A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial)

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 13 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.