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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122233
• Other study ID #: X23-0387
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2027

Study information

• Verified date: May 2024
• Source: University of Sydney
• Contact: Carly Barton
• Phone: +61 2 9515 5682
• Email: Carly.Barton[@]Sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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 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 through the phone calls and the number of times links and various screens accessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 planning to participate during 12-week intervention period

• Unable to provide informed consent

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

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 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.

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Austin Health	Melbourne	Victoria
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
University of Sydney	Lung Foundation Australia, Monash University, University of Tasmania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	K-BILD	As above	26 and 52 weeks post-randomisation
Secondary	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
Secondary	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
Secondary	Dyspnoea-12	Score range 0-36; higher score corresponding to greater level of dyspnoea	Baseline, 12, 26 and 52 weeks post-randomisation
Secondary	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
Secondary	Physical activity levels (STEPWatch - physical activity monitor)	Number of steps/day at beginning of intervention vs. end of intervention and end of follow-up period	Baseline, 12 and 52 weeks post-randomisation
Secondary	Uptake/changes to ILD treatments	Whether participant commenced a new or modified an existing ILD treatment	Baseline, 12, 26 and 52 weeks post-randomisation
Secondary	mHealth Usability questionnaire	Score range 18-126; higher score indicating greater satisfaction with the RE-BUILD app	26 and 52 weeks post-randomisation
Secondary	E-Health Literacy questionnaire	Score range 8-40; higher score indicating higher degree of perceived e-health literacy	Baseline,12 and 52 weeks post-randomisation
Secondary	Health Care Climate questionnaire	Score range 6-42; higher score indicating greater satisfaction with treating team	12 weeks post-randomisation