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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03187236
Recruitment Status : Unknown
Verified June 2017 by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Description
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Brief Summary:
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.

Condition or disease
COPD Anxiety Depression

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1906 participants
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
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. moderate and severe COPD exacerbations [ Time Frame: 3 years ]
    total times


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 3 years ]
    mortality in %


Biospecimen Retention:   Samples With DNA
Serum and blood cells

Eligibility Criteria
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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Stable COPD patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187236


Contacts
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Contact: Jiangna Han, MD 13520053104 13520053104@139.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Jiangna Han, MD    13520053104    13520053104@139.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03187236    
Other Study ID Numbers: 2016YFC1304404A
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Lung Diseases
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes