Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001133628
Ethics application status
Approved
Date submitted
10/10/2023
Date registered
2/11/2023
Date last updated
29/09/2024
Date data sharing statement initially provided
2/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial)
Scientific title
A Randomised Clinical Trial of the effect of a digital Self-Management package on health-related quality of life for people with Interstitial Lung Disease (REBUILD-SM trial)
Secondary ID [1] 310577 0
None
Universal Trial Number (UTN)
U1111-1303-0802
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 331729 0
Condition category
Condition code
Respiratory 328476 328476 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares REBUILD-SM with standard care in people with interstitial lung disease (ILD). REBUILD-SM comprises a purpose-built smartphone app that allows subjects to enter and track health data over time and an integrated self-management website.

Participants will enter their respiratory diagnosis, medications and side effects, weight, lung function test results, oxygen saturation level and supplemental oxygen usage into the smartphone app. They will also use the app to complete questionnaires at specific timepoints. Participants will input most of this data at the beginning of the trial and then update it when it changes, for example, after obtaining a new lung function result, starting a new medication or getting a new side effect from an existing medication. Entering data into the app is expected to take around 30 minutes at the start of the trial, and about 20 minutes at 12, 26 and 52 weeks when completing the questionnaires. Updating data is expected to take about 5-10 minutes and will only happen when there is a change, for example, once per week, although it may not be this frequent.

The app will not provide any recommendations on the health data participants enter - it is simply for recording purposes. To ensure data collection is as complete as possible, electronic reminders will be sent when questionnaires are not completed at the specified timepoints and will alert the study team if the participant fails to complete the questionnaires in response to the reminder. This will prompt a phone call from a member of the study team to encourage endpoint completion. App analytics will be used in the data analysis phase (after the trial is over) to understand how participants engaged with the app.

Participants in the intervention group will be asked to log into and use the self-management website with support from the study team. The self-management website includes the following 12 modules: understanding treatment options for pulmonary fibrosis; managing co-existing medical conditions; managing medications and side effects; role and importance of pulmonary rehabilitation and regular physical activity; understanding and accessing clinical trials; role of oxygen therapy; managing shortness of breath; smoking cessation advice and support; managing fatigue; accessing community support; managing mood; how to communicate with others when living with pulmonary fibrosis.

During the intervention period, participants will receive four phone calls from a health professional involved in the management of people with ILD to help them set health-related goals and identify appropriate modules from the website to help achieve these goals. These four phone calls are expected to take about 15-30 minutes each.

Each module provides information regarding the topic and provides access to relevant websites, fact sheets, booklets, videos and webinars as well as other external resources. Participants will have direct access to these external resources from within the package through hyperlinks embedded in the title of each resource. Participants are expected to work through their selected modules at their own pace – there is no specific amount of time they are required to allocate to the intervention, and they can utilise as many or as few of the resources as they like. Adherence to the intervention will be monitored through the four phone calls and engagement with the content.
Intervention code [1] 327176 0
Behaviour
Comparator / control treatment
The control group will receive standard ILD care from their usual treating health care team as well as a reduced functionality version of the RE-BUILD app for the purposes of data collection only i.e. without the self-management package or educational materials. The control group will also receive phone calls at the same frequency as the intervention group, however they will be general in nature and no health care advice will be provided.
Control group
Active

