Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
Condition: Acute Exacerbation; Idiopathic Pulmonary Fibrosis; Home Spirometry
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a chronic disease, leading to poor lung function with
      a median survival of 2-3 years. Acute exacerbation of idiopathic IPF is a complication
      associated with a mortality rate > 50%. So far, the appearance of an acute exacerbation is
      unpredictable. Worsening of the IPF accompanies with a decrease of the FVC-value, the lung
      capacity. So far, studies are missing investigating the correlation between a decrease of the
      FVC-value and emerging acute exacerbations. Therefore, this study uses daily home spirometry
      to investigate that correlation. With this study the investigators hope to determine acute
      exacerbations early and treat patients early.
    

Detailed description: 
      This study is a multi-Center study happening on five different sites, Heidelberg, Gießen,
      Grosshansdorf, München, and Hannover, all in Germany. Each site recuits ten patients for a
      total of 50 patients.

      All patients will receive a tablet and a spirometer for daily home spirometry. Each patient
      is supposed to do the home spirometry at the same time every morning. The spirometer and the
      tablet are connected via Bluetooth and data will be transferred to a webpage after the
      measurement, that team members have access to the data and can see the progress daily. Alerts
      will be automatically send to team members, if the FVC-value decreases about 5% or more
      within three consecutive days or if the patient does not do the measurement on three
      consecutive days. Study period is one year.

      In addition to the home spirometry, patients will conduct a survey to measure health related
      quality of life (K-BILD). This questionnaire will be conducted at baseline and then every 12
      weeks. Every 4 weeks the patients are participating in a phone interview to record changes in
      medication and condition. At baseline and after 3, 6, 9, and 12 months, patients will conduct
      a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and
      sputum, nasal swab, and a urine sample will be collected and analyzed.

      Aim is to detect and treat an acute exacerbation early.
    

Intervention name(s): Home spirometry
Intervention type(s): Other
Intervention description(s): Patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth. Data will be transferred to a webpage, which team members have access to. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year. Patients will also conduct a survey to measure health related quality of life (K-BILD). This questionnaire, as well as a phone interview to record changes in medication and condition will be conducted at baseline and every 4 weeks. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and urine samples will be collected and analyzed.
Intervention model: Single Group Assignment
Intervention model description: Intervention group on 5 different sites without a control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acute Exacerbation; Idiopathic Pulmonary Fibrosis; Home Spirometry