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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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Hypothesis:
Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.
Objectives:
To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence
Specific Aims:
Study Design Rationale:
Qualitative research design and prospective validation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalmine |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data | Participant's adherence behaviour will be measured using a behavioral profile questionnaire, and both the total score, and each individual sub-score, correlated with medication adherence as measured using pharmacy refill rates | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) | Validated measure of reported medication adherence | 12 months |
| Spot Urinary 5-ASA | Urine salicylic acid and 5-ASA levels will be measured in participants |
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Inclusion Criteria:
Exclusion Criteria:
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Patients taking mesalamine for maintenance of remission of ulcerative colitis
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| Name | Affiliation | Role |
|---|---|---|
| Alan 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24913040 | Derived | Moss AC, Lillis Y, Edwards George JB, Choudhry NK, Berg AH, Cheifetz AS, Horowitz G, Leffler DA. Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD. Am J Gastroenterol. 2014 Dec;109(12):1850-5. doi: 10.1038/ajg.2014.158. Epub 2014 Jun 10. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Urine
| 12 months |
| Short Inflammatory Bowel Disease Questionnaire | Validated measure of Quality-of-Life for patients with IBD | 12 months |
| Pharmacy Refill Rates | Mesalamine refill rates will be captured from patiernts' pharmacies | 12 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |