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

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.

Conditions

• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Monash University

  collaborator OTHER

• Lung Foundation Australia

  collaborator UNKNOWN

• University of Tasmania

  collaborator OTHER

• University of Sydney

  lead OTHER

Principal Investigators

• Tamera Corte · University of Sydney

• Dan Chambers · The University of Queensland

• Nicole Goh · Institute of Breathing and Sleep

• Ian Glaspole · The Alfred

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-03

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• Australia

Study Locations