
        • Tcmc - Mob
      • Westminster, California, United States, 92683
        • Pathway Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Obstructive Pulmonary Disease
  • More than 12 million adults are diagnosed with COPD
  • COPD is the 3rd leading cause of death in the U.S.
  • Breathing difficulty is the major reason patients seek medical attention
  • COPD patients requiring hospitalization are 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 provided with a breath responsive variable bolus oxygen conserving device:

    1. support increased activity
    2. improve quality of life
    3. increase functional capability
    4. reduce portable oxygen source utilization
    5. maintain and/or improve oxygen saturation
Device: Breath Responsive Variable Bolus Oxygen Conserving Device
Mini Electronic Oxygen Conserving Device
Other Names:
  • SmartDose®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline once upon entry into the study
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)
Every two weeks after baseline up to three months
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
At baseline upon study entry and change from baseline every two weeks up to three months
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
At baseline upon study entry and change from baseline every two weeks up to three months
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
At baseline upon study entry and change from baseline every two weeks up to three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StratiHealth

Collaborators

University of Pennsylvania
Kaiser Permanente

Investigators

  • Principal Investigator: ISABEL PEREIRA, MD, StratiHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01012015DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be submitted for publication in peer review

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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