An observational study in Ulcerative Colitis and Crohn's Disease, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-19.
Sponsored by Beth Israel Deaconess Medical Center · Observational
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
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 106 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients taking mesalamine for maintenance of remission of ulcerative colitis
Exclusion Criteria:
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
Time frame: 12 months
Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)
Validated measure of reported medication adherence
Time frame: 12 months
Spot Urinary 5-ASA
Urine salicylic acid and 5-ASA levels will be measured in participants
Time frame: 12 months
Short Inflammatory Bowel Disease Questionnaire
Validated measure of Quality-of-Life for patients with IBD
Time frame: 12 months
Pharmacy Refill Rates
Mesalamine refill rates will be captured from patiernts' pharmacies
Time frame: 12 months
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center