Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-09-03
2027-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatable Traits model of care
Embedded multidisciplinary clinic. This involves multidimensional assessment of patients with MDT review to determine presence of treatable traits and their specific management.
Treatable traits model of care
Embedded multidisciplinary clinic with treatable traits model of care.
Standard of Care
Standard of care where physician-led ILD clinic. All referrals and comorbidity management as guided by physician.
No interventions assigned to this group
Interventions
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Treatable traits model of care
Embedded multidisciplinary clinic with treatable traits model of care.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Fiona Stanley Hospital
OTHER
Sir Charles Gairdner Hospital
OTHER
The University of Western Australia
OTHER
Responsible Party
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Megan Harrison
Dr.
Principal Investigators
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Yuben Moodley, MBSS, FRACP, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Locations
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Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MRFF2022914
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RGS0000006668
Identifier Type: -
Identifier Source: org_study_id
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