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Trial registered on ANZCTR


Registration number
ACTRN12623001280695p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2023
Date registered
8/12/2023
Date last updated
8/12/2023
Date data sharing statement initially provided
8/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of disease activity, quality of life and costs following implementation of a digital monitoring strategy in rural patient with inflammatory bowel disease
Scientific title
A comparison of disease activity, quality of life and costs following implementation of a digital monitoring strategy using Crohn's Colitis Care (CCCare) versus standard of care among people with inflammatory bowel disease (IBD) from a remote and rural location
Secondary ID [1] 310913 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 331973 0
Ulcerative Colitis 331974 0
Crohn's Disease 331975 0
Condition category
Condition code
Oral and Gastrointestinal 328713 328713 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be offered a digital monitoring strategy. The digital monitoring strategy will utilise two validated smart phone applications, which are integrated into a cloud-based IBD specific electronic medical record (CCCare).

Patient symptoms will be monitored using the IBDSmart app. Within the app, participants with ulcerative colitis, will be asked to fill out the simple clinical colitis activity index (SCCAI) questionnaire, which is a validated tool for assessing the clinical symptoms of ulcerative colitis. The questionnaire asks about bowel frequency, urgency, blood, general well being & extra colonic features. Participants will be able to select the appropriate answer from a checklist. Similarly, patients with Crohn's Disease will be asked to fill out the Harvey-Bradshaw Index (HBI), which is a validated tool for assessing the clinical symptoms of Crohn's Disease. The questionnaire asks about general well being, abdominal pain, number of liquid stools, presence of an abdominal mass, and extra-intestinal symptoms. Participants will be able to select the appropriate answer from a checklist. Each questionnaire will take approximately 2 minutes to fill out and participants will be asked to fill out the questionnaire on entry to the study, at 6 months and 12 months. No strategies will be used to monitor adherence to the intervention.

Participants will be asked to perform a faecal calprotectin test at home, to monitor disease activity. Participants will be asked to extract a faecal sample into a test tube using the stool extraction kit supplied. The stool is then released from the tube into a test cassette. Using the camera the participants Smartphone, the test cassette is scanned and a quantitative result of faecal calprotectin in provided. These data will be automatically relayed to a clinical dashboard within CCCare that will be viewed every weekday by the RBWH IBD team to direct patient care. The faecal calprotectin test is expected to take 2-4 minutes to perform. Participants will be asked to perform the test on entry to the study, at 6 months and 12 months. No strategies will be used to monitor adherence to the intervention.

The Royal Brisbane and Women's Hospital (RBWH) IBD team will communicate with patients via telehealth appointment to direct their care. Appointments will be 30 minutes in duration, and the frequency of communication will be at the discretion of the treating clinician. All participants will be reviewed at least once during the study.
Intervention code [1] 327343 0
Treatment: Other
Comparator / control treatment
Participants in the control arm will receive standard of care. They will be reviewed in a telemedicine clinic (which is the current standard of care for regional/rural patients), alongside pathology and standard laboratory faecal calprotectin. The choice of investigations, and the frequency of follow up appointments will be at the treating clinician's discretion.
Control group
Active

Outcomes
Primary outcome [1] 336516 0
Quality of Life
Timepoint [1] 336516 0
Baseline, 6 months and 12 months post-baseline
Primary outcome [2] 336517 0
Disease symptoms
Timepoint [2] 336517 0
Baseline, 6 months, 12 months post-baseline
Primary outcome [3] 336518 0
Costs
Timepoint [3] 336518 0
Baseline, 6 months, 12 months post-baseline
Secondary outcome [1] 428677 0
Proportion of patients who experience a flare of disease over the course of the trial
Timepoint [1] 428677 0
End of trial (12 months post base-line)
Secondary outcome [2] 428678 0
Patient, nurse & clinician acceptability of the new digital monitoring strategy (intervention arm only)
Timepoint [2] 428678 0
At end of trial (12months post baseline)
Secondary outcome [3] 428679 0
Correlate home faecal calprotectin tests (IBDoc) with standard laboratory ELISA
Timepoint [3] 428679 0
Baseline, 6 months 12 months post-baseline
Secondary outcome [4] 429508 0
Quality of Life (this will be assessed as a primary outcome)
Timepoint [4] 429508 0
Baseline, 6 months & 12 months post-baseline
Secondary outcome [5] 429509 0
Number of IBD-related hospital admissions
Timepoint [5] 429509 0
At end of trial (12months post baseline)
Secondary outcome [6] 429510 0
Number of emergency department visits
Timepoint [6] 429510 0
At end of trial (12months post baseline)
Secondary outcome [7] 429511 0
Number of IBD-related surgeries
Timepoint [7] 429511 0
At end of trial (12months post baseline)
Secondary outcome [8] 429512 0
Need for corticosteroid use during the trial
Timepoint [8] 429512 0
At end of trial (12months post baseline)

