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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 1 of 10 entries
    • Study description shortened, about 13 words
    • Study title expanded, about 6 words
    • Eligibility criteria shortened, about 3 words
    v6
  2. Primary endpoint revised
    • Secondary endpoints revised (10)
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Jun 3, 2024
    • Site details revised at 4 of 4 sites
    v4
  4. Start date: Mar 2024 to May 2024
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints revised (10)
    • Study description shortened, about 16 words
    v3
  5. Secondary endpoints revised (10)
    • Study description revised
    • Site contacts updated at 1 of 4 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06122233
Lead Sponsor University of Sydney
Collaborators: Monash University, Lung Foundation Australia, University of Tasmania
Conditions
(from sponsor)		 Lung Diseases, Interstitial, Pulmonary Fibrosis
Related terms Chronic Disease, Lung Diseases, Interstitial, Pulmonary Fibrosis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov