Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.
Detailed description
Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-adherence in patients in clinical remission is high with rates around 60%. Non adherence in patients in clinical remission can have significant impact because it can lead to higher rates of clinical flares and increased health care cost. This will be a single-blinded randomized controlled trial to evaluate if patients randomized to an iPphone application vs. control can increase the adherence of their maintenance medication. The trial will last three months and we hope to enroll 99 patients. The primary outcome will be adherence measured by the medication possession ratio. The secondary objective will be to evaluate if a validated adherence questionnaire can predict adherence in patients with inflammatory bowel disease. Having an intervention that can increase adherence can provide better care for patients. Also having a validated survey tool can accurately identify non-adherence in inflammatory bowel disease patient would be a valuable tool for patient care.
Interventions
OTHERiPhone Application
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* At least 18 -65 years of age. * Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology. * On a stable dose of mesalamine for at least two months prior to entering the study * Have an iPhone (personal iPhone) * Patient may receive steroid or mesalamine enemas during the study only on an as needed basis
Exclusion criteria
• Are on more than one medication for their inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication adherence using iPhone App | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ) | 3 months |
Countries
United States
Outcome results
None listed