Chronic Obstructive Pulmonary DiseaseACENCT02740465
Anxiety and COPD Evaluation
A study testing Anxiety Inventory for Respiratory Disease (AIR) and Hospital Anxiety and Depression Scale (HADS) in people with Chronic Obstructive Pulmonary Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This prospective, multicenter, cohort study is designed to validate Anxiety Inventory Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Anxiety Inventory for Respiratory Disease (AIR) and Hospital Anxiety and Depression Scale (HADS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Mar 2019
- Phase
- Interventional
- 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
Who may be able to join
- Post-bronchodilation FEV1 < 80% of the predictive normal value and FEV1 (forced expiratory volume in one second) / Forced vital capacity(FVC) ratio < 0.7
- Clinically stable COPD as defined by stable maintenance of COPD medications and absence of an exacerbation of symptoms requiring treatment with an antibiotic or corticosteroids
Who cannot join
- Exacerbation of respiratory symptoms in the past six weeks that resulted in the need for treatment or hospitalization
- Unstable coronary heart disease such as recent myocardial infarction (within 3 months), untreated arrhythmia, or unstable angina
- Major psychiatric disorders (except for depression and anxiety disorders) such as schizophrenia, schizoaffective, or other disorders that in the opinion of the study physician that would affect study participation
- Montreal Cognitive Assessment (MoCA) < 18
- Disease or condition expected to cause death within six months or inability to perform study procedures, as judged by study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Anxiety and COPD Evaluation (ACE)
This prospective, multicenter, cohort study is designed to validate Anxiety Inventory Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease (COPD).
The primary purpose of this study is to assess the validity of the Anxiety Inventory Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients with COPD.
- To evaluate associations between COPD symptom scores assessed by the CAT questionnaire and MMRC dyspnea scale and measures of depression and anxiety
- To evaluate associations between physiologic measures of lung function (spirometry) and exercise tolerance (6 minute walk) and measures of depression and anxiety
- To evaluate associations between exacerbations of COPD and the prevalence of anxiety and depression in a cohort of COPD patients
Read the detailed description
The goal of the Anxiety and COPD Evaluation (ACE) study is to validate the AIR scale by employing the Mini International Neuropsychiatric Interview to identify anxiety in 200 patients recruited at participating centers from the American Lung Association (ALA) Airways Research Network.
Confidential, not
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Anxiety Inventory for Respiratory Disease (AIR), Hospital Anxiety and Depression Scale (HADS)
- Keywords
- ACE, Anxiety, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Inventory for Respiratory Disease (AIR)Behavioural
An initial version of the AIR was developed through a mixed-methods approach to item development, incorporating both emic and etic perspectives. This included an extensive review of extant anxiety scales (etic perspectives) and in-depth qualitative interviews with patients with COPD and self-reported anxiety (emic perspectives). AIR has ten items on a scale from 0 to 3. It provides a score of 0-30. High score indicates elevated level of clinically relevant anxiety symptoms.
Hospital Anxiety and Depression Scale (HADS)Behavioural
The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Experimental | Not described Receives: Behavioral: Anxiety Inventory for Respiratory Disease (AIR); Behavioral: Hospital Anxiety and Depression Scale (HADS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) was developed as a brief screening instrument to detect mild cognitive impairment. It is a paper-and-pencil tool that requires approximately 10 minutes to administer, and is scored out of 30 points. The MoCA assesses multiple cognitive domains including attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. It is widely used around the world and is translated to 36 languages and dialects.
Measured: 10 Minutes
COPD Assessment Test (CAT)
The CAT is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT is quick and easy for patients to complete and, without complex calculations, provides a score of 0-40 to indicate the impact of disease.
Measured: 10 Minutes
Modified Medical Research Council dyspnea scale (MMRC)
The MMRC uses a simple grading system to assess a patient's level of dyspnea and has been used for many years for grading the effects of breathlessness on daily activities. This scale has been particularly used in patients with chronic obstructive pulmonary disease (COPD) in whom it has proved to be useful and complementary to First Forced expiratory volume (FEV1) in the classification of disease severity.
Measured: 10 Minutes
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Measured: 1-month time interval
Patient-Reported Outcomes Measurement Information System Questionnaires: Emotional Distress-Anxiety Function -(PROMIS-29)
These patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. The NIH funded leading PRO and clinical investigators to develop a "psychometrically validated, dynamic system to measure PROs efficiently in study participants with a wide range of chronic diseases and demographic characteristics." The PROMIS initiative is part of the NIH goal to develop systems to support NIH-funded research supported by all of its institutes and centers. PROMIS measures cover physical, mental, and social health and can be used across chronic conditions.
