Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay
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| ClinicalTrials.gov Identifier: NCT02772549 |
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Recruitment Status :
Recruiting
First Posted : May 13, 2016
Last Update Posted : March 5, 2020
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| Condition or disease |
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| Idiopathic Pulmonary Fibrosis |
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.
| 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 |
- 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 [ 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 |
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
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
| Contact: Nils Hoyer, MD | +4538674200 | nils.hoyer@regionh.dk |
| 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 | |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Diagnosis |
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |