Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01349504
First received: April 25, 2011
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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


Condition
Ulcerative Colitis
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

Urine


Enrollment: 106
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients taking mesalamine for maintenance of remission of ulcerative colitis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349504

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Shire
Investigators
Principal Investigator: Alan Moss, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alan C. Moss, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01349504     History of Changes
Other Study ID Numbers: 2011-P-000067/1
Study First Received: April 25, 2011
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases

ClinicalTrials.gov processed this record on October 01, 2014