An interventional study of Treatable traits model of care in Interstitial Lung Diseases (ILD), sponsored by The University of Western Australia. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by The University of Western Australia · Not applicable, Interventional, and Treatment
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.
RCT to compare treatable traits (TT) model of care to standard practice. Primary endpoints reviewed will be health-related QOL as defined by the validated King's Brief Interstitial Lung Disease (KB-ILD) questionnaire. Secondary endpoints will include progression free survival (the time to disease progression or death from any cause), all-cause hospitalisation and mortality, and economic evaluation (comparison of per person direct and indirect costs intervention vs standard of care).
Patients included will be those over 18yo with an interstitial lung disease across hospitals in Western Australia. Target study number will be 55 per arm. Participants will be randomised via an online randomisation system (REDCAP) in a 1:1 fashion to standard or care of the TT MDT clinic. Randomisation will be stratified with a 50% IPF limit and according to severity (mild, moderate and severe from FVC). Participants and clinicians will not be blinded to group allocation. Statistician will be blinded for data analysis.
The embedded clinic will involve multidimensional assessment of patients. At the clinic, the patient will be assessed by a nurse, physiotherapist, psychologist, dietician, and physician. At the end of the clinic the team will meet to discuss each patient and devise a plan to optimise the management of TTs for that individual.
Multidimensional assessment will include demographics, co-morbidities, medications, exposures, blood results, prior investigations, and MDT diagnosis. Questionnaires completed at time of enrolment include KB-ILD (assess QOL), SF26 QOL), Leister Cough questionnaire (Cough), Stop-bang (OSA), mMRC (SOB), fatigue severity score (Fatigue), PGSGASF (nutritional status), perceived stress score (anxiety), GAD score (anxiety), PHQ9 (depression).
Other assessments include lung function, blood testing, sputum assessment, HRCT. Physiotherapy assessments will include 1 minute STS, 6MWT, DEXA scan. Nutritional assessment will be based on BMI and PG-SGA scores.
Interventions provided include standard of care medications (anti-fibrotic and immunosuppressive therapies as per guidelines). Specific physiotherapy intervention will be pulmonary rehabilitation; dietician input will involve dietary counselling and consideration of oral nutritional supplements. Psychology intervention will be self-management strategies or referral to individual psychology.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →The University of Western Australia is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients with a new or pre-existing diagnosis of fibrotic ILD who receive care via the Fiona Stanley Hospital (FSH) or Sir Charles Gairdner Hospital (SCGH) ILD service will be invited to participate. This ILD diagnosis must be made through an ILD MDT.
Included participants will be aged ≥ 18 years with a physician-confirmed diagnosis of fibrotic ILD. Fibrotic ILD is defined as presence of fibrotic changes on CT in the opinion of the investigator. All ILD subtypes, excluding sarcoidosis, will be included. Participants will need to be able to provide consent to participate and be established on stable ILD treatment for 1 month prior to study initiation.
Exclusion Criteria: Participants will be excluded if they have experienced an acute exacerbation 4 weeks prior to starting the study or are expected to experience either a transplant or death during the study period. Active suicidality, severe depression, active psychosis or mania, or other severe psychiatric concerns that require more intensive treatment. Any such participants could be referred for individual therapy and/or psychiatric treatment that would be more appropriate for their needs.
Embedded multidisciplinary clinic. This involves multidimensional assessment of patients with MDT review to determine presence of treatable traits and their specific management.
Other: Treatable traits model of care
Standard of care where physician-led ILD clinic. All referrals and comorbidity management as guided by physician.
Embedded multidisciplinary clinic with treatable traits model of care.
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.
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)
Exercise capacity
6 minute walk test assessment
Time frame: from enrolment to 12 months post intervention (14 months post enrolment)
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)
PDFs hosted by the registry, ClinicalTrials.gov.
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The University of Western Australia