Treatable Traits in Interstitial Lung Disease

NOT_YET_RECRUITING

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.

info
Simpliy with AI

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
  • info
    Simplify with AI

    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

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    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

    Loading...

    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/ArmIntervention/Treatment
    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.
    OTHER: Treatable traits model of care
    • Embedded multidisciplinary clinic with treatable traits model of care.
    NO_INTERVENTION: Standard of Care
    • Standard of care where physician-led ILD clinic. All referrals and comorbidity management as guided by physician.
    Not specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Health-related quality of lifeKings 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 MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Progression free survivalthe time to disease progression or death from any cause.from enrolment to 12 months post intervention (14 months post enrolment)
    Exercise capacity6 minute walk test assessmentfrom enrolment to 12 months post intervention (14 months post enrolment)

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: Treatable Traits in Interstitial Lung Disease

    Other trails to consider

    Top searched conditions