Study Comparing a Digital Self-Management App With Standard Care for Adults Living With Interstitial Lung Disease
Led by University of Sydney · Updated on 2025-04-04
400
Participants Needed
4
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a digital self-management package called REBUILD-SM designed for people with interstitial lung disease ILD. The study aims to find out whether REBUILD-SM can improve health-related quality of life, symptoms, anxiety, self-confidence in managing illness, and physical activity levels compared to standard care. REBUILD-SM combines a smartphone app with a self-management program developed in collaboration with people living with ILD to support better disease management.
Participants in the intervention group will use the REBUILD app to enter and track health data such as diagnosis, medications, lung function, and oxygen use. They will also work through 13 self-management modules at their own pace with support from healthcare professionals through four phone or Zoom calls over a 12-week period. The control group will use a simpler version of the app for data entry only and receive calls without health advice. After 26 weeks, control participants will gain access to the full app but not the self-management content or support calls.
During the study, participants will complete questionnaires and update their health data at baseline, 12, 26, and 52 weeks. Electronic reminders and follow-up calls will encourage questionnaire completion. Researchers will measure changes using questionnaires on lung disease impact, quality of life, anxiety, physical activity, and self-efficacy. The main outcome is change in the Kings Brief Interstitial Lung Disease questionnaire score at 12 weeks. The study includes ongoing monitoring up to 52 weeks to assess longer-term effects and app usability.
CONDITIONS
Brief Title
A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
Research Team
C
Carly Barton
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Diagnosis of fibrotic interstitial lung disease (ILD)
Own a smartphone or tablet and have an email address
Able to understand written and spoken English
Have adequate digital skills to complete trial tasks
On stable ILD treatment for at least 30 days before enrollment
You will not qualify if you...
Do not own a smartphone or tablet
Insufficient digital skills to complete trial tasks
Unable to communicate in written or spoken English
Not on stable ILD treatment for at least 30 days before enrollment
Had an acute ILD exacerbation within 30 days before enrollment
Currently participating in pulmonary rehabilitation or plan to during the 12-week intervention
Unable to provide informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Treatment
Duration - 12 weeks
Participants use the REBUILD self-management smartphone app to enter and track their health data and complete questionnaires. The intervention group receives self-management support via four phone or Zoom calls over 12 weeks to help set health goals and access educational modules. Participants work through the self-management content at their own pace without a required time commitment.
4 phone or Zoom calls and periodic app use over 12 weeks
Follow-up
Duration - Up to 40 weeks after treatment
Participants continue to use the app to complete questionnaires at 26 and 52 weeks to monitor changes in health and quality of life. Data entry updates occur as needed when health changes.
Questionnaires completed at 26 and 52 weeks post-randomisation
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Usability of a smartphone application for patients with interstitial lung disease: Results from the Registry for Better Understanding of ILD (RE-BUILD) pilot study.