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

Recruiting

• Conditions: Fibrotic Lung Disease; Patient Education; Interstitial Lung Disease; Quality of Life; Self Efficacy; Self-management

• Registration Number: NCT06027333
• Lead Sponsor: Berner Reha Zentrum AG

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Study Start: 2023-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 \[0 -100\] (worst to best health status)
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 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
Re-hospitalization and survival	from t0 to t2 (60-120 days after t0)	routinely collected data
Change in Self-efficacy	From t0 to t1 (14-40 days after t0)	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
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 \[0-21\] (high number indicates high symptoms)
Symptom Visual Analog Scales	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)
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,
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

Trial Locations

Locations (2)

Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern; 🇨🇭 Bern, Switzerland

Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne; 🇨🇭 Bern, Heiligenschwendi, Switzerland