Measured: 10 Minutes
Patient-Reported Outcomes Measurement Information System Questionnaires: Physical Function - Short Form 20a (PROMIS-20a)
Measured: 10 Minutes
EuroQol EQ-5D- 5L
The EQ-5D-5L is a generic measure of health related quality of life that can be calibrated on a 0 to 1 scale and thus measures utility, allowing for the calculation of Quality Adjusted Life Years (QALYs). The standard EQ-5D measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression graded from level 1 (i.e., no problems) to level 5 (i.e., extreme problems). Use of the 5-levels (EQ-5D-5L) rather than the standard 3 level EQ-5D (EQ-5D-3L) has led to less ceiling effect, greater discriminative ability, and potentially more power to detect differences between groups compared with EQ-5D-3L.
Measured: 10 Minutes
Patient Health Questionnaire for Depression (PHQ9)
The Patient Health Questionnaire is a diagnostic tool for mental health disorders used by health care professionals that is quick and easy for patients to complete.
Measured: 2 Days
Patient Health Questionnaire for Anxiety (GAD7)
A brief scale for anxiety and scores seven common anxiety symptoms.
Measured: 2 Days
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.
Measured: 2 Days
Mini International Neuropsychiatric Interview (MINI)
Participants will be interviewed for unipolar major depression and anxiety disorders using the MINI, version 7.0 which conforms to the Diagnostic and Statistical Manual of Mental (DSM) Disorders.
Measured: 10 Minutes
6 Minute Walk Distance
The purpose of the six minute walk is test exercise tolerance in chronic respiratory disease and heart failure. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in that time. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: 6 Minutes
Pulmonary function Spirometry pre and post bronchodilator
Spirometry is a common office test used to diagnose asthma, chronic obstructive pulmonary disease (COPD), and certain other conditions that affect breathing. Spirometry measures how much air inhaled and exhaled and how fast.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Reibman, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740465
- Sponsor's protocol ID
- 15-00336
- Acronym
- ACE
- Status last verified
- Mar 2019
- First submitted
- 12 Apr 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and COPD Evaluation (ACE)
- ClinicalTrials.gov ID
- NCT02740465
- Acronym / sponsor ID
- ACE / 15-00336
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- ACE, Anxiety, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 15 Apr 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.
This prospective, multicenter, cohort study is designed to validate Anxiety Inventory Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease (COPD).
The primary purpose of this study is to assess the validity of the Anxiety Inventory Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients with COPD.
- To evaluate associations between COPD symptom scores assessed by the CAT questionnaire and MMRC dyspnea scale and measures of depression and anxiety
- To evaluate associations between physiologic measures of lung function (spirometry) and exercise tolerance (6 minute walk) and measures of depression and anxiety
- To evaluate associations between exacerbations of COPD and the prevalence of anxiety and depression in a cohort of COPD patients
Detailed description
The goal of the Anxiety and COPD Evaluation (ACE) study is to validate the AIR scale by employing the Mini International Neuropsychiatric Interview to identify anxiety in 200 patients recruited at participating centers from the American Lung Association (ALA) Airways Research Network.
Confidential, not
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | Experimental | Behavioral: Anxiety Inventory for Respiratory Disease (AIR), Behavioral: Hospital Anxiety and Depression Scale (HADS) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-bronchodilation FEV1 < 80% of the predictive normal value and FEV1 (forced expiratory volume in one second) / Forced vital capacity(FVC) ratio < 0.7
- Clinically stable COPD as defined by stable maintenance of COPD medications and absence of an exacerbation of symptoms requiring treatment with an antibiotic or corticosteroids
Key exclusion criteria (5 listed)
- Exacerbation of respiratory symptoms in the past six weeks that resulted in the need for treatment or hospitalization
- Unstable coronary heart disease such as recent myocardial infarction (within 3 months), untreated arrhythmia, or unstable angina
- Major psychiatric disorders (except for depression and anxiety disorders) such as schizophrenia, schizoaffective, or other disorders that in the opinion of the study physician that would affect study participation
- Montreal Cognitive Assessment (MoCA) < 18
- Disease or condition expected to cause death within six months or inability to perform study procedures, as judged by study physician
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 |
|---|---|---|
| Anxiety Inventory for Respiratory Disease (AIR)An initial version of the AIR was developed through a mixed-methods approach to item development, incorporating both emic and etic perspectives. This included an extensive review of extant anxiety scales (etic perspectives) and in-depth qualitative interviews with patients with COPD and self-reported anxiety (emic perspectives). AIR has ten items on a scale from 0 to 3. It provides a score of 0-30. High score indicates elevated level of clinically relevant anxiety symptoms. | Behavioural | COPD Patients |
| Hospital Anxiety and Depression Scale (HADS)The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems. | Behavioural | COPD Patients |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 10 Minutes
The Montreal Cognitive Assessment (MoCA) was developed as a brief screening instrument to detect mild cognitive impairment. It is a paper-and-pencil tool that requires approximately 10 minutes to administer, and is scored out of 30 points. The MoCA assesses multiple cognitive domains including attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. It is widely used around the world and is translated to 36 languages and dialects.
COPD Assessment Test (CAT)
Time frame: 10 Minutes
The CAT is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT is quick and easy for patients to complete and, without complex calculations, provides a score of 0-40 to indicate the impact of disease.
Modified Medical Research Council dyspnea scale (MMRC)
Time frame: 10 Minutes
The MMRC uses a simple grading system to assess a patient's level of dyspnea and has been used for many years for grading the effects of breathlessness on daily activities. This scale has been particularly used in patients with chronic obstructive pulmonary disease (COPD) in whom it has proved to be useful and complementary to First Forced expiratory volume (FEV1) in the classification of disease severity.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1-month time interval
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Patient-Reported Outcomes Measurement Information System Questionnaires: Emotional Distress-Anxiety Function -(PROMIS-29)
Time frame: 10 Minutes
These patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. The NIH funded leading PRO and clinical investigators to develop a "psychometrically validated, dynamic system to measure PROs efficiently in study participants with a wide range of chronic diseases and demographic characteristics." The PROMIS initiative is part of the NIH goal to develop systems to support NIH-funded research supported by all of its institutes and centers. PROMIS measures cover physical, mental, and social health and can be used across chronic conditions.
Patient-Reported Outcomes Measurement Information System Questionnaires: Physical Function - Short Form 20a (PROMIS-20a)
Time frame: 10 Minutes
EuroQol EQ-5D- 5L
Time frame: 10 Minutes
The EQ-5D-5L is a generic measure of health related quality of life that can be calibrated on a 0 to 1 scale and thus measures utility, allowing for the calculation of Quality Adjusted Life Years (QALYs). The standard EQ-5D measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression graded from level 1 (i.e., no problems) to level 5 (i.e., extreme problems). Use of the 5-levels (EQ-5D-5L) rather than the standard 3 level EQ-5D (EQ-5D-3L) has led to less ceiling effect, greater discriminative ability, and potentially more power to detect differences between groups compared with EQ-5D-3L.
Patient Health Questionnaire for Depression (PHQ9)
Time frame: 2 Days
The Patient Health Questionnaire is a diagnostic tool for mental health disorders used by health care professionals that is quick and easy for patients to complete.
Patient Health Questionnaire for Anxiety (GAD7)
Time frame: 2 Days
A brief scale for anxiety and scores seven common anxiety symptoms.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 Days
The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.
Mini International Neuropsychiatric Interview (MINI)
Time frame: 10 Minutes
Participants will be interviewed for unipolar major depression and anxiety disorders using the MINI, version 7.0 which conforms to the Diagnostic and Statistical Manual of Mental (DSM) Disorders.
6 Minute Walk Distance
Time frame: 6 Minutes
The purpose of the six minute walk is test exercise tolerance in chronic respiratory disease and heart failure. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in that time. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Pulmonary function Spirometry pre and post bronchodilator
Time frame: 2 Days
Spirometry is a common office test used to diagnose asthma, chronic obstructive pulmonary disease (COPD), and certain other conditions that affect breathing. Spirometry measures how much air inhaled and exhaled and how fast.
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 22 Mar 2019.
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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.
Joan Reibman, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Inventory for Respiratory Disease (AIR) and Hospital Anxiety and Depression Scale (HADS) in people with Chronic Obstructive Pulmonary Disease, 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 2 inclusion and 5 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 22 Mar 2019. 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?
Montreal Cognitive Assessment (MoCA) (time frame: 10 Minutes). The study lists 13 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 22 Mar 2019.