Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Treatable Traits in Interstitial Lung Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatable Traits in Interstitial Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTRILD
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 Kings 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None