Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
1 other identifier
observational
106
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 19, 2013
August 1, 2013
1.7 years
April 25, 2011
August 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)
12 months
Spot Urinary 5-ASA
12 months
Short Inflammatory Bowel Disease Questionnaire
12 months
Pharmacy Refill Rates
12 months
Study Arms (1)
Mesalmine
Eligibility Criteria
Patients taking mesalamine for maintenance of remission of ulcerative colitis
You may qualify if:
- Adult patient (age \>18)
- 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
You may not qualify if:
- Not receiving primary GI care at BIDMC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Shirecollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 24913040DERIVED
Related Links
Biospecimen
Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Moss, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
April 25, 2011
First Posted
May 6, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 19, 2013
Record last verified: 2013-08