NCT03187236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,906

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

June 13, 2017

Last Update Submit

June 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • moderate and severe COPD exacerbations

    total times

    3 years

Secondary Outcomes (1)

  • All-cause mortality

    3 years

Eligibility Criteria

AgeUp to 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable COPD patients

You may qualify if:

  • Stable chronic obstructive pulmonary disease (COPD) patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Related Publications (1)

  • Zhao X, Su R, Hu R, Chen Y, Xu X, Yuan Y, Zhang J, Zhang W, Yang Y, Chen M, Li D, Wu B, Huang D, Wu D. Sarcopenia index as a predictor of clinical outcomes among older adult patients with acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study. BMC Geriatr. 2023 Feb 11;23(1):89. doi: 10.1186/s12877-023-03784-7.

Biospecimen

Retention: SAMPLES WITH DNA

Serum and blood cells

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Jiangna Han, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 14, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations