COPDSODANCT02771262
Making Sense of Dyspnea Assessment
An observational study of COPD and Dyspnea, run by NYU Langone Health at 1 site in United States.
Trial summary
Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO). It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD). There is a high priority to improve dyspnea PRO assessment and predict exacerbations. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Pulmonary Rehabilitation
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 1 Feb 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Chronic Obstructive Pulmonary Disease
Who may be able to join
- English Speaking
- Over 40 years of age
- Physician-diagnosed COPD documented in their clinic notes
- Have at least one pulmonary function test (PFT) with a pre-bronchodilator or post-bronchodilator ratio of forced expiratory volume in one second divided by the forced vital capacity (FEV1/ FVC) OF < 0.70 and/or evidence of COPD on chest computed tomography (CT)
Who cannot join
- Neurological dysfunction that interferes with their participation in the pulmonary rehabilitation program
- Are unable to provide informed consent
- PR participants who are hospitalized during their PR program will be excluded from further evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Health
New York, New York, 10016
About this study
Official title: Interpreting COPD Dyspnea Change: Sensitivity, Responsiveness, and Predictive Validity of the Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT)
Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO). It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD). There is a high priority to improve dyspnea PRO assessment and predict exacerbations. Frequent exacerbations are associated with increased disability, decreased quality of life (QOL), and accelerated lung function decline.
Goals: To test the relative sensitivity to change, responsiveness and predictive validity of a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and activity avoidance domains and is more efficient to administer than existing dyspnea scales.
Read more
Expected Outcomes: Investigators expect to:
- begin to transform how dyspnea is assessed;
- improve dyspnea symptom management;
- impact functional status;
- improve QOL;
- facilitate the earlier treatment and prevention of exacerbations;
- improve COPD prognosis and survival; and
- improve COPD healthcare utilization.
Read the detailed description
Theoretical Background: COPD research and practice has focused predominately on evaluating and treating the sensory component of dyspnea. However, dyspnea (like pain) is a complex symptom with sensory and affective components. Current dyspnea scales are limited in scope by only measuring the sensory component of dyspnea, and have high respondent and data collection burden and/or high measurement error. Only sensory dyspnea to date has been used to classify COPD severity. The DMQ-CAT addresses the limitations of other dyspnea scales by using state-of-the-art item banking method techniques to provide a tailored multidimensional dyspnea assessment using only a minimal number of items. The 71-item DMQ-CAT captures four distinct dyspnea constructs: intensity, anxiety, activity avoidance, and self-efficacy to evaluate outcomes of COPD pharmacologic, pulmonary rehabilitation, and cognitive-behavioral therapy. The DMQ-CAT showed evidence of minimal ceiling and floor effects, acceptable Rasch model fit statistics, high internal consistency reliability, good accuracy compared to the total item pool, and good to excellent concurrent and known-groups validity. The relative sensitivity to change, responsiveness, and predictive validity of the DMQ-CAT is not currently known.
Hypotheses: The DMQ-CAT has superior sensitivity to change and responsiveness compared to other widely used COPD dyspnea scales. The DMQ-CAT has superior predictive validity compared to other dyspnea measures to predict acute COPD exacerbation incidence and severity.
Study Design: To achieve Aims 1 and 2, the investigators will use a prospective observational design and a target sample of 110 pulmonary rehabilitation (PR) outpatients with COPD. The investigators will use distribution-based statistics to compare the sensitivity to change of dyspnea instruments including: effect sizes, standardized response means (SRM), standardized error of measurement (SEM), and the percentage of participants exceeding the minimal detectable change (MDC90) from baseline to discharge from PR. The investigators will estimate the minimal clinically important difference (MCID) for the DMQ-CAT and compare the percentage of participants exceeding MCID thresholds using established MCIDs for dyspnea instruments. For Aim 3, the investigators will use a retrospective observational design to conduct secondary analyses from existing data of 240 patients with COPD. The investigators will use odds ratios (OR) and 95% confidence interval (CI) and the area under the receiver operator curve (ROC) to compare the predictive validity of different dyspnea measures.
- Being tested
- Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT)
DMQ-CAT scales: Intensity, Anxiety, Activity avoidance, Self-efficacy
Measured: Through completion of pulmonary rehabilitation program (8 or 12 weeks on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startOct 2014
- Primary completion2 Aug 2019
- Study completion1 Feb 2020
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, VA Boston Healthcare System, National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Anna M Norweg, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771262
- Sponsor's protocol ID
- 16-02088
- Acronym
- SODA
- Status last verified
- May 2020
- First submitted
- 5 May 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpreting COPD Dyspnea Change: Sensitivity, Responsiveness, and Predictive Validity of the Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT)
- ClinicalTrials.gov ID
- NCT02771262
- Acronym / sponsor ID
- SODA / 16-02088
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Boston University, VA Boston Healthcare System, National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- Oct 2014 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 13 May 2016 (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.
Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO). It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD). There is a high priority to improve dyspnea PRO assessment and predict exacerbations. Frequent exacerbations are associated with increased disability, decreased quality of life (QOL), and accelerated lung function decline.
Goals: To test the relative sensitivity to change, responsiveness and predictive validity of a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and activity avoidance domains and is more efficient to administer than existing dyspnea scales.
Expected Outcomes: Investigators expect to:
- begin to transform how dyspnea is assessed;
- improve dyspnea symptom management;
- impact functional status;
- improve QOL;
- facilitate the earlier treatment and prevention of exacerbations;
- improve COPD prognosis and survival; and
- improve COPD healthcare utilization.
Detailed description
Theoretical Background: COPD research and practice has focused predominately on evaluating and treating the sensory component of dyspnea. However, dyspnea (like pain) is a complex symptom with sensory and affective components. Current dyspnea scales are limited in scope by only measuring the sensory component of dyspnea, and have high respondent and data collection burden and/or high measurement error. Only sensory dyspnea to date has been used to classify COPD severity. The DMQ-CAT addresses the limitations of other dyspnea scales by using state-of-the-art item banking method techniques to provide a tailored multidimensional dyspnea assessment using only a minimal number of items. The 71-item DMQ-CAT captures four distinct dyspnea constructs: intensity, anxiety, activity avoidance, and self-efficacy to evaluate outcomes of COPD pharmacologic, pulmonary rehabilitation, and cognitive-behavioral therapy. The DMQ-CAT showed evidence of minimal ceiling and floor effects, acceptable Rasch model fit statistics, high internal consistency reliability, good accuracy compared to the total item pool, and good to excellent concurrent and known-groups validity. The relative sensitivity to change, responsiveness, and predictive validity of the DMQ-CAT is not currently known.
Hypotheses: The DMQ-CAT has superior sensitivity to change and responsiveness compared to other widely used COPD dyspnea scales. The DMQ-CAT has superior predictive validity compared to other dyspnea measures to predict acute COPD exacerbation incidence and severity.
Study Design: To achieve Aims 1 and 2, the investigators will use a prospective observational design and a target sample of 110 pulmonary rehabilitation (PR) outpatients with COPD. The investigators will use distribution-based statistics to compare the sensitivity to change of dyspnea instruments including: effect sizes, standardized response means (SRM), standardized error of measurement (SEM), and the percentage of participants exceeding the minimal detectable change (MDC90) from baseline to discharge from PR. The investigators will estimate the minimal clinically important difference (MCID) for the DMQ-CAT and compare the percentage of participants exceeding MCID thresholds using established MCIDs for dyspnea instruments. For Aim 3, the investigators will use a retrospective observational design to conduct secondary analyses from existing data of 240 patients with COPD. The investigators will use odds ratios (OR) and 95% confidence interval (CI) and the area under the receiver operator curve (ROC) to compare the predictive validity of different dyspnea measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Chronic Obstructive Pulmonary Disease
Key inclusion criteria (4 listed)
- English Speaking
- Over 40 years of age
- Physician-diagnosed COPD documented in their clinic notes
- Have at least one pulmonary function test (PFT) with a pre-bronchodilator or post-bronchodilator ratio of forced expiratory volume in one second divided by the forced vital capacity (FEV1/ FVC) OF < 0.70 and/or evidence of COPD on chest computed tomography (CT)
Key exclusion criteria (3 listed)
- Neurological dysfunction that interferes with their participation in the pulmonary rehabilitation program
- Are unable to provide informed consent
- PR participants who are hospitalized during their PR program will be excluded from further evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation | Other | – |
Primary outcome
Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT)
Time frame: Through completion of pulmonary rehabilitation program (8 or 12 weeks on average)
DMQ-CAT scales: Intensity, Anxiety, Activity avoidance, Self-efficacy
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 28 May 2020.
- Individual participant dataSharing planned: No
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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.
Anna M Norweg, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Dyspnea, run by NYU Langone Health at 1 site 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 4 inclusion and 3 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) (time frame: Through completion of pulmonary rehabilitation program (8 or 12 weeks on average)). 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 28 May 2020.