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Trial record 70 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up

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ClinicalTrials.gov Identifier: NCT02818712
Recruitment Status : Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : April 15, 2019
Sponsor:
Collaborators:
Copenhagen University Hospital, Gentofte
Odense University Hospital
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

Brief Summary:
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL and disease progression has only been studied sparsely. Also, the association between biomarkers and disease progression need to be examined further.

Condition or disease
Idiopathic Pulmonary Fibrosis

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up
Actual Study Start Date : August 2016
Estimated Primary Completion Date : March 2021
Study Completion Date : March 2021


Group/Cohort
Patients with IPF



Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Change in St. George's Respiratory Questionnaire

  2. Health-related quality of life [ Time Frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months ]
    Change in St. George's Respiratory Questionnaire, IPF-specific

  3. Health-related quality of life [ Time Frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months ]
    Changes in King's Brief Interstitial Lung Disease questionnaire

  4. Number and type of comorbidities [ Time Frame: Baseline ]
    Prevalence of comorbidities at baseline

  5. Number and type of comorbidities [ Time Frame: Change/incidence at 6 months, 12 months, 24 months and 36 months ]
    Incidence of new comorbidities after 6 months, 12 months, 24 months and 36 months


Secondary Outcome Measures :
  1. Lung function tests [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Change in forced vital capacity

  2. Lung function tests [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Change in diffusion capacity for carbon monoxide

  3. 6-minute walk test [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Change in 6-minute walk test

  4. Progression in serum/plasma biomarker levels [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Increase or decrease in serum/plasma biomarker levels

  5. Health-related quality of life [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Change in Short Form 36

  6. Health-related quality of life [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Changes in University of California San Diego Shortness Of Breath Questionnaire

  7. Disease progression [ Time Frame: Baseline, 12 months, 24 months, 36 months ]
    Change in interstitial changes on high resolution CT-scan (HRCT)

  8. Disease progression [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Changes in number of acute exacerbations

  9. Disease progression [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months ]
    Changes in use of supplementary oxygen


Biospecimen Retention:   Samples With DNA
Serum and EDTA-plasma is collected from all patients at 0, 6, 12, 24 and 36 months


Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Incident and prevalent patients with IPF in Denmark.
Criteria

Inclusion Criteria:

  1. A clinical diagnosis of IPF
  2. Signed informed consent

Exclusion Criteria:

  1. Clinical, radiological or histological findings inconsistent with a diagnosis of IPF
  2. Inability or unwillingness to adhere to the study
  3. Active on lung transplantation list

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): NCT02818712


Locations
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Denmark
Aarhus University Hosptial
Aarhus C, Denmark
Gentofte Hospital
Hellerup, Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Aarhus University Hospital
Copenhagen University Hospital, Gentofte
Odense University Hospital

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Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02818712     History of Changes
Other Study ID Numbers: IPF: HRQL, comorb and biomark
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial