A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease

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.

• Change in K-BILD score [Срок оценки: 26 and 52 weeks post-randomisation]
• Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score [Срок оценки: Baseline, 12, 26 and 52 weeks post-randomisation]
• Change in General Self-Efficacy Scale score [Срок оценки: Baseline, 12, 26, and 52 weeks post-randomisation]
• Change in Dyspnoea-12 score [Срок оценки: Baseline, 12, 26 and 52 weeks post-randomisation]
• Change in Hospital Anxiety and Depression Scale score [Срок оценки: Baseline, 12, 26 and 52 weeks post-randomisation]
• Change in physical activity levels [Срок оценки: Baseline, 12 and 52 weeks post-randomisation]
• Uptake/ changes to ILD treatments [Срок оценки: Baseline, 12, 26 and 52 weeks post-randomisation]
• Change in mHealth App Usability questionnaire (MAUQ) score [Срок оценки: 12, 26 and 52 weeks post-randomisation]
• Change in e-Health Literacy (eHEALS) questionnaire score [Срок оценки: Baseline,12 and 52 weeks post-randomisation]
• Health Care Climate questionnaire [Срок оценки: 12 weeks post-randomisation]