Quality of Life Clinical Trial
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).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne | Bern | Heiligenschwendi |
Switzerland | Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Berner Reha Zentrum AG | Insel Gruppe AG, University Hospital Bern, University of Zurich, Zurich University of Applied Sciences |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Self-efficacy | Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool | From t0 to t2 (60-120 days after t0) | |
Secondary | Change in Self-efficacy | Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool | From t0 to t1 (14-40 days after t0) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Re-hospitalization and survival | routinely collected data | from t0 to t2 (60-120 days after t0) |
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