An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology

Study Purpose

The I-FILE study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. The aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Newly diagnosed patients with F-ILD according to the ATS/ERS criteria by a multidisciplinary ILD team : - MDT diagnosis ≤ 6 months before inclusion - Treatment for F-ILD ≤ than 1 month

Exclusion Criteria:

- Not able to speak, read or write in the native language of the country where the patient is included - Not able to comply to the study protocol, according to the judgement of the investigator and/or patient - No access to internet

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04304898
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Erasmus Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marlies Wijsenbeek, MD PhDWim Wuyts, MD PhDAnna-Maria Hoffmann-Vold, MD PhD
Principal Investigator Affiliation Erasmus MCUniversitair Ziekenhuis LeuvenOslo University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis
Additional Details

Nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic Interstitial lung diseases (F-ILDs). eHealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. The main aim of the I-FILE study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with F-ILD. The secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients. In total 500 patients with newly diagnosed F-ILD will be included. Patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. In addition, patient-reported outcomes (PROMs) will be completed online every 6 months. Results are encrypted and directly sent to a secured server through the online I-FILE application.

Arms & Interventions

Arms

: Single Group Assignment

Intervention group without a control group

Interventions

Other: - Home spirometry

Patients will perform daily home spirometry for three months with a Bluetooth-enabled validated, CE-marked home spirometer (Spiro bank Smart, MIR, Italy). Subsequently, patients will perform weekly home spirometry for two years in total. During this period, patients will be asked to perform three measurements each week on the same day. Hospital-based spirometry will be performed according to international guidelines. Patients will complete patient-reported outcomes (PROMs) online in the secured application every six months.

Contact a Trial Team

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International Sites

Erasmus MC, Rotterdam, Zuid-Holland, Netherlands

Status

Address

Erasmus MC

Rotterdam, Zuid-Holland, 3015 CE

Erasmus MC, Rotterdam, Netherlands

Status

Address

Erasmus MC

Rotterdam, ,

Site Contact

M.S. Wijsenbeek, dr

m.wijsenbeek-lourens@erasmusmc.nl

+31107030323

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