Treatable Traits in Interstitial Lung Disease

NCT06626438 | Recruiting

• 2 other identifiers: RGS0000006668MRFF2022914
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Interstitial Lung Diseases (ILD)

Keywords

treatable traits; interstitial lung disease; pulmonary fibrosis; multidisciplinary

Outcome Measures

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.

  from enrolment to 6 months post intervention.

Secondary Outcomes (2)

• Progression free survival

  from enrolment to 12 months post intervention (14 months post enrolment)

• Exercise capacity

  from enrolment to 12 months post intervention (14 months post enrolment)

Other Outcomes (1)

• Economic evaluation

  from enrolment to 12 months post intervention (14 months post enrolment)

Study Arms (2)

Treatable Traits model of care

EXPERIMENTAL

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

NO INTERVENTION

Standard of care where physician-led ILD clinic. All referrals and comorbidity management as guided by physician.

Interventions

Treatable traits model of care OTHER

Embedded multidisciplinary clinic with treatable traits model of care.

Treatable Traits model of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Western Australia: lead
• Fiona Stanley Hospital: collaborator
• Sir Charles Gairdner Hospital: collaborator

Study Sites (2)

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

NOT YET RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuben Moodley, MBSS, FRACP, MD, PHD

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Harrison, MBSS (Hons) FRACP

CONTACT

+61 08 6457 3333; megan.harrison@health.wa.gov.au

Yuben Moodley, MBSS, FRACP, MD, PHD

CONTACT

61086152 2222; yuben.moodley@health.wa.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

AU (2)