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CompletedNCT02818712Updated Oct 6, 2021

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

An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Aarhus University Hospital. Completed at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Aarhus University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Idiopathic Pulmonary Fibrosis
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In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 150 is above the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Incident and prevalent patients with IPF in Denmark.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with IPF
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What researchers measure

Primary outcomes

  1. Health-related quality of life

    Change in St. George's Respiratory Questionnaire

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  2. Health-related quality of life

    Change in St. George's Respiratory Questionnaire, IPF-specific

    Time frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

  3. Health-related quality of life

    Changes in King's Brief Interstitial Lung Disease questionnaire

    Time frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

  4. Number and type of comorbidities

    Prevalence of comorbidities at baseline

    Time frame: Baseline

  5. Number and type of comorbidities

    Incidence of new comorbidities after 6 months, 12 months, 24 months and 36 months

    Time frame: Change/incidence at 6 months, 12 months, 24 months and 36 months

Secondary outcomes

  1. Lung function tests

    Change in forced vital capacity

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  2. Lung function tests

    Change in diffusion capacity for carbon monoxide

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  3. 6-minute walk test

    Change in 6-minute walk test

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  4. Progression in serum/plasma biomarker levels

    Increase or decrease in serum/plasma biomarker levels

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  5. Health-related quality of life

    Change in Short Form 36

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  6. Health-related quality of life

    Changes in University of California San Diego Shortness Of Breath Questionnaire

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  7. Disease progression

    Change in interstitial changes on high resolution CT-scan (HRCT)

    Time frame: Baseline, 12 months, 24 months, 36 months

  8. Disease progression

    Changes in number of acute exacerbations

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

  9. Disease progression

    Changes in use of supplementary oxygen

    Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

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Study locations

3 sites
  • Aarhus University Hosptial
    Aarhus C, Denmark
  • Gentofte Hospital
    Hellerup, Denmark
  • Odense University Hospital
    Odense, Denmark
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References and documents

Publications

  • Prior TS, Hoyer N, Hilberg O, Shaker SB, Davidsen JR, Bendstrup E. Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis. Respir Res. 2020 Apr 21;21(1):91. doi: 10.1186/s12931-020-01359-3. PubMed 32316976 ↗
  • Prior TS, Hilberg O, Shaker SB, Davidsen JR, Hoyer N, Birring SS, Bendstrup E. Validation of the King's Brief Interstitial Lung Disease questionnaire in Idiopathic Pulmonary Fibrosis. BMC Pulm Med. 2019 Dec 19;19(1):255. doi: 10.1186/s12890-019-1018-0. PubMed 31856786 ↗
  • Prior TS, Hoyer N, Shaker SB, Davidsen JR, Yorke J, Hilberg O, Bendstrup E. Validation of the IPF-specific version of St. George's Respiratory Questionnaire. Respir Res. 2019 Aug 28;20(1):199. doi: 10.1186/s12931-019-1169-9. PubMed 31462235 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02818712
Lead sponsor
Aarhus University Hospital
Collaborators
Copenhagen University Hospital, Gentofte, Odense University Hospital
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Aug 2016
Primary completion
Jun 2021
Completion
Jun 2021
Last update
Oct 6, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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