Evaluation of the Pulmonary Fibrosis Learning and Self-management Programme (FILIP) (FILIP)

Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study

The goal of this observational study is to evaluate the feasibility and acceptability of a newly developed digital education and self-management program for people with fibrotic interstitial lung diseases (FILD) during inpatient pulmonary rehabilitation and outpatient interstitial lung disease (ILD) care. The study also explores whether participation in the program is associated with changes in health-related outcomes.

The main questions this study aims to answer are:

• Is the digital education and self-management program acceptable, useful, and practical for patients with FILD?
• Is it feasible to recruit and retain patients and to collect outcome data for a future larger effectiveness study?
• Do patients who participate in the program show differences in health-related outcomes compared with patients treated before the program was implemented?

Patients who consent to participate during the implementation phase will be offered access to the digital education and self-management program. Their outcomes will be compared with those of a historical cohort of patients who received usual care before the program was introduced.

Participants will:

• Use a web-based digital education and self-management program with multiple e-learning modules tailored to individual needs and preferences
• Access the program via smartphone, tablet, or computer during inpatient rehabilitation or outpatient care
• Discuss questions related to the program content with healthcare professionals during routine rehabilitation sessions or clinic visits
• Complete questionnaires about their experience with the program and their health-related outcomes

Study Overview

• Status: Recruiting
• Conditions: Lung Fibrosis Interstitial
• Intervention / Treatment: Behavioral: Blended patient education and self-management programme

Detailed Description

Fibrotic interstitial lung diseases (FILD) are a group of rare and chronic lung conditions that are often associated with persistent symptoms, reduced quality of life, and limitations in daily activities. People living with FILD frequently report unmet needs regarding disease-specific education and support for self-management. In particular, patients identify a lack of clear, understandable, and patient-centered educational resources as a major gap in current inpatient rehabilitation and outpatient interstitial lung disease (ILD) care.

To address this need, a blended digital education and self-management program was developed for patients with FILD. The program combines web-based e-learning modules with opportunities for discussion and clarification with healthcare professionals during routine inpatient rehabilitation or outpatient clinical care. The digital content addresses core and optional topics related to disease understanding, symptom management, and self-management strategies. Suggested modules are based on individual patient needs and preferences identified through initial questions within the digital platform, while all modules remain accessible to all users.

This study is an exploratory, multicenter, before-after observational cohort study with an embedded feasibility sub-study. Two cohorts are included: a historical control cohort consisting of patients treated before implementation of the digital program, and a feasibility cohort consisting of patients treated after implementation who consent to participate and receive access to the digital education and self-management program. Participants are not randomized, and investigators do not assign patients to intervention or control groups. Exposure to the program is determined by timing of implementation and patient consent.

The primary objective of the feasibility sub-study is to assess intervention feasibility, including acceptability, perceived usefulness, patient satisfaction, and adherence to the digital program. Adherence is assessed by documenting participation in and completion of the educational modules. Semi-structured interviews with patients and healthcare professionals are conducted to explore barriers and facilitators to implementation in inpatient rehabilitation and outpatient care settings.

Secondary objectives address study feasibility for a future larger effectiveness trial. These objectives include evaluating the feasibility of recruiting the targeted number of participants, retaining participants through follow-up assessments, and collecting health-related outcome data with minimal missing data.

Health-related outcomes are collected to explore patients' responsiveness to the digital education and self-management program and to inform the design of a future effectiveness trial. The primary health-related outcome is self-efficacy, assessed at multiple time points using a pulmonary rehabilitation-adapted self-efficacy measure. Secondary health-related outcomes include health-related quality of life, assessed using a disease-specific questionnaire for interstitial lung disease, as well as changes in self-efficacy at earlier follow-up time points.

Additional exploratory outcomes include functional exercise capacity derived from routinely collected clinical data, patient-reported symptoms and health status using visual analog scales, patient-reported respiratory symptoms, psychological well-being, and supplemental oxygen requirements during activity. These outcomes are collected to provide a comprehensive picture of patient experiences and to evaluate the feasibility and relevance of these measures for future studies.

The digital education and self-management program is delivered through a web-based learning management system and can be accessed via smartphone, tablet, or desktop computer. For inpatient rehabilitation patients, access is provided during the rehabilitation stay, with flexible use throughout the program and support from therapists as needed. Topics from the digital program can be discussed during routine therapy sessions, and patients retain access to the digital resources after discharge. For outpatient care patients, access is provided during an ILD clinic visit, with opportunities to discuss program content during follow-up appointments and reminders to encourage engagement.

