Treatable Traits in Interstitial Lung Disease
ConditionInterstitial Lung Diseases (ILD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Western Australia
About this trial
The goal of this clinical trial is to learn if a personalised treatment model of care "treatable traits" can improve quality of life and disease progression in patients with interstitial lung disease.
The main question it aims to answer is, will providing a treatable traits model of care improve health-related quality of life (HRQoL) (primary outcome), symptoms, anxiety, physical activity, and body composition (secondary outcomes).
Researchers will compare the treatable traits model to standard of care.
Participants in both arms will complete surveys, a Dual-Energy X-Ray Absorptiometry (DEXA) and whole-body composition scan, lung function and blood tests. Those in the intervention (TT) arm will be seen in a multidisciplinary clinic where they are seen by an ILD doctor, physiotherapist, psychologist, and dietitian.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Treatable traits model of care
Other interventionEmbedded multidisciplinary clinic with treatable traits model of care.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Treatable Traits model of careExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Health-related quality of life
Kings brief interstitial lung disease score that has been validated in quality of life for ILD patients.
Time frame
from enrolment to 6 months post intervention.Secondary outcomes
1
Progression free survival
the time to disease progression or death from any cause.
Time frame
from enrolment to 12 months post intervention (14 months post enrolment)2
Exercise capacity
6 minute walk test assessment
Time frame
from enrolment to 12 months post intervention (14 months post enrolment)Other outcomes
1
Economic evaluation
* A comparison of per person direct (health system and all patient expenses) and indirect (lost productivity) costs will be performed for the treatable trait program versus standard care. * Direct costs will include: staff time; visits to the GP, specialist or emergency room; hospitalisation; and use of chronic disease services including pulmonary rehabilitation, nursing and allied health services. * Patient expenses include transportation and parking costs, co-payments for medications and consultations, and costs of equipment and household adaptations
Time frame
from enrolment to 12 months post intervention (14 months post enrolment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Western Australia
Lead sponsor
Fiona Stanley Hospital
Collaborator
Sir Charles Gairdner Hospital
Collaborator
Source ClinicalTrials.gov