Interstitial Lung Diseases (ILD)TTRILDNCT06626438
Treatable Traits in Interstitial Lung Disease
A study testing Treatable traits model of care in people with Interstitial Lung Diseases (ILD), run by The University of Western Australia at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases (ILD)
- What is being tested?
- Treatable traits model of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesAustralia
- Study dates
- 3 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Not yet recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Megan Harrison, MBBS FRACP, +6147504307, he18696@health.wa.gov.au
Lisa Bateman, BSN, +61478 279 934, scgh.ild@health.wa.gov.au
- Recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
Sharon Maxwell, Bachelor of Nursing, +61 08 6152 2222, sharon.maxwell@health.wa.gov.au
Megan Harrison, MBBS FRACP, 61475044307, megan.harrison@health.wa.gov.au
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Interstitial Lung Diseases (ILD)
- Being tested
- Treatable traits model of care
- Keywords
- treatable traits, interstitial lung disease, pulmonary fibrosis, multidisciplinary
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatable traits model of careOther
Embedded multidisciplinary clinic with treatable traits model of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Kings brief interstitial lung disease score that has been validated in quality of life for ILD patients.
Measured: from enrolment to 6 months post intervention.
Secondary outcomes (2)
Progression free survival
the time to disease progression or death from any cause.
Measured: from enrolment to 12 months post intervention (14 months post enrolment)
Exercise capacity
6 minute walk test assessment
Measured: from enrolment to 12 months post intervention (14 months post enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start3 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Fiona Stanley Hospital, Sir Charles Gairdner Hospital
- Responsible party
- Principal investigator, Megan Harrison, The University of Western Australia
- Investigators
- Yuben Moodley, MBSS, FRACP, MD, PHD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626438
- Sponsor's protocol ID
- RGS0000006668
- Other IDs
- MRFF2022914
- Acronym
- TTRILD
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatable Traits in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06626438
- Acronym / sponsor ID
- TTRILD / RGS0000006668
- Conditions
- Interstitial Lung Diseases (ILD)
- Keywords
- treatable traits, interstitial lung disease, pulmonary fibrosis, multidisciplinary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Fiona Stanley Hospital, Sir Charles Gairdner Hospital
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatable Traits model of care | Experimental | Other: Treatable traits model of careEmbedded multidisciplinary clinic. This involves multidimensional assessment of patients with MDT review to determine presence of treatable traits and their specific management. |
| Standard of Care | No intervention | –Standard of care where physician-led ILD clinic. All referrals and comorbidity management as guided by physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatable traits model of careEmbedded multidisciplinary clinic with treatable traits model of care. | Other | Treatable Traits model of care |
Primary outcome
Health-related quality of life
Time frame: from enrolment to 6 months post intervention.
Kings brief interstitial lung disease score that has been validated in quality of life for ILD patients.
2 secondary outcomes
Progression free survival
Time frame: from enrolment to 12 months post intervention (14 months post enrolment)
Exercise capacity
Time frame: from enrolment to 12 months post intervention (14 months post enrolment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuben Moodley, MBSS, FRACP, MD, PHD principal investigator
The University of Western Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatable traits model of care in people with Interstitial Lung Diseases (ILD), run by The University of Western Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Harrison, MBSS (Hons) FRACP (+61 08 6457 3333, megan.harrison@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: from enrolment to 6 months post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.