A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary Fibrosis self-management package and smartphone application.
- Who it may be relevant to
- Registry conditions: Lung Diseases, Interstitial, Pulmonary Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 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.
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
Primary outcome measures
- Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score [Time frame: Baseline and 12 weeks post-randomisation]
Secondary outcome measures (10)
- Change in K-BILD score [Time frame: 26 and 52 weeks post-randomisation]
- Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score [Time frame: Baseline, 12, 26 and 52 weeks post-randomisation]
- Change in General Self-Efficacy Scale score [Time frame: Baseline, 12, 26, and 52 weeks post-randomisation]
- Change in Dyspnoea-12 score [Time frame: Baseline, 12, 26 and 52 weeks post-randomisation]
- Change in Hospital Anxiety and Depression Scale score [Time frame: Baseline, 12, 26 and 52 weeks post-randomisation]
- Change in physical activity levels [Time frame: Baseline, 12 and 52 weeks post-randomisation]
- Uptake/ changes to ILD treatments [Time frame: Baseline, 12, 26 and 52 weeks post-randomisation]
- Change in mHealth App Usability questionnaire (MAUQ) score [Time frame: 12, 26 and 52 weeks post-randomisation]
- Change in e-Health Literacy (eHEALS) questionnaire score [Time frame: Baseline,12 and 52 weeks post-randomisation]
- Health Care Climate questionnaire [Time frame: 12 weeks post-randomisation]
Eligibility criteria
Inclusion criteria
- 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
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 enrolment
- Acute exacerbation within 30 days prior to enrolment
- Participating in pulmonary rehab at enrolment or during 12-week intervention period
- Unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Australia · 4 centers
- Royal Prince Alfred Hospital — Sydney
- The Prince Charles Hospital — Brisbane
- Alfred Hospital — Melbourne
- Austin Health — Melbourne
Publications
- 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/s12931-025-034 PMID 41350860
- 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. PMID 39689971
Identifiers
NCT: NCT06122233 · X23-0387