- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02479126
Interstitial Lung Diseases in the Veterans Administration
July 25, 2022 updated by: Robert Tighe
Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adults with encounters at any VISN6 healthcare facility during specified time period
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population
Time Frame: up to 5 years
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up to 5 years
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Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population
Time Frame: up to 5 years
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up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease
Time Frame: up to 5 years
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Will compare the reported ICD-9 code diagnosis with the diagnosis made after chart review and re-interpretation of the lung imaging and pathology
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up to 5 years
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Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider
Time Frame: up to 5 years
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up to 5 years
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Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease
Time Frame: up to five years
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Compare the prevalence of diabetes with interstitial lung disease as compared to the prevalence of diabetes in the general VA population
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up to five years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert M Tighe, MD, Duke University Department of Medicine and Durham VA Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
June 19, 2015
First Submitted That Met QC Criteria
June 22, 2015
First Posted (Estimate)
June 24, 2015
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01882
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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