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The purpose of this protocol is:
Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.
The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome (remission / relapse) at 12 months grouped by persistence status | Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score | 12 months |
| Adherence phenotype details |
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Inclusion Criteria:
Exclusion Criteria:
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The population of this study will be adults with diagnosed Ulcerative Colitis who have been prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.
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| Name | Affiliation | Role |
|---|---|---|
| Alan C Moss, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | 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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| 12 months |
| Quality-of-life score at 12 months | Short Inflammatory Bowel Disease Questionnaire score at 12 months | 12 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |