REBUILD-SM Trial

About the Study

Disease target: Interstitial Lung Disease

Recruitment target: 400 participants

Duration: Intervention period of 12 weeks, with follow-up at 26 and 52 weeks.

Study Locations

NSW

  • Royal Prince Alfred Hospital 

VIC

  • The Alfred 
  • Austin Health 

QLD

  • The Prince Charles Hospital 

What is involved?

This intervention aims to determine if a smartphone application and self- management package designed for people with ILD will improve quality of life, reduce anxiety, depression, and symptoms, and increase physical activity and sense of autonomy.

It will also investigate if the intervention will help patients (and the healthcare system) reduce the cost and burden of managing ILD.

Investigational medicinal product, comparator and randomisation

  • The intervention group will have access to web-based learning modules and support from a self-management clinician, who will engage with the participant four times during the study via phone or video call.
  • The comparator is standard of care with the addition of a reduced functionality version of the app (i.e. without educational resources). Patients in the control group will also receive phone calls at the same frequency to control for the effects of attention.
  • Randomisation will be in a 1:1 allocation (intervention vs control) and will be stratified for FVC (51% or more; 50% or less); site; and diagnosis (IPF or other).

Can I participate?

Inclusion Criteria
  • 18 years or older
  • Able to provide consent
  • Able to read and write adequately in English
  • Owns a smartphone / tablet
  • Digitally literate
  • Have an email address
  • On stable treatment for ILD for the previous 30 days prior to enrolment
Exclusion Criteria
  • Less than 18 years
  • Unable to consent
  • Unable to read and write adequately in English
  • Not on stable ILD treatment for the previous 30 days prior to enrolment
  • Acute exacerbation in the 30 days prior to enrolment
  • Participating in pulmonary rehabilitation at enrolment or during the 12-week intervention period
  • Death or transplant expected within the trial period

Further information or how to take part

If you would like to take part or have any questions about this research study, please complete our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.

This study is sponsored by The University of Sydney.

Clinicaltrials.gov ID: NCT06122233
 

Key Trial Information

  • Trial Location: NSW , QLD , VIC
  • Trial Category: Featured
  • Trial Phase: Not applicable
  • Trial Status: Recruiting
  • Trial Type: Interventional
  • Trial Disease Type: Interstitial Lung Disease (ILD)
  • Trial Age Group: Over 18 years
  • Trial Participant Type: Patient