Overall, this study aims to generate essential information on the feasibility and acceptability of implementing a digital education and self-management program for patients with FILD, while providing preliminary data on relevant health-related outcomes to support planning of a future multicenter effectiveness trial.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thimo Marcin, PhD; Phone Number: +41 33 244 3048; Email: thimo.marcin@rehabern.ch
• Study Contact Backup: Name: Thomas Franz Riegler, PhD; Phone Number: +41 (0) 58 934 64 06; Email: thomas.riegler@zhaw.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Not yet recruiting
    • Department for Pulmonary Medicine, Allergology and Clinical Immunology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
    • Contact: Sabina Guler, MD; Phone Number: +41 31 632 21 11; Email: sabina.guler@insel.ch
  • Heiligenschwendi, Switzerland, 3625
    • Recruiting
    • Center for Rehabilitation & Sports Medicine Inselspital and Berner Reha Zentrum, Bern University Hospital, University of Bern, Switzerland
    • Contact: Thimo Marcin, PhD; Phone Number: +41 33 244 3048; Email: thimo.marcin@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; This arm includes patients with fibrotic interstitial lung diseases enrolled in the observational study during the feasibility phase. Participants who consent to participate are offered access to a blended digital education and self-management program in addition to usual inpatient pulmonary rehabilitation or outpatient ILD care.

Behavioral: Blended patient education and self-management programme; The program consists of multiple web-based e-learning modules covering core and optional topics relevant to lung fibrosis. Modules are suggested based on individual symptoms and self-management needs, but all content is accessible to all users. The program can be accessed via smartphone, tablet, or computer using a web link. It is intended solely for education and well-being support and is not used for diagnosis, monitoring, treatment, or prognosis of disease. In inpatient rehabilitation, patients may use the program flexibly during their stay, with support from therapists as needed, and can discuss content during routine therapy sessions. In outpatient care, patients receive access during an ILD clinic visit and can discuss content during follow-up appointments, supported by reminders to encourage use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility outcomes - Acceptance	Acceptability of Intervention Measure (AIM): 4-item questioniare measuring the acceptability of an intervention on a 5-likert scale (completely disagree to completely agree).	3-6 months follow-up
Intervention feasibility outcomes - Appropriateness	Intervention Appropriateness Measure (IAM): 4-item questioniare measuring the appropriation of an intervention on a 5-likert scale (completely disagree to completely agree).	3-6 months follow-up
Intervention feasibility outcomes - Feasibiilty	Feasibility of Intervention Measure (FIM): 4-item questioniare measuring the acceptability of an intervention on a f-likert scale (completely disagree to completely agree).	3-6 months follow-up
Intervention feasibility outcomes - Compliance	percent of attended/performed educational modules.	3-6 months follow-up
Intervention feasibility outcomes - Farriers and facilitators	Consecutive semi-structured patient and staff interviews will be performed until data saturation to explore barriers and facilitators for implementation.	3-6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study feasibility outcomes - Recruitment success	Recruitment success: Time to assess the targeted the 50 patients for the feasibility study.	3-6 months
Study feasibility outcomes - Retention	Number of recruited patients that successfully completed the study (pre- and post-assessment)	3-6 months
Study feasibility outcomes - Data collection:	Percentage of missing data in outcome assessments.	3-6 months
Health related outcomes - self efficacy	Change in self-efficacy from t0 to t1 and t2, assessed with the Pulmonary Rehabilitation Adapted Index of Self-Efficacy	3- 6 months follow-up
Health related outcomes - HRQoL	Change in HRQOL from t0 to t1 and t2 assessed by the King's Brief Interstitial Lung Disease health status questionnaire	3- 6 months follow-up
Health related outcomes - functional status	functional status assessed by six-minute walking test (routinely collected data)	from start to end of inpatient rehabilitation
Health related outcomes - self-reported health status (VAS)		3- 6 months follow-up
Health related outcomes - Anxiety and Depression Score	Self-reported anxiety and depression (Hospital Anxiety and Depression Scale)	3- 6 months follow-up
Health related outcomes - oxygen supplementation	Supplemental oxygen needs for activity and at rest (routinely collected data)	3- 6 months follow-up
Health related outcomes - Re-hospitalization	re-hospitalization (y/n)	3- 6 months follow-up
Health related outcomes - survival	survival (y/n)	3- 6 months follow-up

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Zurich; ZHAW School of Health Professions, Institute of Physiotherapy
• Investigators: Principal Investigator: Thimo Marcin, PHD, Center for Rehabilitation & Sports Medicine Inselspital and Berner Reha Zentrum, Bern University Hospital, University of Bern, Switzerland; Principal Investigator: Sabina Guler, MD, Department for Pulmonary Medicine, Allergology and Clinical Immunology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: self-management; patient education; self-efficacy; ILD; lung fibrosis; blended learning; digital patient information
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis
• Other Study ID Numbers: 2023-01318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data for patients who signed the additional informed consent for further use of data may be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No