Pulmonary Fibrosis Learning and Self-Management Program (FILIP) for patients in rehab and outpatient care
Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study
This study will try a blended digital education and self-management program for adults with fibrotic interstitial lung disease during pulmonary rehabilitation and outpatient ILD care to see if patients find it acceptable, practical, and linked to changes in health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Bern and 1 other locations) |
| Trial ID | NCT07457463 on ClinicalTrials.gov |
What this trial studies
This multicenter, before-after observational cohort study implements a blended digital education and self-management program combining web-based e-learning modules with opportunities to discuss content with clinicians during routine inpatient pulmonary rehabilitation or outpatient ILD visits. A feasibility cohort receiving the program is compared to a historical control cohort treated before implementation, and an embedded feasibility sub-study examines recruitment, retention, and data collection processes. Outcomes include measures of acceptability, usability, and selected health-related outcomes collected before and after program use. The study focuses on adults with fibrotic interstitial lung disease treated at participating centers in Bern, Switzerland.
Who should consider this trial
Good fit: Adults (≥18 years) with fibrotic interstitial lung disease who are able to consent, speak German, and are receiving inpatient pulmonary rehabilitation or outpatient ILD care at the participating centers are ideal candidates.
Not a fit: Patients with cognitive impairment, insufficient German language skills, sarcoidosis (which is excluded), or those not treated at the participating centers are unlikely to benefit from participating in this program.
Why it matters
Potential benefit: If successful, the program could improve patients' disease knowledge, self-management skills, symptom coping, and overall quality of life.
How similar studies have performed: Similar digital and blended self-management programs have shown benefits in other chronic respiratory diseases like COPD, but evidence specifically in fibrotic ILD is limited and this approach remains relatively novel for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria are: * Diagnosis of a FILD as major indication for pulmonary rehabilitation (for Berner Reha Zentrum only) * Enrolled in Idiopathic interstitial Pneumonia (IIP) cohort study (Nr. 246/15 / PB\_2016-01524) and agreed to further use of data for further research purpose (for Inselspital only) * Age ≥ 18 years * Written informed consent Exclusion criteria are: * Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures * Sarcoidosis
Where this trial is running
Bern and 1 other locations
- Department for Pulmonary Medicine, Allergology and Clinical Immunology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland — Bern, Switzerland (Not_yet_recruiting)
- Center for Rehabilitation & Sports Medicine Inselspital and Berner Reha Zentrum, Bern University Hospital, University of Bern, Switzerland — Heiligenschwendi, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thimo Marcin, PHD — Center for Rehabilitation & Sports Medicine Inselspital and Berner Reha Zentrum, Bern University Hospital, University of Bern, Switzerland
- Study coordinator: Thimo Marcin, PhD
- Email: thimo.marcin@rehabern.ch
- Phone: +41 33 244 3048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.