REBUILD-SM Study for People With Interstitial Lung Disease (ILD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Fibrosis; Lung Diseases, Interstitial
• Intervention / Treatment: Behavioral: Pulmonary Fibrosis self-management package and smartphone application

Detailed Description

This study compares REBUILD-SM with standard care in people with ILD. REBUILD-SM comprises a purpose-built smartphone app that allows subjects to enter and track health data over time and an integrated self-management website.

Participants will enter their respiratory diagnosis, medications and side effects, weight, lung function test results, oxygen saturation level and supplemental oxygen usage into the smartphone app. They will also use the app to answer questionnaires at specific timepoints. Participants will input most of this data at the beginning of the trial and then update it when it changes, for example, after obtaining a new lung function result, starting a new medication or getting a new side effect from an existing medication. Entering data into the app is expected to take around 30 minutes at the start of the trial, and about 20 minutes at 12, 26 and 52 weeks when completing the questionnaires. Updating data is expected to take about 5-10 minutes and will only happen when there is a change, for example, once per week, although it may not be this frequent.

The app will not provide any recommendations on the health data participants enter - it is simply for recording purposes. To ensure data collection is as complete as possible, electronic reminders will be sent when questionnaires are not completed at the specified timepoints, and app analytics will be used to monitor use of the app and will alert the study team if the participant fails to complete the questionnaires in response to the reminder. This will prompt a phone call from a member of the study team, but this is the extent to which app analytics will be used during the trial. App analytics will be used in the data analysis phase (after the trial is over) to understand how participants engaged with the app.

Participants in the intervention group will be asked to log into and use the self-management website with support from the study team. The self-management website includes 12 modules and has been designed in collaboration with people with ILD to help increase their ability to self-manage their chronic disease.

During the intervention period, participants will receive four phone calls from a health professional involved in the management of people with ILD to help them set health-related goals and identify appropriate modules from the website to help participants achieve these goals. These four phone calls are expected to take about 15-30 minutes each.

Each module provides information regarding the topic and provides access to relevant websites, fact sheets, booklets, videos and webinars as well as other external resources. Participants will have direct access to these external resources from within the package through hyperlinks embedded in the title of each resource. Participants are expected to work through their selected modules at their own pace - there is no specific amount of time they are required to allocate to the intervention, and they can utilize as many or as few of the resources as they like. Adherence to the intervention will be monitored solely through the four phone calls and is participant-reported.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carly Barton; Phone Number: +61 2 9515 5682; Email: Carly.Barton@Sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
      • Contact: Carly Barton; Phone Number: +61 2 9515 5682; Email: Carly.Barton@Sydney.edu.au
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital
      • Contact: Sjane Timmins; Phone Number: +61 7 3139 6298; Email: Sjane.Timmins@health.qld.gov.au
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Health
      • Contact: Lisa Fuhrmeister; Phone Number: +61 3 9496 3874; Email: Lisa.Fuhrmeister@austin.org.au
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
      • Contact: Karen Symons; Phone Number: +61 3 9076 3600; Email: K.Symons@Alfred.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of fibrotic ILD
• In possession of a smartphone/tablet
• Able to understand written and spoken English
• Adequate digital literacy to complete requirements of trial

Exclusion Criteria:

• 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 randomisation
• Participating in pulmonary rehab at enrolment
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REBUILD-SM Group; Participants randomised to REBUILD-SM will receive the self-management package as well as the RE-BUILD app. Structured self-management support via telephone or Zoom call will be provided 4 times during the 12-week intervention period.	Behavioral: Pulmonary Fibrosis self-management package and smartphone application; The 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 track their health 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 and physical activity via the phone's step count and has links to ILD-related educational resources.; Other Names: REBUILD-SM
No Intervention: Standard Care Group; In the control arm, participants will receive standard care and a reduced capability version of the RE-BUILD 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 RE-BUILD app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
King's Brief Interstitial Lung Disease questionnaire (K-BILD)	Score range 0 - 100; higher score corresponding to better outcome.	Baseline and 12 weeks post-randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-BILD	As above	26 and 52 weeks post-randomisation
European Quality of Life 5-Dimensions 5-Level questionnaire	Score range 11111 - 55555; 0-100; higher score indicating worse outcome	Baseline, 12, 26 and 52 weeks post-randomisation
General Self-Efficacy Scale	Score range 10 - 40; higher score indicating low level of perceived self-efficacy	Baseline, 12, 26, and 52 weeks post-randomisation
Dyspnoea-12	Score range 0-36; higher score corresponding to greater level of dyspnoea	Baseline, 12, 26 and 52 weeks post-randomisation
Hospital Anxiety and Depression Scale	Score range 0-21 (for anxiety and depression); higher scores corresponding to severe anxiety and/or depression	Baseline, 12, 26 and 52 weeks post-randomisation
Steps per day (STEPWatch - physical activity monitor)	Number of steps/day at beginning of study vs. end of study	Baseline and 26 weeks post-randomisation
Uptake/changes to ILD treatments	Whether participant had commenced or modified their ILD medication	Baseline, 12, 26 and 52 weeks post-randomisation
mHealth Usability questionnaire	Score range 18-126; higher score indicating greater satisfaction with the RE-BUILD app	Baseline, 26 and 52 weeks post-randomisation
E-Health Literacy questionnaire	Score range 8-40; higher score indicating higher degree of perceived e-health literacy	Baseline and 12 weeks post-randomisation
Health Care Climate questionnaire	Score range 6-42; higher score indicating greater satisfaction with treating team	Baseline and 12 weeks post-randomisation

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: Monash University; University of Tasmania; Lung Foundation Australia
• Investigators: Principal Investigator: Tamera Corte, University of Sydney; Principal Investigator: Dan Chambers, The University of Queensland; Principal Investigator: Nicole Goh, Institute of Breathing and Sleep; Principal Investigator: Ian Glaspole, The Alfred

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Self-Management; Chronic diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Fibrosis; Lung Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: X23-0387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be placed in a secure repository for future analysis.
• IPD Sharing Time Frame: The data will be available at the end of the trial (approx. April 2028).
• IPD Sharing Access Criteria: Requires ethical approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No