Interstitial Lung DiseaseNCT02479126
Interstitial Lung Diseases in the Veterans Administration
An observational study of Interstitial Lung Disease, run by Robert Tighe at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults with encounters at any VISN6 healthcare facility during specified time period
Who may be able to join
- Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3
Who cannot join
- Inadequate documentation of patient receiving care for ILD in the health records
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Electronic Health Records, Computed Tomography, Mortality, Hospitalization, Acute care visits, Anti-inflammatory drug therapies
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population
Measured: up to 5 years
Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population
Measured: up to 5 years
Secondary outcomes (3)
Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease
Will compare the reported ICD-9 code diagnosis with the diagnosis made after chart review and re-interpretation of the lung imaging and pathology
Measured: up to 5 years
Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider
Measured: up to 5 years
Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease
Compare the prevalence of diabetes with interstitial lung disease as compared to the prevalence of diabetes in the general VA population
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2016
- Primary completionNov 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Tighe
- Sponsor type
- US federal agency
- Collaborators
- Durham VA Medical Center, Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Robert Tighe, Durham VA Medical Center
- Investigators
- Robert M Tighe, MD, Principal investigator, Duke University Department of Medicine and Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479126
- Sponsor's protocol ID
- 01882
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2015
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes
- ClinicalTrials.gov ID
- NCT02479126
- Acronym / sponsor ID
- 01882
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Electronic Health Records, Computed Tomography, Mortality, Hospitalization, Acute care visits, Anti-inflammatory drug therapies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Robert TigheUS federal agency
- Collaborators
- Durham VA Medical Center, Boehringer Ingelheim
- Study start
- Jul 2016
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with encounters at any VISN6 healthcare facility during specified time period
Key inclusion criteria (1 listed)
- Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3
Key exclusion criteria (1 listed)
- Inadequate documentation of patient receiving care for ILD in the health records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease
Time frame: up to 5 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Tighe, MD principal investigator
Duke University Department of Medicine and Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Robert Tighe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.