Registry for Chronic Obstructive Pulmonary Disease With Anxiety and Depression in China


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Verified June 2017 by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor:

Information provided by (Responsible Party):

Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

ClinicalTrials.gov Identifier:

NCT03187236

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: June 2017

Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.

COPD
Anxiety
Depression

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Early Detection, Clinical Course and Prognosis of Anxiety and Depression in Chronic Obstructive Pulmonary Disease

Primary Outcome Measures:

  • moderate and severe COPD exacerbations [ Time Frame: 3 years ]

    total times

Secondary Outcome Measures:

  • All-cause mortality [ Time Frame: 3 years ]

    mortality in %

Biospecimen Retention:   Samples With DNA

Serum and blood cells

Estimated Enrollment: 1906
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample

Stable COPD patients

Inclusion Criteria:

  • Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria:

  • Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
  • Patients with tumor history during past 5 years
  • Patients with COPD exacerbations during past 4 weeks
  • Participants in clinical trials
  • Patients in pregnancy or breastfeeding
  • Patients unable to complete questionaire independently
  • Patients older than 80 years old
  • Patients receiving long-term domiciliary oxygen therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03187236

Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Contact: Jiangna Han, MD    13520053104    13520053104@139.com   

Chinese Academy of Medical Sciences, Fuwai Hospital

Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03187236     History of Changes
Other Study ID Numbers: 2016YFC1304404A
Study First Received: June 13, 2017
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression
Depressive Disorder
Lung Diseases
Anxiety Disorders
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 14, 2017