Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease

• Registration Number: NCT01349504
• Lead Sponsor: Beth Israel Deaconess Medical Center

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

Detailed Description

Specific Aims:

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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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

Exclusion Criteria

• Not receiving primary GI care at BIDMC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data	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

Secondary Outcome Measures

Name	Time	Method
Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)	12 months	Validated measure of reported medication adherence
Pharmacy Refill Rates	12 months	Mesalamine refill rates will be captured from patiernts' pharmacies
Spot Urinary 5-ASA	12 months	Urine salicylic acid and 5-ASA levels will be measured in participants
Short Inflammatory Bowel Disease Questionnaire	12 months	Validated measure of Quality-of-Life for patients with IBD

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States