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

NCT06122233 | Recruiting DMC

• 1 other identifier: X23-0387
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Keywords

Self-Management; Chronic diseases

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in K-BILD score

  26 and 52 weeks post-randomisation

• Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score

  Baseline, 12, 26 and 52 weeks post-randomisation

• Change in General Self-Efficacy Scale score

  Baseline, 12, 26, and 52 weeks post-randomisation

• Change in Dyspnoea-12 score

  Baseline, 12, 26 and 52 weeks post-randomisation

• Change in Hospital Anxiety and Depression Scale score

  Baseline, 12, 26 and 52 weeks post-randomisation

Study Arms (2)

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.

Behavioral: Pulmonary Fibrosis self-management package and smartphone application

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.

Interventions

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.

Also known as: REBUILD-SM

REBUILD-SM Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead
• Monash University: collaborator
• Lung Foundation Australia: collaborator
• University of Tasmania: collaborator

Study Sites (4)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 41350860 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis; Chronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Barton

CONTACT

+61 2 9515 5682; Carly.Barton@Sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: June 3, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available at the end of the trial (approx. April 2028).
• Access Criteria: Requires ethical approval

Locations

AU (4)