Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT01349504|
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : August 19, 2013
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.
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
|Condition or disease|
|Ulcerative Colitis Crohn's Disease|
- To test a novel interview instrument to classify patients into "adherence profiles"
- To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
|Study Type :||Observational|
|Actual Enrollment :||106 participants|
|Official Title:||Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data [ Time Frame: 12 months ]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
- Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) [ Time Frame: 12 months ]Validated measure of reported medication adherence
- Spot Urinary 5-ASA [ Time Frame: 12 months ]Urine salicylic acid and 5-ASA levels will be measured in participants
- Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ]Validated measure of Quality-of-Life for patients with IBD
- Pharmacy Refill Rates [ Time Frame: 12 months ]Mesalamine refill rates will be captured from patiernts' pharmacies
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349504
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Alan Moss, MD||Beth Israel Deaconess Medical Center|