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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Interstitial Lung Disease; Self Efficacy; Self-management; Patient Education; Fibrotic Lung Disease
• Intervention / Treatment: Other: Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel); Behavioral: Blended patient education and self-management programme (PESM)

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).

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Thimo Marcin, PhD; Phone Number: +41 33 244 30 48; Email: t.marcin@rehabern.ch
• Study Contact Backup: Name: Thomas Riegler, Msc; Email: riel@zhaw.ch

Study Locations

• Switzerland
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Recruiting
      • Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern
      • Contact: Sabina Guler, PD MD
  • Heiligenschwendi
    • Bern, Heiligenschwendi, Switzerland, 3365
      • Recruiting
      • Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne
      • Contact: Thimo Marcin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with fibrotic lung disease participating in an inpatient rehabilitation or in outpatient consultations for interstitial lung disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Group; Patients that were included during the observational phase before implementation of the blended patient education and self-management (PESM) programme or patients that refused to participate in the PESM programme after implementation. Patients receive the usual care clinical routine programme	Other: Inpatient 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.; Other Names: outpatient consultations for interstitial lung disease
Self-management Group; Patients that were included in the study after the implementation of the blended patient education and self-management (PESM) programme and acceppted to participate in the PESM programme	Other: Inpatient 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.; Other Names: outpatient consultations for interstitial lung disease; Behavioral: Blended 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-efficacy	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool	From t0 to t2 (60-120 days after t0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-efficacy	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool	From t0 to t1 (14-40 days after t0)
Change in health related quality of life	King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Change in functional status	King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Change in self-reported symptoms	Leicester Cough Questionnaire	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Supplemental oxygen needs for activity and at rest	routinely collected data	t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
Re-hospitalization and survival	routinely collected data	from t0 to t2 (60-120 days after t0)
Change in self-reported health status	EQ-VAS Score [0 -100] (worst to best health status)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Change in self-reported anxiety and depression	Hospital Anxiety and Depression Scale [0-21] (high number indicates high symptoms)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Symptom Visual Analog Scales	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)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention acceptability	Acceptability of the PESM intervention assessed using the Acceptability of Intervention Measure (AIM).	At completion of the PESM intervention at t2 (60-120 days after t0)
Intervention appropriateness	Appropriateness of the PESM intervention assessed using the Intervention Appropriateness Measure (IAM)	At completion of the PESM intervention at t2 (60-120 days after t0)
Intervention feasibility	Feasibility of the PESM intervention assessed using the Feasibility of Intervention Measure (FIM).	At completion of the PESM intervention at t2 (60-120 days after t0)
Intervention compliance	Compliance with the intervention programme, measured as percentage of attended/performed educational modules	At completion of the PESM intervention at t2 (60-120 days after t0)
Intervention barriers and facilitators	Barriers and facilitators for implementation explored via consecutive semi-structured patient and staff interviews until data saturation.	At completion of the PESM intervention at t2 (60-120 days after t0)
Retention	Percentage of recruited patients who successfully completed pre- and post-assessment.	From enrollment (t0) to post-intervention assessment at t2 (60-120 days after t0)
Data completeness	Percentage of missing data in outcome assessments	From enrollment (t0) to post-intervention assessment at t2 (60-120 days after t0)

Collaborators and Investigators

• Sponsor: Berner Reha Zentrum AG
• Collaborators: University of Zurich; Zurich University of Applied Sciences; Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; self-management; patient education; interstitial lung disease; self efficacy; fibrotic lung disease; well-beeing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: BernerRehaZentrum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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