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

NCT07457463 | Recruiting

• 1 other identifier: 2023-01318
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lung Fibrosis Interstitial

Keywords

self-management; patient education; self-efficacy; blended learning; lung fibrosis; ILD; digital patient information

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Study feasibility outcomes - Recruitment success

  3-6 months

• Study feasibility outcomes - Retention

  3-6 months

• Study feasibility outcomes - Data collection:

  3-6 months

• Health related outcomes - self efficacy

  3- 6 months follow-up

• Health related outcomes - HRQoL

  3- 6 months follow-up

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Blended patient education and self-management programme BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
• Sarcoidosis

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Zurich: collaborator
• ZHAW School of Health Professions, Institute of Physiotherapy: collaborator

Study Sites (2)

Department for Pulmonary Medicine, Allergology and Clinical Immunology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

NOT YET RECRUITING

Center for Rehabilitation & Sports Medicine Inselspital and Berner Reha Zentrum, Bern University Hospital, University of Bern, Switzerland

Heiligenschwendi, 3625, Switzerland

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thimo Marcin, PhD

CONTACT

+41 33 244 3048; thimo.marcin@rehabern.ch

Thomas Franz Riegler, PhD

CONTACT

+41 (0) 58 934 64 06; thomas.riegler@zhaw.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a single-group, before-after observational design. All participants enrolled after implementation who consent to participate are offered access to the same digital education and self-management program. There is no randomization and no prospective assignment of participants to different interventions. Outcomes are assessed over time within the same group and compared with data from a historical cohort of patients treated prior to implementation of the program.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: March 9, 2026
• Study Start: October 7, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)