NCT02479126

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.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 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 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

6.3 years

First QC Date

June 19, 2015

Last Update Submit

July 25, 2022

Conditions

Keywords

Interstitial Lung DiseaseIdiopathic Pulmonary FibrosisElectronic Health RecordsComputed TomographyMortalityHospitalizationAcute care visitsAnti-inflammatory drug therapies

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population

    up to 5 years

  • Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population

    up to 5 years

Secondary Outcomes (3)

  • Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease

    up to 5 years

  • Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider

    up to 5 years

  • Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease

    up to five years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults with encounters at any VISN6 healthcare facility during specified time period

You may qualify if:

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

You may not qualify if:

  • Inadequate documentation of patient receiving care for ILD in the health records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPulmonary Fibrosis

Study Officials

  • Robert M Tighe, MD

    Duke University Department of Medicine and Durham VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

July 1, 2016

Primary Completion

November 1, 2022

Study Completion

June 1, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations