Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
NCT ID: NCT01349504
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
106 participants
OBSERVATIONAL
2011-04-30
2012-12-31
Brief Summary
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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
Detailed Description
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1. To test a novel interview instrument to classify patients into "adherence profiles"
2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mesalmine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of IBD (confirmed by endoscopy and histology) \> 3 months
* In clinical remission (based on Simple Colitis Activity Index score \<2.5)
* On mesalamine compound for maintenance of remission
* Stable mesalamine dose for 1 month
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Alan C. Moss
Assistant Professor of Medicine
Principal Investigators
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Alan Moss, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
Related Links
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Other Identifiers
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2011-P-000067/1
Identifier Type: -
Identifier Source: org_study_id