Clinical trial NCT06027333: Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease
Official title: Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Berner Reha Zentrum AG
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Zurich University of Applied Sciences
name: University of Zurich
First posted: 2023-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-efficacy
timeFrame: From t0 to t2 (60-120 days after t0)
Secondary outcomes:
measure: Change in Self-efficacy
timeFrame: From t0 to t1 (14-40 days after t0)
measure: Change in health related quality of life
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Change in functional status
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Change in self-reported health status
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Change in self-reported symptoms
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Change in self-reported anxiety and depression
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Symptom Visual Analog Scales
timeFrame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
measure: Supplemental oxygen needs for activity and at rest
timeFrame: t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
measure: Re-hospitalization and survival
timeFrame: from t0 to t2 (60-120 days after t0)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne
state: Heiligenschwendi
city: Bern
country: Switzerland
facility: Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern
Study officials:
References: