Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000385549
Ethics application status
Approved
Date submitted
7/03/2024
Date registered
3/04/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating smartphone tracking apps for people with Irritable Bowel Syndrome
Scientific title
Investigating smartphone tracking apps for people with Irritable Bowel Syndrome
Secondary ID [1] 311689 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 333150 0
Condition category
Condition code
Oral and Gastrointestinal 329848 329848 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of this study is the use of a symptom tracking app. In particular the study will use the Eat Smart Kiwi app which is available on the Apple and Android app stores. There will be two intervention groups that differ in terms of dose effect. One group will be asked to track a large list of symptoms including common symptoms like headache and fatigue. The second group will only be asked to track symptoms relevant to irritable bowel syndrome like stomach pain. Tracking symptoms involves rating the symptom on a scale from great - 0 to awful -10. The time at which they make this rating is recorded or they can adjust this to reflect the time at which they are making the rating for. The app has options to set up to three reminders per day (9am, 1pm, 7pm) we will make participants aware of this feature but not require them to use a reminder. All groups will be asked to use the app for four weeks. In addition to symptom tracking the app has features to track diet, sleep, mood and bowel movements. We will encourage them to use the diet tracking feature to fit with the trial's cover story. Food tracking involves setting the time of eating and listing the different foods eaten. The app does not support calorie tracking, just noting the food itself. There will be no requirement to use any of the other features. We will monitor adherence by extracting data regarding the number of times the app was opened within the four week period. We will not access any of the data input to the app regarding symptoms or food.
Intervention code [1] 328150 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will also download the Eat Smart Kiwi app and use it for one month. However the symptom tracking function of the app will be disabled.
Control group
Active

Outcomes
Primary outcome [1] 337617 0
Symptom reporting
Timepoint [1] 337617 0
Baseline, two weeks, four weeks, six months post end of app usage period
Secondary outcome [1] 432537 0
Gastrointestinal symptom-specific anxiety
Timepoint [1] 432537 0
baseline, two weeks, four weeks and six months post end of app usage period
Secondary outcome [2] 433117 0
general anxiety
Timepoint [2] 433117 0
Baseline, two weeks, four weeks and six months post end of app usage period

Eligibility
Key inclusion criteria
Participants must either have a diagnosis of Irritable Bowel Syndrome (IBS) or meet the Rome IV criteria for an IBS diagnosis.

Additionally participants must have a smartphone and be able to read and write in English.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People unwilling to use a food tracking app for four weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to one of three groups automatically by computer when they complete the screening questionnaire.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
30/04/2024
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
10/02/2025
Actual
Sample size
Target
140
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26191 0
New Zealand
State/province [1] 26191 0

Funding & Sponsors
Funding source category [1] 316017 0
University
Name [1] 316017 0
University of Auckland
Country [1] 316017 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora
Address
Country
New Zealand
Secondary sponsor category [1] 318169 0
None
Name [1] 318169 0
Address [1] 318169 0
Country [1] 318169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314840 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314840 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 314840 0
New Zealand
Date submitted for ethics approval [1] 314840 0
28/03/2024
Approval date [1] 314840 0
26/04/2024
Ethics approval number [1] 314840 0
2024 EXP 19213

Summary
Brief summary
This study intends to understand the effects of symptom tracking apps on symptom reporting for people with IBS. Participants will be allocated to use one of three versions of a smartphone tracking app that differs in terms of the degree of symptom reporting for four weeks. We expect that those asked to track more symptoms by the app may end up reporting experiencing more symptoms at the end of four weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132890 0
Dr Kate MacKrill
Address 132890 0
University of Auckland, 85 Park Road, Grafton, Auckland 1023
Country 132890 0
New Zealand
Phone 132890 0
+64 0212878834
Fax 132890 0
Email 132890 0
Kate.mackrill@middlemore.co.nz
Contact person for public queries
Name 132891 0
Grace Lyon
Address 132891 0
University of Auckland, 85 Park Road, Grafton, Auckland 1023
Country 132891 0
New Zealand
Phone 132891 0
+64210756024
Fax 132891 0
Email 132891 0
glyo697@aucklanduni.ac.nz
Contact person for scientific queries
Name 132892 0
Grace Lyon
Address 132892 0
University of Auckland, 85 Park Road, Grafton, Auckland 1023
Country 132892 0
New Zealand
Phone 132892 0
+64210756024
Fax 132892 0
Email 132892 0
glyo697@aucklanduni.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.