Skip to content

A comparison of disease activity, quality of life and costs following implementation of a digital monitoring strategy in rural patient with inflammatory bowel disease

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001280695
Enrollment
59
Registered
2023-12-08
Start date
2025-05-02
Completion date
2026-01-31
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will compare the impact and acceptability of a digital strategy utilising IBD specific smart phone apps, to standard IBD practice, in the delivery of care to patients from a regional area in Queensland, Australia. We aim to determine the impact of a digital monitoring strategy on quality of life, disease symptoms and costs of care. Participants will be recruited from a regional IBD clinic in Queensland Australia. The trial will run for approximately 15 months. We anticipate that the Implementation of the digital strategy will be non-inferior to standard of care in terms of both patient symptoms and quality of life, whilst reducing health care associated costs.

Interventions

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 asse

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.

Sponsors

Royal Brisbane and Women's Hospital (Inflammatory Bowel Disease Research Funds)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Planned surgical intervention (related to IBD) Ileostomy, colostomy, or ileal pouch-anal anastomosis Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026