NCT06122233|RecruitingDMC
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Sponsor study identifier
interventional
400
1 country
4
Study Start
June 3, 2024
Actual (reported)Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2023
Actual (reported)November 8, 2023
Actual (reported)June 3, 2024
Actual (reported)June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
The Prince Charles Hospital
Brisbane, Queensland, 4032, Australia
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.
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.
Tamera Corte
University of Sydney
Dan Chambers
The University of Queensland
Nicole Goh
Institute of Breathing and Sleep
Ian Glaspole
The Alfred
First Submitted
November 2, 2023
First Posted
November 8, 2023
Study Start
June 3, 2024
Actual (reported)Interstitial Lung Disease Exacerbations Study
Contact the study team to confirm eligibility.
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Austin Health
Melbourne, Victoria, 3084, Australia
Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 4, 2025
Record last verified: 2025-04
Deidentified data will be placed in a secure repository for future analysis.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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