Eligibility
Key inclusion criteria
confirmed ulcerative colitis, crohn's disease or IBD-Unspecified
at least 1 outpatient appointment in the last 12 months
willing and able to provide written consent
Greater than or equal to 16 years of age
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned surgical intervention (related to IBD)
Ileostomy, colostomy, or ileal pouch-anal anastomosis
Pregnant

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)
Yes. Central randomisation will be used by computer
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations determined that a sample size of 31 patients with CD per group (n = 62) at follow-up would provide 80% power to detect noninferiority (P < 0.05) using the HBI, assuming an SD of 4.7 and an equivalence limit of 3. In addition, a sample size of 17 patients with UC per group (n = 34) at follow-up would provide 80% power to detect noninferiority (P < 0.05) using the SCCAI, assuming an SD 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 would provide 80% power to detect noninferiority (P < 0.05) using the IBDQ, assuming an SD of 38 and an equivalence limit of 20. Thus, the study will be adequately powered, with a total of 96 participants (62 with CD and 34 with UC) at follow-up.

Mean disease scores and standard deviations will be calculated within disease type (HBI or SCCAI) at each visit. Change from baseline will also be compared within and between groups at each visit. Identical analyses will be used for QoL scores by disease type and for all participants. Comparisons will be made of groups on change from baseline at each visit for disease activity and QoL using a mixed model repeated measures approach, to account for within person correlation.

A cost-utility analysis will be undertaken with the primary analysis from the perspective of the healthcare system. This perspective is the most commonly used economic evaluation method in Australia for policy makers and will allow comparisons across other sectors to identify the relative cost-effectiveness of the intervention for funding proposals. An incremental cost-effectiveness ratio will be calculated following the formula:
ICER = (Costint-Costusual) / (QALYint - QALYusual)

Where int is the new intervention, usual represents usual care and QALY stands for quality adjusted life year. Cost of the intervention will be calculated based on time for the nurse and gastroenterologist to monitor and complete treat-to-target based care. Cost of health care usage will be calculated from iEMR electronic hospital records. Unit costs of care will be derived from appropriate sources for the care. Other costs will be applied at appropriate wage standards for the care provided.

Utility scores will be derived from the EQ-5D-5L using the Australian algorithm. Quality adjusted life years for each group will be calculated using the utility score multiplied by time in the study.

Cost-utility will be modelled using techniques appropriate for clustered data, such as a bivariate GEE (Generalised Estimating Equation) with robust standard errors which can adjust for the clustering and non-normal nature of the data. A final parsimonious model will be selected following data examination and measures of model fit. One-way and probabilistic sensitivity analyses using bootstrapping will be conducted to explore variability in the sampling and population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25813 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 41641 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 315172 0
Other Collaborative groups
Name [1] 315172 0
Statewide Regional Clinical Trials Coordinating Centre (QRCCC)
Country [1] 315172 0
Australia
Funding source category [2] 315173 0
Other Collaborative groups
Name [2] 315173 0
Queensland Teletrials programme
Country [2] 315173 0
Australia
Funding source category [3] 315174 0
Other Collaborative groups
Name [3] 315174 0
Queensland Health Digital Transformation Department
Country [3] 315174 0
Australia
Funding source category [4] 315175 0
Hospital
Name [4] 315175 0
Royal Brisbane and Women's Hospital (Inflammatory Bowel Disease Research Funds)
Country [4] 315175 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital (Inflammatory Bowel Disease Research Funds)
Address
Butterfield Street, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 317191 0
None
Name [1] 317191 0
Address [1] 317191 0
Country [1] 317191 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314105 0
Metro North Health HREC B
Ethics committee address [1] 314105 0
Ethics committee country [1] 314105 0
Australia
Date submitted for ethics approval [1] 314105 0
30/11/2023
Approval date [1] 314105 0
Ethics approval number [1] 314105 0

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

Contacts
Principal investigator
Name 130430 0
Dr Gareth Walker
Address 130430 0
Royal Brisbane and Women's Hospital, Gastroenterology Department, Butterfield Street, Herston, QLD, 4029
Country 130430 0
Australia
Phone 130430 0
+61 736470335
Fax 130430 0
Email 130430 0
gareth.walker@health.qld.gov.au
Contact person for public queries
Name 130431 0
George Tambakis
Address 130431 0
Royal Brisbane and Women's Hospital, Gastroenterology Department, Butterfield Street, Herston, QLD, 4029
Country 130431 0
Australia
Phone 130431 0
+61 736463189
Fax 130431 0
Email 130431 0
george.tambakis@health.qld.gov.au
Contact person for scientific queries
Name 130432 0
George Tambakis
Address 130432 0
Royal Brisbane and Women's Hospital, Gastroenterology Department, Butterfield Street, Herston, QLD, 4029
Country 130432 0
Australia
Phone 130432 0
+61 736463189
Fax 130432 0
Email 130432 0
george.tambakis@health.qld.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20842Study protocol  george.tambakis@health.qld.gov.au 386843-(Uploaded-01-12-2023-07-59-51)-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.