Back to resultsAnxiety and COPD Evaluation (ACE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Inventory for Respiratory Disease (AIR)
Hospital Anxiety and Depression Scale (HADS)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring ACE, Anxiety, COPD
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD Patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Patient-Reported Outcomes Measurement Information System Questionnaires: Physical Function - Short Form 20a (PROMIS-20a)
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.
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.
Patient Health Questionnaire for Anxiety (GAD7)
A brief scale for anxiety and scores seven common anxiety symptoms.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02740465
Brief Title
Anxiety and COPD Evaluation
Acronym
ACE
Official Title
Anxiety and COPD Evaluation (ACE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
ACE, Anxiety, COPD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD Patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Inventory for Respiratory Disease (AIR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hospital Anxiety and Depression Scale (HADS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
10 Minutes
Title
COPD Assessment Test (CAT)
Description
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.
Time Frame
10 Minutes
Title
Modified Medical Research Council dyspnea scale (MMRC)
Description
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.
Time Frame
10 Minutes
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
1-month time interval
Title
Patient-Reported Outcomes Measurement Information System Questionnaires: Emotional Distress-Anxiety Function -(PROMIS-29)
Description
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.
Time Frame
10 Minutes
Title
Patient-Reported Outcomes Measurement Information System Questionnaires: Physical Function - Short Form 20a (PROMIS-20a)
Time Frame
10 Minutes
Title
EuroQol EQ-5D- 5L
Description
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.
Time Frame
10 Minutes
Title
Patient Health Questionnaire for Depression (PHQ9)
Description
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.
Time Frame
2 Days
Title
Patient Health Questionnaire for Anxiety (GAD7)
Description
A brief scale for anxiety and scores seven common anxiety symptoms.
Time Frame
2 Days
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
2 Days
Title
Mini International Neuropsychiatric Interview (MINI)
Description
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.
Time Frame
10 Minutes
Title
6 Minute Walk Distance
Description
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.
Time Frame
6 Minutes
Title
Pulmonary function Spirometry pre and post bronchodilator
Description
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.
Time Frame
2 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Reibman, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Anxiety and COPD Evaluation
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