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

Sponsor

Berner Reha Zentrum AG (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06027333

Collaborator

Insel Gruppe AG, University Hospital Bern (Other), Zurich University of Applied Sciences (Other), University of Zurich (Other)

Enrollment

Locations

11.3

Anticipated Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease Fibrotic Lung Disease Self Efficacy Self-management Patient Education Quality of Life	Behavioral: inpatient rehabilitation

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Outcome Measures

Primary Outcome Measures

Change in Self-efficacy [From t0 to t2 (60-120 days after t0)]
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool

Secondary Outcome Measures

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion criteria are:

1a. For Berner Reha Zentrum only: Diagnosis of a FILD as major indication for pulmonary rehabilitation

1b. 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 2. Age ≥ 18 years 3. Written informed consent

Exclusion criteria are:

Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
Sarcoidosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne	Bern	Heiligenschwendi	Switzerland	3365
2	Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern	Bern		Switzerland	3010