Outcomes
Primary outcome [1] 336298 0
Change in health-related quality of life will be measured by change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score.
Timepoint [1] 336298 0
Baseline and 12 weeks after randomisation
Secondary outcome [1] 427742 0
Change in health-related quality of life as measured by change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score.
Timepoint [1] 427742 0
Baseline, 12, 26 and 52 weeks after randomisation
Secondary outcome [2] 427743 0
Change in health-related quality of life as measured by change in K-BILD score.
Timepoint [2] 427743 0
26 and 52 weeks after randomisation
Secondary outcome [3] 427744 0
Change in self-efficacy as measured by change in General Self-Efficacy (GSE) scale score.
Timepoint [3] 427744 0
Baseline, 12, 26 and 52 weeks after randomisation
Secondary outcome [4] 427745 0
Change in dyspnoea level as measured by change in Dyspnoea-12 score.
Timepoint [4] 427745 0
Baseline, 12, 26 and 52 weeks after randomisation
Secondary outcome [5] 427746 0
Change in anxiety and depression as measured by change in Hospital Anxiety and Depression scale (HADS) score. This will be assessed as a composite outcome.
Timepoint [5] 427746 0
Baseline, 12, 26 and 52 weeks after randomisation
Secondary outcome [6] 427766 0
Change in physical activity levels as measured by change in number of steps per day and change in time spent in the four intensity categories (inactive, low, medium and high activity). This will be measured using a physical activity monitor.
Timepoint [6] 427766 0
Baseline, 12 and 52 weeks after randomisation
Secondary outcome [7] 427767 0
Changes to ILD treatments, assessed using participant-entered data (RE-BUILD app) and review of participant's electronic medical record.
Timepoint [7] 427767 0
Baseline, 12, 26 and 52 weeks after randomisation.
Secondary outcome [8] 427768 0
Change to patient satisfaction and engagement as measured by change in mHealth App Usability questionnaire (MAUQ) score.
Timepoint [8] 427768 0
26 and 52 weeks after randomisation
Secondary outcome [9] 427769 0
Change in e-health literacy as measured by change in eHealth and Literacy Scale (eHEALS) score.
Timepoint [9] 427769 0
Baseline, 12 and 52 weeks after randomisation
Secondary outcome [10] 427770 0
Extent to which participants perceive the RE-BUILD app as an autonomy supportive healthcare interaction will be measured using the Health Care Climate questionnaire.
Timepoint [10] 427770 0
Week 12 after randomisation only.

Eligibility
Key inclusion criteria
• Physician confirmed diagnosis of interstitial lung disease (ILD)
• Able to provide informed consent
• Able to read written English or have someone reading for them in their preferred language
• Able to speak English
• Own a smartphone or tablet compatible with RE-BUILD App
• Digital literacy to be able to download and use smartphone application
• Have an email address
• On stable treatment for ILD for 1 month (no changes to ILD medications within 1 month prior to recruitment)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to communicate in English
• Unable to consent due to cognitive impairment or other reason
• Not on stable treatment for ILD (changes to ILD medications within the previous 1 month)
• Currently participating in pulmonary rehabilitation
• Death or transplant anticipated within the study period
• Digital illiteracy preventing download and use of apps

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Efficacy
Statistical methods / analysis
It is estimated a sample size of 400 subjects randomised equally between standard care and the REBUILD-SM intervention will offer 82% power at 2P=0.05 to identify as statistically signficant a clinically important difference of 5 KBILD units from mean 55.3 (SD 15.6) in usual care to 60.3 with the intervention treatment package after accounting for up to 10% non-compliance with allocated therapy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
7/06/2024
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
400
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 25719 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 25720 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 25721 0
The Alfred - Melbourne
Recruitment hospital [4] 25722 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 41543 0
2050 - Camperdown
Recruitment postcode(s) [2] 41544 0
4032 - Chermside
Recruitment postcode(s) [3] 41545 0
3004 - Melbourne
Recruitment postcode(s) [4] 41546 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 314787 0
Government body
Name [1] 314787 0
National Health & Medical Research Council
Country [1] 314787 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
1-3 Ross St, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 316774 0
None
Name [1] 316774 0
Address [1] 316774 0
Country [1] 316774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313799 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313799 0
Ethics committee country [1] 313799 0
Australia
Date submitted for ethics approval [1] 313799 0
06/10/2023
Approval date [1] 313799 0
19/12/2023
Ethics approval number [1] 313799 0
X23-0387 & 2023/ETH02021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129378 0
Prof Tamera Corte
Address 129378 0
Respiratory Dept, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 129378 0
Australia
Phone 129378 0
+61 2 9515 6120
Fax 129378 0
Email 129378 0
[email protected]
Contact person for public queries
Name 129379 0
Carly Barton
Address 129379 0
Respiratory Dept, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 129379 0
Australia
Phone 129379 0
+61 2 9515 5682
Fax 129379 0
Email 129379 0
[email protected]
Contact person for scientific queries
Name 129380 0
Tamera Corte
Address 129380 0
Respiratory Dept, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 129380 0
Australia
Phone 129380 0
+61 2 9515 6120
Fax 129380 0
Email 129380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.