NCT01074515

Brief Summary

The goal of the study is to look at how genes and certain chemicals in the body are related to depression and chronic obstructive pulmonary disease.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

February 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

6 years

First QC Date

February 11, 2010

Last Update Submit

December 1, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDDepressionInflammationGeneticsFunctioningDyspneaPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Depression

    1 year & 2 year

Secondary Outcomes (4)

  • Physical activity by accelerometry

    1 year & 2 year

  • Dyspnea

    1 year & 2 year

  • Health related quality of life

    1 year & 2 year

  • Six Minute Walk Distance

    1 year & 2 year

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pulmonary and primary care clinics and community sample

You may qualify if:

  • Diagnosis of COPD confirmed by the following: 1) FEV1/FVC \< 70%; 2) Moderate to very severe disease by GOLD criteria (FEV1 \<65%); 2) Age \> 40 years; and 3) A significant history of current or past cigarette smoking (\> 10 pack-years);
  • Stable disease with no acute exacerbations of COPD in the past 4 weeks;
  • Ability to speak, read and write English

You may not qualify if:

  • Chronic obstructive lung disorders unrelated to COPD: asthma, bronchiectasis, cystic fibrosis
  • Idiopathic Pulmonary Fibrosis
  • Congestive Heart Failure
  • Chronic renal failure requiring dialysis
  • Primary pulmonary vascular disease
  • Chronic inflammatory, infectious or auto-immune disease, e.g. osteomyelitis, crohn's disease or rheumatoid arthritis
  • Chronic liver disease
  • Metastatic cancer
  • Chronic antibiotic use or ongoing infection
  • Chronic oral prednisone use
  • Moderate to severe dementia
  • Severe primary mental illness, e.g. schizophrenia, bipolar disease, severe obsessive compulsive disorder
  • \<2 years life expectancy
  • History of fainting with spirometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Puget Sound Veterans Administration Health Care System

Seattle, Washington, 98108, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Chen Z, Fan VS, Belza B, Pike K, Nguyen HQ. Association between Social Support and Self-Care Behaviors in Adults with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2017 Sep;14(9):1419-1427. doi: 10.1513/AnnalsATS.201701-026OC.

    PMID: 28719225DERIVED

  • Nguyen HQ, Herting JR, Pike KC, Gharib SA, Matute-Bello G, Borson S, Kohen R, Adams SG, Fan VS. Symptom profiles and inflammatory markers in moderate to severe COPD. BMC Pulm Med. 2016 Dec 3;16(1):173. doi: 10.1186/s12890-016-0330-1.

    PMID: 27914470DERIVED

  • Nguyen HQ, Fan VS, Herting J, Lee J, Fu M, Chen Z, Borson S, Kohen R, Matute-Bello G, Pagalilauan G, Adams SG. Patients with COPD with higher levels of anxiety are more physically active. Chest. 2013 Jul;144(1):145-151. doi: 10.1378/chest.12-1873.

    PMID: 23370503DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDepressionInflammationDyspneaMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Huong Q Nguyen, PhD, RN

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Vincent Fan, MD, MPH

    Puget Sound Veteran's Affair

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal investigator

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 24, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(4)