Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease|
- Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Validated measure of reported medication adherence
- Spot Urinary 5-ASA [ Time Frame: 12 months ] [ Designated as safety issue: No ]Urine salicylic acid and 5-ASA levels will be measured in participants
- Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]Validated measure of Quality-of-Life for patients with IBD
- Pharmacy Refill Rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mesalamine refill rates will be captured from patiernts' pharmacies
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349504
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Alan Moss, MD||Beth Israel Deaconess Medical Center|