Fibrotic Lung Disease, Interstitial Lung Disease, Patient Education, Quality of Life, Self Efficacy, Self-management
Conditions
Keywords
self efficacy, self-management, patient education, well-beeing, quality of life, fibrotic lung disease, interstitial lung disease
Brief summary
Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient rehabilitation or in outpatient pulmonary care will be invited to participate in this observational study. Patients will fill out questionnaire regarding quality of life and symptoms at baseline and follow-up (at the end of rehabilitation or after the second outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for the IIP registry will be used for this project. The aim is to assess changes in self-efficacy and quality of life over time and to establish a control cohort for a later feasibility study on a educational and self-management intervention (currently in planning).
Detailed description
This exploratory, uncontrolled, before-and-after, multicentre observational study investigated self-efficacy and health-related quality of life in patients with fibrotic interstitial lung disease (fILD) who were undergoing inpatient pulmonary rehabilitation at the Berner Reha Zentrum or outpatient ILD care at the Inselspital, University Hospital Bern. The study has two objectives: (1) to describe changes in self-efficacy and quality of life among fILD patients receiving usual care; and (2) to provide a control group for a subsequent feasibility study evaluating a newly developed digital patient education and self-management programme (PESM). The PESM programme is a blended-learning intervention combining web-based e-learning modules with face-to-face clarification of content by a physiotherapist during inpatient rehabilitation or an ILD nurse during outpatient consultations. The programme was implemented sequentially at each site at different time points: On October 2025 at the Berner Reha Zentrum (inpatient) and on March 2026 at the Inselspital (outpatient). Patients who enrolled prior to the implementation of the PESM programme at their respective site, or who declined to participate in the programme after its implementation, are included in the Observational Group (usual care only). Patients who enrolled after implementation and accepted participation in the PESM programme are included in the Self-management Group (usual care plus PESM). Outcomes are assessed at baseline (t0) and at follow-ups at t1 (14-40 days after t0 for the inpatient setting only) and t2 (60-120 days after t0). These assessments include self-efficacy (PRAISE), health-related quality of life (K-BILD), self-reported symptoms, anxiety and depression (HADS), functional status and routinely collected clinical data. Comparing the two cohorts (before and after PESM implementation) will provide initial insights into the programme's potential effectiveness, as well as providing feasibility outcomes regarding acceptability, appropriateness and feasibility (AIM/IAM/FIM).
Interventions
OTHERInpatient rehabilitation (BRZ) or regular outpatient consultations (Insel)
Patients recruited at the Berner Reha Zentrum recieve standard inpatient pulmonary rehabilitation programme for patients with fibrotic ILD, including supervised exercise training, education and multidisciplinary care as part of routine clinical practice. Patients recruitet at the Inselspital Bern recieve regular outpatient fILD consultations every three to six months as part of routine clinical practice.
BEHAVIORALBlended patient education and self-management programme (PESM)
The web-based digital programme consists of multiple e-learning modules covering the core and subtopics identified with the preceding Delphi study. \*\*Intervention for inpatient rehabilitation patients:\*\* Patients will be free to schedule and go through the e-learning modules during the course of the rehabilitation. During the usual care therapy sessions, patients will have the opportunity to discuss topics and questions regarding the content of the digital program face-to-face with a physiotherapist in order to clarify questions. Patients will retain access to the e-learning resources after rehabilitation for self-management support. \*\*Intervention for outpatient care:\*\* Patients will receive access to the learning platform during their initial ILD consultation and will be free to schedule and go through the e-learning modules and discuss topics and questions during their next consultation appointment with the ILD nurse.
Sponsors
Berner Reha Zentrum AG
Insel Gruppe AG, University Hospital Bern
Zurich University of Applied Sciences
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
are: * For Berner Reha Zentrum only: Diagnosis of a FILD as major indication for pulmonary rehabilitation * For Inselspital 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-efficacy | From t0 to t2 (60-120 days after t0) | Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-efficacy | From t0 to t1 (14-40 days after t0) | Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool |
| Change in health related quality of life | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire, |
| Change in functional status | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire, |
| Change in self-reported health status | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | EQ-VAS Score \[0 -100\] (worst to best health status) |
| Change in self-reported symptoms | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | Leicester Cough Questionnaire |
| Change in self-reported anxiety and depression | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | Hospital Anxiety and Depression Scale \[0-21\] (high number indicates high symptoms) |
| Symptom Visual Analog Scales | From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0) | Visual Analog Scales \[0-100\] for Cough, Dyspnoea, Fatigute, Emotions to self-report severity, impairement and self-efficacy in symptom management. (100 means high severity, high impairment and high self-efficacy) |
| Supplemental oxygen needs for activity and at rest | t0, t1 (14-40 days after t0) and t2 (60-120 days after t0) | routinely collected data |
| Re-hospitalization and survival | from t0 to t2 (60-120 days after t0) | routinely collected data |
Countries
Switzerland
Contacts
CONTACTThimo Marcin, PhD
CONTACTThomas Riegler, Msc
Outcome results
None listed