A randomised clinical trial of a digital self-management package for people with interstitial lung disease: the REBUILD-SM protocol.
Carly Barton, Mariana Hoffman, Narelle S Cox...
https://pubmed.ncbi.nlm.nih.gov/41350860Actively Recruiting
Led by University of Sydney · Updated on 2025-04-04
400
Participants Needed
4
Research Sites
8 weeks
Total Duration
U
University of Sydney
Lead Sponsor
M
Monash University
Collaborating Sponsor
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 King's 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
A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
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
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
Total: 4 locations
1
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Actively Recruiting
2
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
Actively Recruiting
3
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
4
Austin Health
Melbourne, Victoria, Australia, 3084
Actively Recruiting
C
Carly Barton
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Carly Barton, Mariana Hoffman, Narelle S Cox...
https://pubmed.ncbi.nlm.nih.gov/41350860Laura M Glenn, Dan Jackson, Carly Barton...
https://pubmed.ncbi.nlm.nih.gov/39689971