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: Behavioral: inpatient rehabilitation

• 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
  • 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?

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)

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, 2024
• Study Completion (Estimated): August 30, 2024

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): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

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