Learn about Research & Clinical Trials

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06122233
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Sydney
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tamera CorteDan ChambersNicole GohIan Glaspole
Principal Investigator Affiliation University of SydneyThe University of QueenslandInstitute of Breathing and SleepThe Alfred
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial, Pulmonary Fibrosis
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Status

Address

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050

Site Contact

Carly Barton

Carly.Barton@Sydney.edu.au

+61 2 9515 5682

The Prince Charles Hospital, Brisbane, Queensland, Australia

Status

Address

The Prince Charles Hospital

Brisbane, Queensland, 4032

Alfred Hospital, Melbourne, Victoria, Australia

Status

Address

Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Karen Symons

K.Symons@Alfred.org.au

+61 3 9076 3600

Austin Health, Melbourne, Victoria, Australia

Status

Address

Austin Health

Melbourne, Victoria, 3084

Site Contact

Lisa Fuhrmeister

Lisa.Fuhrmeister@austin.org.au

+61 3 9496 3874