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.
Not Applicable
Completed
- Conditions
- Inflammatory bowel diseaseInflammatory and Immune System - Other inflammatory or immune system disordersOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12615000342516
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 107
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
Exclusion Criteria
Indeterminate colitis
Severe disease with close monitoring
Possible surgical intervention
Previous surgery
Pregnancy
Unwilling or unable to provide written consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Are IBDsmart/IBDoc acceptable to patients and doctors?<br>(composite)<br>Doctor completes usability questionnaire for doctors while patient completes usability questionnaire for patients.<br>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.[52 weeks post randomisation.];Are IBDsmart/IBDoc non-inferior to standard care delivered through outpatient clinic appointments only?<br>(Composite)<br>Inflammatory bowel disease questionnaire is the tool used to measure non-inferiority.[52 weeks post randomisation.]
- Secondary Outcome Measures
Name Time Method