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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06122233
Registration number
NCT06122233
Ethics application status
Date submitted
2/11/2023
Date registered
8/11/2023
Titles & IDs
Public title
REBUILD-SM Study for People With Interstitial Lung Disease (ILD)
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Scientific title
A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
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Secondary ID [1]
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X23-0387
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial
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Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Pulmonary Fibrosis self-management package and smartphone application
Experimental: REBUILD-SM Group - Participants randomised to REBUILD-SM will receive the self-management package as well as the RE-BUILD app. Structured self-management support via telephone or Zoom call will be provided 4 times during the 12-week intervention period.
No intervention: Standard Care Group - In the control arm, participants will receive standard care and a reduced capability version of the RE-BUILD app to be used for data-capture only. They will also receive phone/Zoom calls at the same frequency during the 12-week intervention period, but no health advice will be given. After 26 weeks, participants in this group will receive access to the fully functional RE-BUILD app.
BEHAVIORAL: Pulmonary Fibrosis self-management package and smartphone application
The pulmonary fibrosis package includes modules on understanding treatment options for pulmonary fibrosis, managing medication and side effects, understanding and accessing clinical trials, managing shortness of breath, managing fatigue and mood, managing co-existing conditions, the role and importance of pulmonary rehabilitation and regular physical activity, role of oxygen therapy, smoking cessation advice and support, accessing community support, and communicating with others when living with pulmonary fibrosis.
The RE-BUILD app is used as a tool for data collection and to help participants self-monitor their disease over time. Participants enter their health data, including baseline conditions, medications and diagnosis, pulmonary function results and supplementary oxygen use. It also tracks air quality data close to the participant as well as physical activity level (step count). The app also has links to ILD-related educational resources.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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King's Brief Interstitial Lung Disease questionnaire (K-BILD)
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Assessment method [1]
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Score range 0 - 100; higher score corresponding to better outcome.
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Timepoint [1]
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Baseline and 12 weeks post-randomisation
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Secondary outcome [1]
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K-BILD
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Assessment method [1]
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As above
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Timepoint [1]
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26 and 52 weeks post-randomisation
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Secondary outcome [2]
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European Quality of Life 5-Dimensions 5-Level questionnaire
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Assessment method [2]
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Score range 11111 - 55555; 0-100; higher score indicating worse outcome
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Timepoint [2]
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Baseline, 12, 26 and 52 weeks post-randomisation
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Secondary outcome [3]
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General Self-Efficacy Scale
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Assessment method [3]
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Score range 10 - 40; higher score indicating low level of perceived self-efficacy
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Timepoint [3]
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Baseline, 12, 26, and 52 weeks post-randomisation
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Secondary outcome [4]
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Dyspnoea-12
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Assessment method [4]
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Score range 0-36; higher score corresponding to greater level of dyspnoea
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Timepoint [4]
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Baseline, 12, 26 and 52 weeks post-randomisation
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Secondary outcome [5]
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Hospital Anxiety and Depression Scale
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Assessment method [5]
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Score range 0-21 (for anxiety and depression); higher scores corresponding to severe anxiety and/or depression
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Timepoint [5]
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Baseline, 12, 26 and 52 weeks post-randomisation
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Secondary outcome [6]
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Physical activity levels (STEPWatch - physical activity monitor)
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Assessment method [6]
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Number of steps/day at beginning of intervention vs. end of intervention and end of follow-up period
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Timepoint [6]
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Baseline, 12 and 52 weeks post-randomisation
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Secondary outcome [7]
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Uptake/changes to ILD treatments
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Assessment method [7]
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Whether participant commenced a new or modified an existing ILD treatment
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Timepoint [7]
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Baseline, 12, 26 and 52 weeks post-randomisation
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Secondary outcome [8]
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mHealth Usability questionnaire
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Assessment method [8]
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Score range 18-126; higher score indicating greater satisfaction with the RE-BUILD app
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Timepoint [8]
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26 and 52 weeks post-randomisation
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Secondary outcome [9]
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E-Health Literacy questionnaire
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Assessment method [9]
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Score range 8-40; higher score indicating higher degree of perceived e-health literacy
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Timepoint [9]
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Baseline,12 and 52 weeks post-randomisation
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Secondary outcome [10]
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Health Care Climate questionnaire
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Assessment method [10]
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Score range 6-42; higher score indicating greater satisfaction with treating team
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Timepoint [10]
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12 weeks post-randomisation
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Eligibility
Key inclusion criteria
* Diagnosis of fibrotic ILD
* In possession of a smartphone/tablet and an email address
* Able to understand written and spoken English
* Adequate digital literacy to complete requirements of trial
* On stable ILD treatment for 30 days prior to enrolment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Not in possession of a smartphone/tablet
* Insufficient digital literacy to complete requirements of trial
* Unable to communicate in written/spoken English
* Not on stable ILD treatment for 30 days prior to enrolment
* Acute exacerbation within 30 days prior to enrolment
* Participating in pulmonary rehab at enrolment or planning to participate during 12-week intervention period
* Unable to provide informed consent
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2027
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [3]
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Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Lung Foundation Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Tasmania
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical trial is to compare REBUILD-SM (a purpose-built smartphone app and self-management package) with standard care in people with interstitial lung disease (ILD). The main question it aims to answer is: • Does REBUILD-SM improve health-related quality of life, symptoms, anxiety, self-efficacy and physical activity for people with ILD? Participants in the intervention group will work through the self-management package with support from a healthcare professional via phone or Zoom. They will also enter deidentified health data into the RE-BUILD smartphone app to track their progress over time. Participants in the control group will use a reduced functionality version of the smartphone app only. Researchers will compare both groups to see if there is any difference in health-related quality of life, symptoms, anxiety, self-efficacy and level of physical activity.
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Trial website
https://clinicaltrials.gov/study/NCT06122233
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tamera Corte
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carly Barton
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Address
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Country
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Phone
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+61 2 9515 5682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified data will be placed in a secure repository for future analysis.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
The data will be available at the end of the trial (approx. April 2028).
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Available to whom?
Requires ethical approval
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06122233