An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Nils Hoyer. Active, not recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Nils Hoyer · Observational
Patients with newly diagnosed IPF are investigated for the diagnostic delay before a diagnosis of IPF is made.
Pulmonary fibrosis can be secondary to connective-tissue disease, environmental exposure, or drug toxicity, but it can also appear sporadically without any known cause, i.e. idiopathic interstitial pneumonitis (IIP). Idiopathic pulmonary fibrosis (IPF) is the commonest IIP and usually follows a rapidly progressive course with a short median survival time.
IPF is often diagnosed after a long diagnostic delay, which also affects the prognosis. As new anti-fibrotic treatments have been approved, and awareness of IPF is rising, the diagnostic delay and its implications can be expected to be changing. Also, the new diagnostic guidelines of 2011 could change the diagnostic delay. In order to reduce the diagnostic delay, it is important to investigate the health care utilization and decisions made by healthcare professionals in the period before the final diagnosis is made.
This study will prospectively include all patients at the two centres in Denmark where patients are treated for IPF and has thus a good opportunity to include the majority of incident cases of IPF in Denmark. Patients are included immediately after the diagnosis which reduces recall bias. The database will include both patient reported data and objective data from national registries and patient records. A main focus is the distribution of the diagnostic delay between patient and different health care providers, and the health care utilization by the patients before a diagnosis of IPF is made. Risk factors for a delayed diagnosis are investigated. The importance of the diagnostic delay for the prognosis and the course of the disease will also be investigated.
The database created in this study will also be used for future research in IPF.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's planned enrollment of 300 is above the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Nils Hoyer is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All incident patients with IPF at Gentofte hospital and Aarhus university hospital.
Exclusion Criteria:
Number of patients who fulfil any of the following: disease progression or death
Time frame: 1 year
Number of patients who fulfill any of the following: decrease in lung function, reduced walking distance at 6 minutes walking test, increased need for supplementary oxygen, hospitalization
Time frame: 1 year
All-cause and disease-specific mortality
Time frame: 1 year
Number of respiratory and non-respiratory hospitalizations
Time frame: 1 year
Decrease in walking distance at the 6 minute walking test
Time frame: 1 year
Change in St. George Respiratory Questionnaire symptom scores
Time frame: 1 year
Reduction in diffusion capacity (DLCO) or forced vital capacity (FVC)
Time frame: 1 year
Diagnostic delays
Diagnostic delay subdivided into patient related delays and health care related delays.
Time frame: 1 year
Plan to share: Undecided
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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