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Treatable Traits in Interstitial Lung Disease
The goal of this clinical trial is to learn if a multidisciplinary clinic using a treatable traits model of care improves outcomes for patients with interstitial lung disease. This model of care involves identifying patient -specific traits (such as cough, progressive fibrosis, exercise intolerance) and targeting treatments to these. There is significant involvement by allied health members including physiotherapy, dietician, and psychology.
The main question is to assess if patients have improved quality of life with this clinic and its interventions, does it have an impact on hospitalisation, and mortality, and is there an economic difference when compared to standard of care.
Study details:
Single site 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 66 per arm. Participants will be randomised via an online randomisation system (NQuery) in a 1:1 fashion to IPF and non-IPF ILD based on the ILDs.
Participants and clinicians will not be blinded to group allocation, Researchers and 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 based on mindfulness-based stress reduction treatment in either individual or group setting.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-12-01
Primary completion: 2025-12-01
Study completion finish: 2026-07-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06626438
Intervention or treatment
OTHER: Treatable traits model of care
Conditions
- • Interstitial Lung Diseases (ILD)
Find a site
Closest Location:
Fiona Stanley Hospital
Research sites nearby
Select from list below to view details:
Fiona Stanley Hospital
Perth, Washington, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Treatable Traits model of care
| OTHER: Treatable traits model of care
|
NO_INTERVENTION: Standard of Care
| Not specified |
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 12 months post intervention (14 months post enrolent) |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Progression free survival | the time to disease progression or death from any cause. | from enrolment to 12 months post intervention (14 months post enrolment) |
| Exercise capacity | 6 minute walk test assessment | from enrolment to 12 months post intervention (14 months post enrolment) |
Frequently Asked Questions
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