Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE.
Gizal Nakshbandi, Catharina C Moor, Katerina Antoniou...
https://pubmed.ncbi.nlm.nih.gov/36732734Actively Recruiting
Age: 18Years +
All Genders
ID04304898
An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE
Led by Erasmus Medical Center · Updated on 2024-03-20
700
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a patient-led registry with home monitoring for people newly diagnosed with fibrotic interstitial lung diseases (F-ILDs). The study aims to better understand disease progression to help identify patients with worsening conditions earlier. This observational study involves multiple centers across different countries and focuses on using eHealth technology to monitor lung function and quality of life. Participants will use a Bluetooth-enabled, validated home spirometer to measure lung function daily for the first three months, then weekly for a total of two years. Hospital-based spirometry will also be done following international guidelines. Every six months, participants will complete online questionnaires about their health and quality of life through a secure application. Data collected will be encrypted and sent directly to a protected server. During the study, researchers will track lung capacity changes, adherence to spirometry, quality of life, symptom changes, and patient and healthcare provider satisfaction over two years. Participants will perform regular lung function tests and complete patient-reported outcomes online. The study will also review mortality and predictors of disease progression. This long-term monitoring helps gather detailed information about disease behavior with minimal burden on patients and providers.
CONDITIONS
Brief Title
An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with fibrotic interstitial lung disease according to ATS/ERS criteria by a multidisciplinary team
- Diagnosis made within 6 months before inclusion
- Treatment for fibrotic interstitial lung disease started within one month or less
- Able to speak, read, and write in the native language of the country
- Access to the internet for study participation
You will not qualify if you...
- Unable to speak, read, or write in the native language of the country
- Unable to comply with the study protocol as judged by investigator or patient
- No access to internet for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Monitoring
Duration - 2 years
Participants perform daily home spirometry for three months followed by weekly home spirometry for up to two years to monitor lung function. Patient-reported outcomes are completed online every 6 months.
Daily home spirometry for 3 months, then weekly home spirometry; PROMs completed online every 6 months
Trial Site Locations
Total: 2 locations
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE
Actively Recruiting
2
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
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Research Team
M
Marlies Wijsenbeek, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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