A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not in possession of a smartphone/tablet
Insufficient digital literacy to complete requirements of trial
Unable to communicate in written/spoken English
Not on stable ILD treatment for 30 days prior to enrolment
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary Fibrosis self-management package and smartphone application
BehavioralThe pulmonary fibrosis package includes modules on understanding treatment options for pulmonary fibrosis, managing medication and side effects, understanding and accessing clinical trials, managing shortness of breath, managing fatigue and mood, managing co-existing conditions, the role and importance of pulmonary rehabilitation and regular physical activity, role of oxygen therapy, smoking cessation advice and support, accessing community support, and communicating with others when living with pulmonary fibrosis. The RE-BUILD app is used as a tool for data collection and to help participants self-monitor their disease over time. Participants enter their health data, including baseline conditions, medications and diagnosis, pulmonary function results and supplementary oxygen use. It also tracks air quality data close to the participant as well as physical activity level (step count). The app also has links to ILD-related educational resources.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: REBUILD-SM GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score
Score range 0 - 100; higher score corresponding to better outcome.
Time frame
Baseline and 12 weeks post-randomisationSecondary outcomes
1
Change in K-BILD score
As above
Time frame
26 and 52 weeks post-randomisation2
Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score
Score range 11111 - 55555; 0-100; higher score indicating worse outcome
Time frame
Baseline, 12, 26 and 52 weeks post-randomisation3
Change in General Self-Efficacy Scale score
Score range 10 - 40; higher score indicating low level of perceived self-efficacy
Time frame
Baseline, 12, 26, and 52 weeks post-randomisation4
Change in Dyspnoea-12 score
Score range 0-36; higher score corresponding to greater level of dyspnoea
Time frame
Baseline, 12, 26 and 52 weeks post-randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sydney
Lead sponsor
Monash University
Collaborator
Lung Foundation Australia
Collaborator
University of Tasmania
Collaborator
Source ClinicalTrials.gov