Interstitial Lung DiseaseNCT06027333
Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease
An observational study of Interstitial Lung Disease and Fibrotic Lung Disease, run by Berner Reha Zentrum AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Fibrotic Lung Disease, Self Efficacy
- What is being tested?
- Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel) and Blended patient education and self-management programme (PESM)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 8 Nov 2023to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with fibrotic lung disease participating in an inpatient rehabilitation or in outpatient consultations for interstitial lung disease
Who may be able to join
- 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
Who cannot join
- Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
- Sarcoidosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Riegler, Msc contact
Switzerland2 sites, 2 recruiting
- Recruiting
Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern
Bern, Canton of Bern, 3010
Sabina Guler, PD MD
- Recruiting
Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne
Bern, Heiligenschwendi, 3365
Thimo Marcin, PhD
About this study
Official title: 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).
Read the 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).
- Conditions
- Interstitial Lung Disease, Fibrotic Lung Disease, Self Efficacy, Self-management, Patient Education, Quality of Life
- Being tested
- Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel), Blended patient education and self-management programme (PESM)
- Keywords
- self efficacy, self-management, patient education, well-beeing, quality of life, fibrotic lung disease, interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel)Other
Also called outpatient consultations for interstitial lung disease
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.
Blended patient education and self-management programme (PESM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel) | |
| 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 Receives: Other: Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel); Behavioral: Blended patient education and self-management programme (PESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-efficacy
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
Measured: From t0 to t2 (60-120 days after t0)
Secondary outcomes (9)
Change in Self-efficacy
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
Measured: 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,
Measured: 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,
Measured: From t0 to t1 (14-40 days after t0) and 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
Re-hospitalization and survival
routinely collected data
Measured: from t0 to t2 (60-120 days after t0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start8 Nov 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berner Reha Zentrum AG
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Zurich University of Applied Sciences, University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027333
- Sponsor's protocol ID
- BernerRehaZentrum
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study
- ClinicalTrials.gov ID
- NCT06027333
- Acronym / sponsor ID
- BernerRehaZentrum
- Conditions
- Interstitial Lung Disease, Fibrotic Lung Disease, Self Efficacy, Self-management, Patient Education, Quality of Life
- Keywords
- self efficacy, self-management, patient education, well-beeing, quality of life, fibrotic lung disease, interstitial lung disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Berner Reha Zentrum AGUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Zurich University of Applied Sciences, University of Zurich
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Other: Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel)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 |
| Self-management Group | – | Other: Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel), Behavioral: Blended patient education and self-management programme (PESM)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with fibrotic lung disease participating in an inpatient rehabilitation or in outpatient consultations for interstitial lung disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
- Sarcoidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient rehabilitation (BRZ) or regular outpatient consultations (Insel)Also: outpatient consultations for interstitial lung diseasePatients 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 | Observational Group, Self-management Group |
| 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. | Behavioural | Self-management Group |
Primary outcome
Change in Self-efficacy
Time frame: From t0 to t2 (60-120 days after t0)
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
9 secondary outcomes
Change in Self-efficacy
Time frame: From t0 to t1 (14-40 days after t0)
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)
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)
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)
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)
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)
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)
Supplemental oxygen needs for activity and at rest
Time frame: t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
Re-hospitalization and survival
Time frame: from t0 to t2 (60-120 days after t0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Riegler, Msc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Fibrotic Lung Disease, run by Berner Reha Zentrum AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thimo Marcin, PhD (+41 33 244 30 48, t.marcin@rehabern.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-efficacy (time frame: From t0 to t2 (60-120 days after t0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.