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Completed

NCT Number: NCT02818712

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hosptial, Aarhus C, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical diagnosis of IPF
  • Signed informed consent

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Odense University Hospital
  • University Hospital, Gentofte, Copenhagen

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2016
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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