Clinical trial NCT02740465: Anxiety and COPD Evaluation
Official title: Anxiety and COPD Evaluation (ACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: ACE
Anxiety
COPD
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 10 Minutes
measure: COPD Assessment Test (CAT)
timeFrame: 10 Minutes
measure: Modified Medical Research Council dyspnea scale (MMRC)
timeFrame: 10 Minutes
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1-month time interval
measure: Patient-Reported Outcomes Measurement Information System Questionnaires: Emotional Distress-Anxiety Function -(PROMIS-29)
timeFrame: 10 Minutes
measure: Patient-Reported Outcomes Measurement Information System Questionnaires: Physical Function - Short Form 20a (PROMIS-20a)
timeFrame: 10 Minutes
measure: EuroQol EQ-5D- 5L
timeFrame: 10 Minutes
measure: Patient Health Questionnaire for Depression (PHQ9)
timeFrame: 2 Days
measure: Patient Health Questionnaire for Anxiety (GAD7)
timeFrame: 2 Days
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 Days
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: 10 Minutes
measure: 6 Minute Walk Distance
timeFrame: 6 Minutes
measure: Pulmonary function Spirometry pre and post bronchodilator
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Joan Reibman, MD
role: PRINCIPAL_INVESTIGATOR
References: