COPDNCT01948544
Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by StratiHealth at 3 sites in United States.
Trial 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: 1. Exercise capability, dyspnea and quality of life as primary endpoints 2. Utilize: 1. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- COPD
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: COPD Patients prescreened and selected by their primary care physician or pulmonologist
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Tri-City Pulmonary Medical Group
Oceanside, California, 92054
Cardinal Medical Group
Vista, California, 92083
Pathway Medical Group
Westminster, California, 92683
About this study
Official title: 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:
- 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)
Read the 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).
- Conditions
- COPD
- Keywords
- COPD, LTOT, Long-Term Oxygen Therapy, Portable Oxygen Concentrator, Quality of Life, Six Minute Walk Distance Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Change in functional capability, dyspnea - BDI/TDI
- Change in exercise capability - 6MWT
Measured: 6 months
Quality of Life Using Chronic Respiratory Disease Questionnaire
Quality of life - Chronic Respiratory Disease Questionnaire
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- StratiHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabel Pereira, MD, Principal investigator, Tri-City Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948544
- Sponsor's protocol ID
- 01053013A
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2013
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Improvement in the Quality of Life and Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01948544
- Acronym / sponsor ID
- 01053013A
- Conditions
- COPD
- Keywords
- COPD, LTOT, Long-Term Oxygen Therapy, Portable Oxygen Concentrator, Quality of Life, Six Minute Walk Distance Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- StratiHealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- COPD Patients prescreened and selected by their primary care physician or pulmonologist
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Capacity
Time frame: 6 months
Change in functional capability, dyspnea - BDI/TDI • Change in exercise capability - 6MWT
Quality of Life Using Chronic Respiratory Disease Questionnaire
Time frame: 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
Quality of life - Chronic Respiratory Disease Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Pereira, MD principal investigator
Tri-City Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by StratiHealth at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.