Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349504
• Other study ID #: 2011-P-000067/1
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: August 16, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)	Validated measure of reported medication adherence	12 months	No
Secondary	Spot Urinary 5-ASA	Urine salicylic acid and 5-ASA levels will be measured in participants	12 months	No
Secondary	Short Inflammatory Bowel Disease Questionnaire	Validated measure of Quality-of-Life for patients with IBD	12 months	No
Secondary	Pharmacy Refill Rates	Mesalamine refill rates will be captured from patiernts' pharmacies	12 months	No

External Links

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