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
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:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014