Personalised treatable-traits care for people with interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fiona Stanley Hospital
  Perth, Western Australia, Australia Recruiting
• Sir Charles Gairdner Hospital
  Perth, Western Australia, Australia Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.