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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score — Baseline and 12 weeks post-randomisation
  Score range 0 - 100; higher score corresponding to better outcome.

Trial sites (4)

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