None listed
Conditions
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 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
Study design
Eligibility
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