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Treatable Traits in Interstitial Lung Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06626438
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Western Australia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuben Moodley, MBSS, FRACP, MD, PHD
Principal Investigator Affiliation	The University of Western Australia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Diseases (ILD)

Additional 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.#46;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.

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Standard of Care

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

Interventions

Other: - Treatable traits model of care

Embedded multidisciplinary clinic with treatable traits model of care.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.