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Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay

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ClinicalTrials.gov Identifier: NCT02772549
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nils Hoyer, University Hospital, Gentofte, Copenhagen

Brief Summary:
Patients with newly diagnosed IPF are investigated for the diagnostic delay before a diagnosis of IPF is made.

Condition or disease
Idiopathic Pulmonary Fibrosis

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Early Diagnosis of Pulmonary Fibrosis
Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023





Primary Outcome Measures :
  1. Number of patients who fulfil any of the following: disease progression or death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. All-cause and disease-specific mortality [ Time Frame: 1 year ]
  3. Number of respiratory and non-respiratory hospitalizations [ Time Frame: 1 year ]
  4. Decrease in walking distance at the 6 minute walking test [ Time Frame: 1 year ]
  5. Change in St. George Respiratory Questionnaire symptom scores [ Time Frame: 1 year ]
  6. Reduction in diffusion capacity (DLCO) or forced vital capacity (FVC) [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Diagnostic delays [ Time Frame: 1 year ]
    Diagnostic delay subdivided into patient related delays and health care related delays.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All incident patients with IPF at Gentofte hospital and Aarhus university hospital.
Criteria

Inclusion Criteria:

  • Diagnosis of IPF according to international guidelines

Exclusion Criteria:

  • Unable to provide written informed consent
  • Radiologic, histologic, or clinical findings inconsistent with a diagnosis of IPF

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772549


Contacts
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Contact: Nils Hoyer, MD +4538674200 nils.hoyer@regionh.dk

Locations
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Denmark
Gentofte Hospital Recruiting
Hellerup, Copenhagen, Denmark, 2800
Contact: Nils Hoyer, MD    +45-38674200    nils.hoyer@regionh.dk   
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Thomas Prio, MD       thomas.prior@auh.rm.dk   
Sponsors and Collaborators
Nils Hoyer
Aarhus University Hospital
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nils Hoyer, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02772549    
Other Study ID Numbers: DELAY
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nils Hoyer, University Hospital, Gentofte, Copenhagen:
Diagnosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial