None listed
Conditions
Brief summary
Inflammatory bowel disease (IBD) is a chronic relapsing and remitting disease that can negatively affect quality of life (QoL) of its sufferers. In terms of IBD management, there are reports of inadequate access to IBD professionals, such as gastroenterologists and IBD nurses, and so there is a need for IBD care to be improved through cost-efficient means. This study aims to test the usability of two smartphone apps, namely IBDsmart and IBDoc, and compare them to usual treatment in terms of IBD-related QoL and IBD symptom scores. IBDsmart is an app for monitoring the clinical symptoms of IBD and IBDoc is an app for measuring the faecal calprotectin (an important biomarker) of IBD patients. The objectives are to see if (a) the information gathered by IBDsmart and IBDoc are sufficient to replace an outpatient appointment, (b) if the apps are acceptable to patients and doctors, and (c) what the impact of the apps is on QoL and IBD symptoms. The participants will be recruited from outpatient clinics in Dunedin, Christchurch, and Auckland from June 2015 to November 2015; they will be randomized to the IBDsmart-IBDoc group or the usual treatment group. It is expected that the smartphone apps (a) will be sufficient to replace an outpatient appointment, (b) will be acceptable to patients and doctors, and (c) will not have a negative impact on QoL or IBD symptoms.
Interventions
The interventions are the IBDsmart and IBDoc smartphone apps. The duration of the intervention is 12 months.
IBDsmart is an app that allows inflammatory bowel disease (IBD) patients to regularly fill in symptom scores and get them sent to their doctor. It is used by the patients by logging in and filling out a questionnaire (Crohn's Disease Activity Index for Crohn's disease and Simple Clinical Colitis Activity Index for ulcerative colitis). When they fill out the questionnaire, a score is pro
The interventions are the IBDsmart and IBDoc smartphone apps. The duration of the intervention is 12 months. IBDsmart is an app that allows inflammatory bowel disease (IBD) patients to regularly fill in symptom scores and get them sent to their doctor. It is used by the patients by logging in and filling out a questionnaire (Crohn's Disease Activity Index for Crohn's disease and Simple Clinical Colitis Activity Index for ulcerative colitis). When they fill out the questionnaire, a score is produced which indicates the severity of the disease. This way long term trends of symptom scores are kept on the smartphone and the health care team can be contacted immediately via the app in cases where disease severity is high. IBDoc is an app that allows IBD patients to measure their faecal calprotectin levels and get their results sent to their doctor. The way the app works is the participant provides a stool sample which is analysed using a medical device which produces an output that can be read via the camera by an app built into IBDoc called CalApp. CalApp communicates with IBDoc which produces a faecal calprotectin score which is high, medium, or low; the level indicates how much physical disease activity is occurring in the patient. These results can also be sent to the healthcare professional team. The use of IBDsmart and IBDoc together allows both clinical and laboratory-based information to be assessed at home by the patient and sent to their medical team. The apps can be used as often as the participants want and can be sent to their medical team at any time. If the patient wishes to report a "flare" they can prompt the app to send the results immediately. The information from the apps will be used to determine if the disease is in remission and if any change in treatment is required. Adherence will be monitored by seeing how often the participants log in and how many scores they send. Participants in the intervention group will be required to use both apps. The other treatment received in the intervention group is normal medical care if and when the disease is determined to be in a "flare."
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed