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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
The Prince Charles Hospital
RECRUITING
Brisbane
Alfred Hospital
RECRUITING
Melbourne
Austin Health
RECRUITING
Melbourne
Royal Prince Alfred Hospital
RECRUITING
Sydney
Contact Information
Primary
Carly Barton
Carly.Barton@Sydney.edu.au
+61 2 9515 5682
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2027-08
Participants
Target number of participants: 400
Treatments
Experimental: REBUILD-SM Group
Participants randomised to the intervention will receive the self-management package, including the REBUILD app. Structured self-management support via telephone or Zoom call will be provided 4 times during the 12-week intervention period.
No_intervention: Standard Care Group
In the control arm, participants will receive standard care and a reduced capability version of the REBUILD app to be used for data-capture only. They will also receive phone/Zoom calls at the same frequency during the 12-week intervention period, but no health advice will be given. After 26 weeks, participants in this group will receive access to the fully functional REBUILD app, however they will not receive the self-management content or the support phone calls provided to the intervention group.
Sponsors
Collaborators: Monash University, Lung Foundation Australia, University of Tasmania
Leads: University of Sydney

This content was sourced from clinicaltrials.gov