Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments anxiety inventory for respiratory disease (air), hospital anxiety and depression scale (hads)
Sponsor New York University School of Medicine
Start date January 2016
End date March 2017
Trial size 200 participants
Trial identifier NCT02740465, 15-00336

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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.

Primary Outcomes

Measure
Montreal Cognitive Assessment (MoCA)
time frame: 10 Minutes
COPD Assessment Test (CAT)
time frame: 10 Minutes
Modified Medical Research Council dyspnea scale (MMRC)
time frame: 10 Minutes
Pittsburgh Sleep Quality Index (PSQI)
time frame: 1-month time interval
Patient-Reported Outcomes Measurement Information System Questionnaires: Emotional Distress—Anxiety Function -(PROMIS-29)
time frame: 10 Minutes
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
Patient Health Questionnaire for Depression (PHQ9)
time frame: 2 Days
Patient Health Questionnaire for Anxiety (GAD7)
time frame: 2 Days
Hospital Anxiety and Depression Scale (HADS)
time frame: 2 Days
Mini International Neuropsychiatric Interview (MINI)
time frame: 10 Minutes
6 Minute Walk Distance
time frame: 6 Minutes
Pulmonary function Spirometry pre and post bronchodilator
time frame: 2 Days

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Anxiety and COPD Evaluation (ACE)
Principal investigator Joan Reibman, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.