Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06626438




Registration number
NCT06626438
Ethics application status
Date submitted
1/10/2024
Date registered
3/10/2024
Date last updated
3/10/2024

Titles & IDs
Public title
Treatable Traits in Interstitial Lung Disease
Scientific title
Treatable Traits in Interstitial Lung Disease
Secondary ID [1] 0 0
MRFF2022914
Secondary ID [2] 0 0
RGS0000006668
Universal Trial Number (UTN)
Trial acronym
TTRILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Diseases (ILD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Treatable traits model of care

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.


Other interventions: Treatable traits model of care
Embedded multidisciplinary clinic with treatable traits model of care.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Health-related quality of life
Timepoint [1] 0 0
from enrolment to 12 months post intervention (14 months post enrolent)
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
from enrolment to 12 months post intervention (14 months post enrolment)
Secondary outcome [2] 0 0
Exercise capacity
Timepoint [2] 0 0
from enrolment to 12 months post intervention (14 months post enrolment)

Eligibility
Key inclusion criteria
* Interstitial lung disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Washingto
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
6150 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06626438
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yuben Moodley, MBSS, FRACP, MD, PHD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Megan Harrison, MBSS (Hons) FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 08 6457 3333
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06626438