Investigating idiopathic pulmonary fibrosis in Greece (INDULGE IPF)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Registry

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Age groups:
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  300

Study design details

• Study design:
  This was a national, multi-center, observational disease registry based on new data from a significant sample size of IPF patients in Greece.
• Main study objective:
  The main objective of this IPF registry was to gain further knowledge on the characteristics, management, disease progression and outcomes of patients with IPF as diagnosed and treated under real-world, clinical practice ; conditions in Greece.More specifically, this registry aimed to:; • Provide a comprehensive clinical picture of IPF; • Track access to health care and cost of caring for IPF patients over ; time; • Examine the implementation of treatment guidelines used on ; patients diagnosed with IPF, according to the existing diagnosis ; guidelines; • Characterize patients on different treatments; Furthermore, this registry aimed to provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. In addition, data regarding IPF patient hospitalization would be collected and evaluated with regards to potential respiratory causes, and there would be documentation of treatment patterns and economic aspects.
• Setting:
  In order to ensure adequate patient numbers per center and high quality of data, seven (7) University Pulmonology Clinics and Reference Centers of Public Hospital Setting that follow up around 70%-80% of IPF patients within the Greek territory were involved. The registry was scheduled to run for 4 years in total (2 years recruitment + ; 2 years follow up) (April 2017 to Mar 2021).
• Data analysis plan:
  The nature of the statistical analyses will be exploratory and descriptive. Continuous variables will be listed as median with interquartile and other percentages, and as mean value with standard deviation (SD), along with minimum and maximum values (depending on the underlying distribution). Categorical values will be listed as absolute and relative frequencies. All events during follow up will be described as incidence rates with 95% confidence interval (CI). Stratified analyses will be performed among newly diagnosed patients (< 6 months) as well as patients that were diagnosed in the past (>= 6 months). In case of conflicting results those of the newly diagnosed will be the decisive. Due to limited number of patients and population heterogeneity, no comparison between treatments can be done and no causal relationship conclusion can be derived (no hypothesis testing). Statistical analyses will be performed with IBM SPSS Statistics (Version 19.0).