Trial Details

Not Recruiting
Basic Information
Clinical ID c2124
Identifier ACTRN12623001280695
Trial 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
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease; Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease;Oral and Gastrointestinal - Inflammatory bowel disease
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 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 calp
Participant Information
Sponsor Royal Brisbane and Women's Hospital (Inflammatory Bowel Disease Research Funds)
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT, TEENAGER
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -