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| Name | Class |
|---|---|
| Monash University | OTHER |
| Lung Foundation Australia | UNKNOWN |
| University of Tasmania | OTHER |
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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.
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 package.
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 complete questionnaires at specific timepoints using the app. Participants will input most of this data at the beginning of the trial and 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 to participants when questionnaires are not completed at the specified timepoints and will alert the study team if the participant fails to complete the questionnaires after the reminder. This will prompt a phone call from a member of the study team to encourage the participant to complete the endpoints. App analytics will be used in the data analysis phase (after the trial is over) to understand how participants have engaged with the app.
Participants in the intervention group will be asked to log into and use the self-management website or view the content via the REBUILD app with support from the study team. The self-management content includes 13 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REBUILD-SM Group | Experimental | 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. |
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| Standard Care Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Fibrosis self-management package and smartphone application | Behavioral | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score | Score range 0 - 100; higher score corresponding to better outcome. | Baseline and 12 weeks post-randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in K-BILD score | As above | 26 and 52 weeks post-randomisation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Barton | Contact | +61 2 9515 5682 | Carly.Barton@Sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Tamera Corte | University of Sydney | Principal Investigator |
| Dan Chambers | The University of Queensland | Principal Investigator |
| Nicole Goh |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Recruiting | Sydney | New South Wales | 2050 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41350860 | Derived | Barton C, Hoffman M, Cox NS, Glenn LM, Lee JYT, Cox I, Goh NSL, Troy LK, Mackintosh J, Chambers DC, Glaspole IN, Gebski V, Keech A, Palmer A, Laranjo L, Knibbs LD, Moodley Y, Brooke M, Holland AE, Corte TJ. A randomised clinical trial of a digital self-management package for people with interstitial lung disease: the REBUILD-SM protocol. Respir Res. 2025 Dec 5;27(1):14. doi: 10.1186/s12931-025-03442-z. | |
| 39689971 |
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Deidentified data will be placed in a secure repository for future analysis.
The data will be available at the end of the trial (approx. April 2028).
Requires ethical approval
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Due to the nature of the intervention, blinding will not be possible for participants and care providers (i.e. healthcare professionals making phone calls to participants). Where practicable, members of the investigative team will be blinded. Outcome assessors will also be blinded.
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| Baseline, 12, 26 and 52 weeks post-randomisation |
| Change in General Self-Efficacy Scale score | Score range 10 - 40; higher score indicating low level of perceived self-efficacy | Baseline, 12, 26, and 52 weeks post-randomisation |
| Change in Dyspnoea-12 score | Score range 0-36; higher score corresponding to greater level of dyspnoea | Baseline, 12, 26 and 52 weeks post-randomisation |
| Change in Hospital Anxiety and Depression Scale score | 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 |
| Change in physical activity levels | Change in steps per day and change in time spent in the four intensity categories (inactive, low, medium and high activity) will be measured using a physical activity monitor | Baseline, 12 and 52 weeks post-randomisation |
| Uptake/ changes to ILD treatments | Includes changes to medications, commencement or change in supplemental oxygen use, participation in pulmonary rehab | Baseline, 12, 26 and 52 weeks post-randomisation |
| Change in mHealth App Usability questionnaire (MAUQ) score | Score range 18-126; higher score indicating greater satisfaction with the REBUILD app | 12, 26 and 52 weeks post-randomisation |
| Change in e-Health Literacy (eHEALS) questionnaire score | Score range 8-40; higher score indicating higher degree of perceived e-health literacy | Baseline,12 and 52 weeks post-randomisation |
| Health Care Climate questionnaire | Score range 6-42; higher score indicating greater satisfaction with treating team | 12 weeks post-randomisation |
| Institute of Breathing and Sleep |
| Principal Investigator |
| Ian Glaspole | The Alfred | Principal Investigator |
| The Prince Charles Hospital | Recruiting | Brisbane | Queensland | 4032 | Australia |
|
| Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| Austin Health | Recruiting | Melbourne | Victoria | 3084 | Australia |
|
| Derived |
| Glenn LM, Jackson D, Barton C, Lan D, Fuhrmeister L, Symons K, Turnour L, Tefay B, Holland AE, Goh NSL, Troy LK, Brooke M, Glaspole IN, Corte TJ. Usability of a smartphone application for patients with interstitial lung disease: Results from the Registry for Better Understanding of ILD (RE-BUILD) pilot study. Respirology. 2025 Feb;30(2):147-157. doi: 10.1111/resp.14874. Epub 2024 Dec 17. |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D011658 | Pulmonary Fibrosis |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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