An interventional study of Pulmonary Fibrosis self-management package and smartphone application in Lung Diseases, Interstitial and Pulmonary Fibrosis, sponsored by University of Sydney. Recruiting at 4 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University of Sydney · Not applicable, Interventional, and Supportive care
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:
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.
This study compares REBUILD-SM with standard care in people with 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 package.
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 complete questionnaires at specific timepoints using the app. Participants will input most of this data at the beginning of the trial and 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 to participants when questionnaires are not completed at the specified timepoints and will alert the study team if the participant fails to complete the questionnaires after the reminder. This will prompt a phone call from a member of the study team to encourage the participant to complete the endpoints. App analytics will be used in the data analysis phase (after the trial is over) to understand how participants have engaged with the app.
Participants in the intervention group will be asked to log into and use the self-management website or view the content via the REBUILD app with support from the study team. The self-management content includes 13 modules and has been designed in collaboration with people with ILD to help increase their ability to self-manage their chronic disease.
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 utilize as many or as few of the resources as they like.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 400 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomised to the intervention will receive the self-management package, including the REBUILD app. Structured self-management support via telephone or Zoom call will be provided 4 times during the 12-week intervention period.
Behavioral: Pulmonary Fibrosis self-management package and smartphone application
In the control arm, participants will receive standard care and a reduced capability version of the REBUILD 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 REBUILD app, however they will not receive the self-management content or the support phone calls provided to the intervention group.
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.
Also known as: REBUILD-SM
Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score
Score range 0 - 100; higher score corresponding to better outcome.
Time frame: Baseline and 12 weeks post-randomisation
Change in K-BILD score
As above
Time frame: 26 and 52 weeks post-randomisation
Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score
Score range 11111 - 55555; 0-100; higher score indicating worse outcome
Time frame: Baseline, 12, 26 and 52 weeks post-randomisation
Change in General Self-Efficacy Scale score
Score range 10 - 40; higher score indicating low level of perceived self-efficacy
Time frame: Baseline, 12, 26, and 52 weeks post-randomisation
Change in Dyspnoea-12 score
Score range 0-36; higher score corresponding to greater level of dyspnoea
Time frame: Baseline, 12, 26 and 52 weeks post-randomisation
Change in Hospital Anxiety and Depression Scale score
Score range 0-21 (for anxiety and depression); higher scores corresponding to severe anxiety and/or depression
Time frame: Baseline, 12, 26 and 52 weeks post-randomisation
Change in physical activity levels
Change in steps per day and change in time spent in the four intensity categories (inactive, low, medium and high activity) will be measured using a physical activity monitor
Time frame: Baseline, 12 and 52 weeks post-randomisation
Uptake/ changes to ILD treatments
Includes changes to medications, commencement or change in supplemental oxygen use, participation in pulmonary rehab
Time frame: Baseline, 12, 26 and 52 weeks post-randomisation
Change in mHealth App Usability questionnaire (MAUQ) score
Score range 18-126; higher score indicating greater satisfaction with the REBUILD app
Time frame: 12, 26 and 52 weeks post-randomisation
Change in e-Health Literacy (eHEALS) questionnaire score
Score range 8-40; higher score indicating higher degree of perceived e-health literacy
Time frame: Baseline,12 and 52 weeks post-randomisation
Health Care Climate questionnaire
Score range 6-42; higher score indicating greater satisfaction with treating team
Time frame: 12 weeks post-randomisation
Plan to share: Yes — Deidentified data will be placed in a secure repository for future analysis.
Supporting information: Study protocol, Sap
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University of Sydney