Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000883415
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
13/08/2025
Date last updated
13/08/2025
Date data sharing statement initially provided
13/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a mobile app on healthcare navigation stress and communication satisfaction in people living with Inflammatory Bowel Disease.
Scientific title
Evaluation of consumer navigation stress and communication satisfaction and the impact of a novel digital phone application in patients with inflammatory bowel disease patients.
Secondary ID [1] 313945 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 336650 0
Condition category
Condition code
Inflammatory and Immune System 333146 333146 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consumers (patients with inflammatory bowel disease) will complete baseline evaluation surveys to measure consumer navigation stress and communication satisfaction. Patients with IBD will be provided with an IBD-centric phone application ("Crohn's Colitis Navigator") as an adjunct to routine clinical care for their IBD.

Study type: Interventional. The mobile application will be rolled out for use in all healthcare sites already enrolled in the Crohn's Colitis Care electronic medical record system. Patients who decline to participate will not be included in the research (i.e. no medical record access) and any data generated from the app will not be used in the research.

Location: To be delivered remotely/online (apart from potential in person recruitment from clinical settings).

Number of times: N/A - to be used throughout the period of the study. No specification of number of times the app needs to be used. App analytics and engagement will be monitored in a de-identified manner as a cohort.

Duration: 24 months (12 months control recruitment prior to app implementation, 12 months post app implementation)

Intervention: Use of an IBD-centric phone application (symptom tracker, communication tool with the healthcare team, curated information resources, personalised medical information from personal electronic medical records - via CCCare, administrative tool e.g. medication and appointment reminders)

Additional information:
1. All patients will be offered information about how to download the application and incorporated into their 'routine care' as an adjunct, irrespective of participation in the study.
2. No specific instruction about how they 'need' to use the application, it will be an adjunct whether they use its once a day, once a year etc.
Intervention code [1] 330535 0
Other interventions
Comparator / control treatment
Before and after design.

Control group - patients with IBD enrolled prior to app usage/implementation.
One off baseline surveys to determine "healthcare navigation stress" and "communication satisfaction". Next follow up to be after period of app usage.
Control group
Active

Outcomes
Primary outcome [1] 340714 0
Consumer navigation stress
Timepoint [1] 340714 0
Baseline (at the time of recruitment), 12 months post-intervention (app roll out)
Primary outcome [2] 340715 0
Satisfaction with clinician communication
Timepoint [2] 340715 0
Baseline (at the time of recruitment), 12 months post-intervention (app roll out)
Secondary outcome [1] 444853 0
Healthcare utilisation
Timepoint [1] 444853 0
Baseline (at the time of recruitment), 12 months post-intervention (app roll out)

Eligibility
Key inclusion criteria
Patients with inflammatory bowel disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to complete surveys sufficiently

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2025
Actual
Date of last participant enrolment
Anticipated
28/08/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26875 0
New Zealand
State/province [1] 26875 0

Funding & Sponsors
Funding source category [1] 318439 0
Charities/Societies/Foundations
Name [1] 318439 0
Helmsley Charitable Trust
Country [1] 318439 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Crohn's Colitis Cure
Address
Country
Australia
Secondary sponsor category [1] 320834 0
None
Name [1] 320834 0
Address [1] 320834 0
Country [1] 320834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317057 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317057 0
Ethics committee country [1] 317057 0
Australia
Date submitted for ethics approval [1] 317057 0
25/03/2025
Approval date [1] 317057 0
11/04/2025
Ethics approval number [1] 317057 0
2025-02-192

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139854 0
Prof Jane Andrews
Address 139854 0
Crohn's Colitis Cure, Level 3, 100 Harris St, Pyrmont NSW 2009
Country 139854 0
Australia
Phone 139854 0
+61415751119
Fax 139854 0
Email 139854 0
[email protected]
Contact person for public queries
Name 139855 0
Patrick Chan
Address 139855 0
Crohn's Colitis Cure, Level 3, 100 Harris St, Pyrmont NSW 2009
Country 139855 0
Australia
Phone 139855 0
+61432977114
Fax 139855 0
Email 139855 0
[email protected]
Contact person for scientific queries
Name 139856 0
Patrick Chan
Address 139856 0
Crohn's Colitis Cure, Level 3, 100 Harris St, Pyrmont NSW 2009
Country 139856 0
Australia
Phone 139856 0
+61432977114
Fax 139856 0
Email 139856 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.