Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06122233

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

Led by University of Sydney · Updated on 2025-04-04

400

Participants Needed

4

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Sydney

Lead Sponsor

M

Monash University

Collaborating Sponsor

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 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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

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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

Trial Site Locations

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

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Research Team

C

Carly Barton

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

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/41350860

Usability of a smartphone application for patients with interstitial lung disease: Results from the Registry for Better Understanding of ILD (RE-BUILD) pilot study.

Laura M Glenn, Dan Jackson, Carly Barton...

https://pubmed.ncbi.nlm.nih.gov/39689971