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NCT Number: NCT06027333

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

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).

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Key information

Conditions

Interstitial Lung Disease Fibrotic Lung Disease Lung Diseases Lung Diseases, Interstitial Patient Education Quality of Life Respiratory Tract Diseases Self Efficacy Self-management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Canton of Bern, Switzerland

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About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel)

Other

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

Blended patient education and self-management programme (PESM)

Behavioral

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.

Primary outcomes

  1. Change in Self-efficacy

    Time frame: From t0 to t2 (60-120 days after t0)

    Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool

Secondary outcomes

  1. Change in Self-efficacy

    Time frame: From t0 to t1 (14-40 days after t0)

    Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool

  2. Change in health related quality of life

    Time frame: 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,

  3. Change in functional status

    Time frame: 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,

  4. Change in self-reported health status

    Time frame: 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)

  5. Change in self-reported symptoms

    Time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)

    Leicester Cough Questionnaire

  6. Change in self-reported anxiety and depression

    Time frame: 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)

  7. Symptom Visual Analog Scales

    Time frame: 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)

  8. Supplemental oxygen needs for activity and at rest

    Time frame: t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)

    routinely collected data

  9. Re-hospitalization and survival

    Time frame: from t0 to t2 (60-120 days after t0)

    routinely collected data

Other outcomes

  1. Intervention acceptability

    Time frame: At completion of the PESM intervention at t2 (60-120 days after t0)

    Acceptability of the PESM intervention assessed using the Acceptability of Intervention Measure (AIM).

  2. Intervention appropriateness

    Time frame: At completion of the PESM intervention at t2 (60-120 days after t0)

    Appropriateness of the PESM intervention assessed using the Intervention Appropriateness Measure (IAM)

  3. Intervention feasibility

    Time frame: At completion of the PESM intervention at t2 (60-120 days after t0)

    Feasibility of the PESM intervention assessed using the Feasibility of Intervention Measure (FIM).

  4. Intervention compliance

    Time frame: At completion of the PESM intervention at t2 (60-120 days after t0)

    Compliance with the intervention programme, measured as percentage of attended/performed educational modules

  5. Intervention barriers and facilitators

    Time frame: At completion of the PESM intervention at t2 (60-120 days after t0)

    Barriers and facilitators for implementation explored via consecutive semi-structured patient and staff interviews until data saturation.

  6. Retention

    Time frame: From enrollment (t0) to post-intervention assessment at t2 (60-120 days after t0)

    Percentage of recruited patients who successfully completed pre- and post-assessment.

  7. Data completeness

    Time frame: From enrollment (t0) to post-intervention assessment at t2 (60-120 days after t0)

    Percentage of missing data in outcome assessments

Study contacts

Contact information is provided by the study sponsor or research team.

Thimo Marcin, PhD

CONTACT

[email protected]

+41 33 244 30 48

Thomas Riegler, Msc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Berner Reha Zentrum AG

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • University of Zurich
  • Zurich University of Applied Sciences

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 7, 2023
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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