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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06027333
Other study ID # BernerRehaZentrum
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2023
Est. completion date August 30, 2024

Study information

Verified date March 2024
Source Berner Reha Zentrum AG
Contact Thimo Marcin, PhD
Phone +41 33 244 30 48
Email t.marcin@rehabern.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
inpatient rehabilitation
This is an uncontrolled observational study on patients undergoing usual care in pulmonary rehabilitation and care

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Berner Reha Zentrum AG Insel Gruppe AG, University Hospital Bern, University of Zurich, Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

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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