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The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Arm A) | Sham Comparator | Patients randomized to Arm A(control group) will receive an iPhone application without any of the adherence intervention turned on. The control phone application will allow patients to record their medications and how many refills they have remaining. The application will also provide patients with links about their medication. No adherence intervention will be done to these patients. |
|
| Cases (Arm B) | Experimental | Patients randomized to Arm B will receive an iPhone application with the adherence intervention turned on. The study coordinator will help with the installation of the iPhone application. Participants in this group will not need to pay for the iPhone application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPhone Application | Other | All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on. |
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| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence using iPhone App | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
• Are on more than one medication for their inflammatory bowel disease
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Caldera, DO | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |