Clinical trial NCT06626438: Treatable Traits in Interstitial Lung Disease
Official title: Treatable Traits in Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Diseases (ILD)
Keywords: treatable traits
interstitial lung disease
pulmonary fibrosis
multidisciplinary
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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: Inclusion Criteria:

* Interstitial lung disease

Exclusion Criteria:

* Unable to provide informed consent.
* Participants experiencing an infective or acute exacerbation 4 weeks prior to starting the study will also be excluded, as this may impact on primary and secondary outcomes.
* Acute suicidality, severe depression, active (e.g., untreated) psychosis or mania, dementia, 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: from enrolment to 12 months post intervention (14 months post enrolent)
Secondary outcomes:
measure: Progression free survival
timeFrame: from enrolment to 12 months post intervention (14 months post enrolment)
measure: Exercise capacity
timeFrame: from enrolment to 12 months post intervention (14 months post enrolment)
Other outcomes:
measure: Economic evaluation
timeFrame: from enrolment to 12 months post intervention (14 months post enrolment)
Locations:
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Washington
Study officials:
affiliation: The University of Western Australia
name: Yuben Moodley, MBSS, FRACP, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: