Research of Burden of Interstititial Lung Diseases in Turkey (RBILD)

The aim of our study is to investigate the etiological distribution of ILD, epidemiological characteristics of ILD cases such as age, gender, geography, smoking, occupation, economic status, education, and comorbidities. Another aim is to make the cost calculation from the first to the diagnosis in the patients diagnosed. Obtaining the missing data related to the ILD of our country is one of our goals.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Diseases, Interstitial; Fibrosis Lung

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • Department Of Chest Diseases, School Of medicine, Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be a multicenter prospective cross-sectional study in Turkey, that will be the coordinating center of our Department of Chest Diseases

Description

Inclusion Criteria:

• Patients who are not previously diagnosed with ILD will be included in the study.

Exclusion Criteria:

• under 18 years old
• older 80 years old

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiological distribution	The aim of our study is to investigate the etiological distribution of ILD	1 year
Etiological distribution	Geographic distribution of ILD patients according to regions (will be presented as %)	1 year
Epidemiological characteristics of ILD cases	Age (years)	1 year
Epidemiological characteristics of ILD cases	Gender (male, female; (will be presented as %))	1 year
Epidemiological characteristics of ILD cases	Smoking (yes, no; (will be presented as %)	1 year
Epidemiological characteristics of ILD cases	Distribution of ILD patients according to the occupation (will be presented as %)	1 year
Epidemiological characteristics of ILD cases	Economic status (monthly salary of patients according to ILD types and stages of ILD)	1 year
Epidemiological characteristics of ILD cases	Distiribution of ILD patienst according to comorbidities (will be presented as YES or NO and %) Comorbiditites are; Hypertension, Heart failure, Coronary Artery Disease, Arrhythmia, Heart Valve Disease, Asthma, COPD, Chronic Renal Disease, Diabetes Mellitus, Hyper / Hypothyroidism, HIV, Cirrhosis / Chronic Liver Disease, Lung malignancy, Extrapulmonary solid organ malignancy, Hematologic malignancy, SVO, Alzeimer, Epilepsy, Neuromuscular Ill, Organ Transplant Receiver, Reflux, Slyding hernia, Others	1 year
Total number	We planned enroll roughly 1000 patients to the study	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical findings	According to the etiology of ILD, clinical findings (Rod, Ral, Rash, Arthritis, Alopecia, Erythema nodosum, Peripheral lymphadenomegaly, Cyanosis, Edema, Raynaud's phenomenon, Other) will be presented as YES or NO and %	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; FVC (ml) and (%pred)	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; FEV 1 (ml) and (%pred)	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; DLCO (mL.min.mmHg) and (%pred)	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; DLCO/VA (mL.min.mmHg) and (%pred) 6dk YT (meters) Pulseoksimetre ile PaO2 (%)	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; 6min Walk Test (meters)	1year
Pulmonary functions	According to the etiology of ILD, pulmonary functions, will be assessed; PaO2 with Pulse oximeter (%)	1year
Diagnostic methods	According to the etiology of ILD, diagnostic methods used in ILD cases will be presented Diagnoses methods are; Clinical and radiology, Bronchoscopic transbronchial lung biopsy, Bronchoalveolar lavage, Transthoracic needle biopsy with imaging, EBUS, VATS, Thoracotomy, Other (Methods are will be shown as YES or NO and %)	1year
Time	According to the etiology of ILD, the time spent for diagnosis will be presented Time will be presented as months.	1year
Treatment methods	Determining the treatment preferences of physicians according to the etiology of the cases will be presented; Treatment methods are; Non-treatment monitoring, Symptomatic treatment, Systemic corticosteroid, Cytostatic drugs, Antifibrosan drugs (eg Pirfenidone, Nintedanib), Immunological therapy, Referral to other centers, Preparing for transplantation, Home oxygen therapy, Reflux therapy, Other (Methods are will be shown as YES or NO and %)	1year

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Prevalence; Interstitial Lung Diseases; Fibrotic Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: 2018/176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical approve, IPD will not be shared with other researchers unless after ethical approves for any further study, researchers can ask for data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No