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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06122233




Registration number
NCT06122233
Ethics application status
Date submitted
2/11/2023
Date registered
8/11/2023

Titles & IDs
Public title
A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
Scientific title
A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease
Secondary ID [1] 0 0
X23-0387
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial 0 0
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Pulmonary Fibrosis self-management package and smartphone application

Experimental: REBUILD-SM Group - 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.

No intervention: Standard Care Group - 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.


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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in King's Brief Interstitial Lung Disease (K-BILD) questionnaire score
Assessment method [1] 0 0
Score range 0 - 100; higher score corresponding to better outcome.
Timepoint [1] 0 0
Baseline and 12 weeks post-randomisation
Secondary outcome [1] 0 0
Change in K-BILD score
Assessment method [1] 0 0
As above
Timepoint [1] 0 0
26 and 52 weeks post-randomisation
Secondary outcome [2] 0 0
Change in European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire score
Assessment method [2] 0 0
Score range 11111 - 55555; 0-100; higher score indicating worse outcome
Timepoint [2] 0 0
Baseline, 12, 26 and 52 weeks post-randomisation
Secondary outcome [3] 0 0
Change in General Self-Efficacy Scale score
Assessment method [3] 0 0
Score range 10 - 40; higher score indicating low level of perceived self-efficacy
Timepoint [3] 0 0
Baseline, 12, 26, and 52 weeks post-randomisation
Secondary outcome [4] 0 0
Change in Dyspnoea-12 score
Assessment method [4] 0 0
Score range 0-36; higher score corresponding to greater level of dyspnoea
Timepoint [4] 0 0
Baseline, 12, 26 and 52 weeks post-randomisation
Secondary outcome [5] 0 0
Change in Hospital Anxiety and Depression Scale score
Assessment method [5] 0 0
Score range 0-21 (for anxiety and depression); higher scores corresponding to severe anxiety and/or depression
Timepoint [5] 0 0
Baseline, 12, 26 and 52 weeks post-randomisation
Secondary outcome [6] 0 0
Change in physical activity levels
Assessment method [6] 0 0
Change in steps per day and change in time spent in the four intensity categories (inactive, low, medium and high activity) will be measured using a physical activity monitor
Timepoint [6] 0 0
Baseline, 12 and 52 weeks post-randomisation
Secondary outcome [7] 0 0
Uptake/ changes to ILD treatments
Assessment method [7] 0 0
Includes changes to medications, commencement or change in supplemental oxygen use, participation in pulmonary rehab
Timepoint [7] 0 0
Baseline, 12, 26 and 52 weeks post-randomisation
Secondary outcome [8] 0 0
Change in mHealth App Usability questionnaire (MAUQ) score
Assessment method [8] 0 0
Score range 18-126; higher score indicating greater satisfaction with the REBUILD app
Timepoint [8] 0 0
12, 26 and 52 weeks post-randomisation
Secondary outcome [9] 0 0
Change in e-Health Literacy (eHEALS) questionnaire score
Assessment method [9] 0 0
Score range 8-40; higher score indicating higher degree of perceived e-health literacy
Timepoint [9] 0 0
Baseline,12 and 52 weeks post-randomisation
Secondary outcome [10] 0 0
Health Care Climate questionnaire
Assessment method [10] 0 0
Score range 6-42; higher score indicating greater satisfaction with treating team
Timepoint [10] 0 0
12 weeks post-randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Lung Foundation Australia
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Tasmania
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Tamera Corte
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carly Barton
Address 0 0
Country 0 0
Phone 0 0
+61 2 9515 5682
Email 0 0
Carly.Barton@Sydney.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06122233