RecruitingNot ApplicableNCT06122233

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

Sponsor

University of Sydney

Enrollment

400 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Diseases, Interstitial Pulmonary Fibrosis

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

Min Age: 18 Years

Inclusion Criteria5

Diagnosis of fibrotic ILD
In possession of a smartphone/tablet and an email address
Able to understand written and spoken English
Adequate digital literacy to complete requirements of trial
On stable ILD treatment for 30 days prior to enrolment

Exclusion Criteria7

Not in possession of a smartphone/tablet
Insufficient digital literacy to complete requirements of trial
Unable to communicate in written/spoken English
Not on stable ILD treatment for 30 days prior to enrolment
Acute exacerbation within 30 days prior to enrolment
Participating in pulmonary rehab at enrolment or during 12-week intervention period
Unable to provide informed consent

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Interventions

BEHAVIORALPulmonary 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.