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Interstitial Lung Diseases in the Veterans Administration

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: NCT02479126
Recruitment Status : Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Durham VA Medical Center
Boehringer Ingelheim
Information provided by (Responsible Party):
Robert Tighe, Durham VA Medical Center

Tracking Information
First Submitted Date June 19, 2015
First Posted Date June 24, 2015
Last Update Posted Date May 3, 2019
Study Start Date July 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2015)
  • Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population [ Time Frame: up to 5 years ]
  • Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population [ Time Frame: up to 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02479126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 22, 2015)
  • Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease [ Time Frame: up to 5 years ]
    Will compare the reported ICD-9 code diagnosis with the diagnosis made after chart review and re-interpretation of the lung imaging and pathology
  • Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider [ Time Frame: up to 5 years ]
  • Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease [ Time Frame: up to five years ]
    Compare the prevalence of diabetes with interstitial lung disease as compared to the prevalence of diabetes in the general VA population
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Interstitial Lung Diseases in the Veterans Administration
Official Title Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes
Brief Summary The primary objective of this research project is to describe the characteristics, diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5 years.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All adults with encounters at any VISN6 healthcare facility during specified time period
Condition Interstitial Lung Disease
Intervention Not Provided
Study Groups/Cohorts Interstitial Lung Disease
Patients will be identified from a specified 5 year period based on an International Classification of Diseases-9 (ICD-9) code diagnosis of Interstitial Lung disease (515) or Idiopathic Pulmonary Fibrosis (516.3). The patients will be obtained from the records of the Veterans Integrated Service Network (VISN) 6: VA Mid-Atlantic Health Care Network.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 22, 2015)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3

Exclusion Criteria:

  • Inadequate documentation of patient receiving care for ILD in the health records
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02479126
Other Study ID Numbers 01882
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert Tighe, Durham VA Medical Center
Study Sponsor Robert Tighe
Collaborators
  • Durham VA Medical Center
  • Boehringer Ingelheim
Investigators
Principal Investigator: Robert M Tighe, MD Duke University Department of Medicine and Durham VA Medical Center
PRS Account Durham VA Medical Center
Verification Date May 2019