NCT06027333

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

August 31, 2023

Last Update Submit

March 12, 2024

Conditions

Interstitial Lung DiseaseFibrotic Lung DiseaseSelf EfficacySelf-managementPatient EducationQuality of Life

Keywords

self efficacyself-managementpatient educationwell-beeingquality of lifefibrotic lung diseaseinterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Change in Self-efficacy

    Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool

    From t0 to t2 (60-120 days after t0)

Secondary Outcomes (9)

  • Change in Self-efficacy

    From t0 to t1 (14-40 days after t0)

  • 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)

  • Change in functional status

    From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)

  • 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)

  • Change in self-reported symptoms

    From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)

  • +4 more secondary outcomes

Interventions

inpatient rehabilitationBEHAVIORAL

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

Also known as: outpatient consultations for interstitial lung disease

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with fibrotic lung disease participating in an inpatient rehabilitation or in outpatient consultations for interstitial lung disease

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne

Bern, Heiligenschwendi, 3365, Switzerland

RECRUITING

Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Thimo Marcin, PhD

CONTACT

+41 33 244 30 48t.marcin@rehabern.ch

Thomas Riegler, Msc

CONTACT

riel@zhaw.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

November 8, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

CH(2)