Personalised treatable-traits care for people with interstitial lung disease
Treatable Traits in Interstitial Lung Disease
This project tests whether a personalised 'treatable traits' care model can improve quality of life and slow disease progression for adults with fibrotic interstitial lung disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Western Australia Academic / other |
| Locations | 2 sites (Perth, Western Australia and 1 other locations) |
| Trial ID | NCT06626438 on ClinicalTrials.gov |
What this trial studies
This randomised controlled trial will compare a personalised 'treatable traits' multidisciplinary care model to usual care for adults with fibrotic ILD at two hospitals in Perth, Western Australia. Participants will be randomised 1:1 and complete surveys, lung function and blood tests, and DEXA whole-body composition scans, with follow-up for progression, hospitalisations, and mortality. The intervention arm attends an embedded multidisciplinary clinic where an ILD physician, physiotherapist, psychologist, dietitian and nurse meet to create an individualised plan targeting identified treatable traits. The primary outcome is health-related quality of life measured by the King's Brief Interstitial Lung Disease questionnaire, with secondary endpoints including progression-free survival, healthcare use, mortality and an economic evaluation.
Who should consider this trial
Good fit: Adults (≥18) with a physician-confirmed diagnosis of fibrotic ILD (excluding sarcoidosis), diagnosed by an ILD MDT, who receive care via Fiona Stanley Hospital or Sir Charles Gairdner Hospital and are on stable ILD treatment for at least one month.
Not a fit: Patients who have had an acute exacerbation within four weeks, those expected to undergo transplant or die during the study period, or those with severe active psychiatric illness are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could improve patients' quality of life and symptom control and may slow disease progression and reduce hospital admissions through personalised multidisciplinary care.
How similar studies have performed: The treatable-traits model has shown promise in chronic airway diseases such as COPD and asthma but is largely untested in fibrotic ILD, so this is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Perth, Western Australia and 1 other locations
- Sir Charles Gairdner Hospital — Perth, Western Australia, Australia (Not_yet_recruiting)
- Fiona Stanley Hospital — Perth, Western Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Yuben Moodley, MBSS, FRACP, MD, PHD — The University of Western Australia
- Study coordinator: Megan Harrison, MBSS (Hons) FRACP
- Email: megan.harrison@health.wa.gov.au
- Phone: +61 08 6457 3333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.