Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000342516
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
15/04/2015
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-inferiority randomised clinical trial of the use of the smartphone-based health applications IBDsmart and IBDoc in the care of inflammatory bowel disease patients in New Zealand.
Scientific title
A non-inferiority randomised clinical trial of the use of the smartphone-based health applications IBDsmart and IBDoc in the care of inflammatory bowel disease patients in New Zealand.
Secondary ID [1] 286411 0
Nil
Universal Trial Number (UTN)
U1111-1168-7172
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 294571 0
Condition category
Condition code
Inflammatory and Immune System 294875 294875 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 294951 294951 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions are the IBDsmart and IBDoc smartphone apps. The duration of the intervention is 12 months.


IBDsmart is an app that allows inflammatory bowel disease (IBD) patients to regularly fill in symptom scores and get them sent to their doctor. It is used by the patients by logging in and filling out a questionnaire (Crohn's Disease Activity Index for Crohn's disease and Simple Clinical Colitis Activity Index for ulcerative colitis). When they fill out the questionnaire, a score is produced which indicates the severity of the disease. This way long term trends of symptom scores are kept on the smartphone and the health care team can be contacted immediately via the app in cases where disease severity is high.

IBDoc is an app that allows IBD patients to measure their faecal calprotectin levels and get their results sent to their doctor. The way the app works is the participant provides a stool sample which is analysed using a medical device which produces an output that can be read via the camera by an app built into IBDoc called CalApp. CalApp communicates with IBDoc which produces a faecal calprotectin score which is high, medium, or low; the level indicates how much physical disease activity is occurring in the patient. These results can also be sent to the healthcare professional team.

The use of IBDsmart and IBDoc together allows both clinical and laboratory-based information to be assessed at home by the patient and sent to their medical team. The apps can be used as often as the participants want and can be sent to their medical team at any time. If the patient wishes to report a "flare" they can prompt the app to send the results immediately. The information from the apps will be used to determine if the disease is in remission and if any change in treatment is required. Adherence will be monitored by seeing how often the participants log in and how many scores they send.

Participants in the intervention group will be required to use both apps. The other treatment received in the intervention group is normal medical care if and when the disease is determined to be in a "flare."
Intervention code [1] 291483 0
Treatment: Other
Comparator / control treatment
Usual outpatient treatment. The usual treatment group will not have access to the smartphone apps. Usual outpatient treatment, for the purposes of this studies, entails the patient seeing their treating gastroenterologist as they usually would.
Control group
Active

Outcomes
Primary outcome [1] 294628 0
Are IBDsmart/IBDoc acceptable to patients and doctors?
(composite)
Doctor completes usability questionnaire for doctors while patient completes usability questionnaire for patients.
Both the doctor and patient questionnaires are a mix of app specific questions about usability but also contain a validated questionnaire called the System Usability Scale (SUS) which produces a number between 0 and 100. SUS is standardized and therefore allows comparisons to be made between apps; it has an industry average of 68.
Timepoint [1] 294628 0
52 weeks post randomisation.
Primary outcome [2] 294629 0
Are IBDsmart/IBDoc non-inferior to standard care delivered through outpatient clinic appointments only?
(Composite)
Inflammatory bowel disease questionnaire is the tool used to measure non-inferiority.
Timepoint [2] 294629 0
52 weeks post randomisation.
Secondary outcome [1] 313753 0
Is the information gathered by IBDsmart/IBDoc sufficient to replace an outpatient appointment?
(Composite)
Doctors and patients asked this directly.
Timepoint [1] 313753 0
52 weeks post randomisation.
Secondary outcome [2] 313754 0
Is IBDsmart/IBDoc equivalent to normal outpatient management in terms of changes in QoL as measured by the inflammatory bowel disease questionnaire (IBDQ) and symptom scores as measured by the DAIs?
Timepoint [2] 313754 0
52 weeks post randomisation.
Secondary outcome [3] 313755 0
What is the impact on disease burden as measured by DAI scores?
Timepoint [3] 313755 0
52 weeks post randomisation.
Secondary outcome [4] 313756 0
How does the CDAI compare with the abbreviated sCDAI (which has no examination or blood test)?
The CDAI and sCDAI are used. The sCDAI only uses patient reported questions whereas the CDAI has a question that is answered medically by a blood test.
Timepoint [4] 313756 0
52 weeks post randomisation.
Secondary outcome [5] 313757 0
How well does IBDoc FC correlate with DAI scores?
The IBDoc FC scores are correlated with the symptom scores (SCCAI for UC and sCDAI for CD)
Timepoint [5] 313757 0
52 weeks post randomisation.
Secondary outcome [6] 313758 0
What is the contribution of the DISQ to the traditional scoring systems?
The Dudley Inflammatory Bowel Symptom Questionnaire (DISQ) is used.
Timepoint [6] 313758 0
52 weeks post randomisation.

Eligibility
Key inclusion criteria
Confirmed UC or CD
At least 2 outpatient appointments in last 12 months.
<3 disease flares in last 12 months
Willing and able to provide written consent
18 years of age or over

18 years of age cutoff lowered to 16 on 15/1/16
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Indeterminate colitis
Severe disease with close monitoring
Possible surgical intervention
Previous surgery
Pregnancy
Unwilling or unable to provide written consent

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)
The participants will be recruited from outpatient clinics in Dunedin, Christchurch, and Auckland from June 2015 to December 2015; they will be randomized to the IBDsmart-IBDoc group or the usual treatment group. Allocation is not concealed

Hutt Valley DHB has been added as a study centre in early 2016.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur by a computer program randomly allocating participants to one of the two groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The data will be managed by the study administrator and all patient information will be partially de-identified. Appropriate descriptive statistics will be provided for all measures of interest. Acceptability of IBDsmart/IBDoc will be evaluated through descriptions of patient and doctor responses. Non-inferiority of the primary outcomes (IBDQ, sCDAI, SCCAI) will be investigated through linear mixed models of the follow-up scores (12, 24, 36, and 52 weeks) adjusting for baseline scores to estimate the difference between usual care and IBDsmart/IBDoc at each time point. The primary outcome, non-inferiority at 52 weeks, will be established where the 90% two-sided CI for the between group effect (usual care-IBDsmart/IBDoc) is strictly above the lower equivalence limits (-20, -70, and -3 respectively). Secondary analyses will be performed similarly using group differences at interim time points. If missing data rates exceed the expected 5% rate, multiple imputation will be used for sensitivity analyses. Correlations between the simple CDAI and full CDAI and between IBDoc FC scores and DAI scores (sCDAI and SCCAI) will be investigated using Pearson’s correlation coefficients. All statistical analyses will be conducted using Stata 13.1 or a later version with tests performed at the 0.05 level (two-sided).
A sample size of 31 patients with Crohn’s Disease (CD) per group (n=62) at follow-up will provide 80% power to detect non-inferiority (p<0.05) using sCDAI assuming a standard deviation of 110 and an equivalence limit of 70. A sample size of 17 patients with Ulcerative Colitis (UC) per group (n=34) at follow-up will similarly provide 80% power to detect non-inferiority (p<0.05) using SCCAI assuming a standard deviation of 3.5 and an equivalence limit of 3.Finally, a sample size of 45 patients with either CD or UC per group (n=90) at follow-up will provide 80% power to detect non-inferiority (p<0.05) using IBDQ assuming a standard deviation of 38 and an equivalence limit of 20.Thus, the study could be adequately powered with a total of 96 participants (62 with CD and 34 with UC) at follow-up. Allowing for 5% loss to follow-up, 102 participants (66 with CD and 36 with UC) will be enrolled at baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
8/08/2015
Date of last participant enrolment
Anticipated
Actual
18/12/2016
Date of last data collection
Anticipated
Actual
18/12/2017
Sample size
Target
102
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 6772 0
New Zealand
State/province [1] 6772 0
Otago
Country [2] 6785 0
New Zealand
State/province [2] 6785 0
Canterbury
Country [3] 6786 0
New Zealand
State/province [3] 6786 0
Waitemata
Country [4] 21114 0
New Zealand
State/province [4] 21114 0
Hutt Valley DHB

Funding & Sponsors
Funding source category [1] 290984 0
Charities/Societies/Foundations
Name [1] 290984 0
Healthcare Otago Charitable Trust
Country [1] 290984 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289664 0
Hospital
Name [1] 289664 0
Southern District Health Board
Address [1] 289664 0
Great King Street, Dunedin, 9016
Country [1] 289664 0
New Zealand
Other collaborator category [1] 280457 0
Hospital
Name [1] 280457 0
Hutt Valley DHB
Address [1] 280457 0
42 Queens Dr, Lower Hutt 5010, New Zealand
Country [1] 280457 0
New Zealand
Other collaborator category [2] 280458 0
Hospital
Name [2] 280458 0
Canterbury DIstrict Health Board
Address [2] 280458 0
2 Riccarton Ave,
Christchurch 8011
Country [2] 280458 0
New Zealand
Other collaborator category [3] 280459 0
Hospital
Name [3] 280459 0
Waitemata DHB
Address [3] 280459 0
124 Shakespeare Rd, Westlake 0622, New Zealand
Country [3] 280459 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292573 0
Health and Disability Ethics Committee
Ethics committee address [1] 292573 0
Ethics committee country [1] 292573 0
New Zealand
Date submitted for ethics approval [1] 292573 0
25/03/2015
Approval date [1] 292573 0
20/05/2015
Ethics approval number [1] 292573 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3197 3197 0 0
/AnzctrAttachments/368243-HDEC Letter 15NTA44_Approved FULL Application with non std conditions.pdf

Contacts
Principal investigator
Name 56030 0
A/Prof Michael Schultz
Address 56030 0
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 56030 0
New Zealand
Phone 56030 0
+64276102395
Fax 56030 0
Email 56030 0
[email protected]
Contact person for public queries
Name 56031 0
Andrew McCombie
Address 56031 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 56031 0
New Zealand
Phone 56031 0
+64272626111
Fax 56031 0
Email 56031 0
[email protected]
Contact person for scientific queries
Name 56032 0
Andrew McCombie
Address 56032 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 56032 0
New Zealand
Phone 56032 0
+64272626111
Fax 56032 0
Email 56032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans to do this as no need


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
572Study protocol    Protocol version 3 368243-(Uploaded-29-11-2018-17-31-43)-Study-related document.docx



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.