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Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01349504
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : August 19, 2013
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center

Brief Summary:


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

Condition or disease
Ulcerative Colitis Crohn's Disease

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 Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Study Start Date : April 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data [ Time Frame: 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 :
  1. Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) [ Time Frame: 12 months ]
    Validated measure of reported medication adherence

  2. Spot Urinary 5-ASA [ Time Frame: 12 months ]
    Urine salicylic acid and 5-ASA levels will be measured in participants

  3. Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ]
    Validated measure of Quality-of-Life for patients with IBD

  4. Pharmacy Refill Rates [ Time Frame: 12 months ]
    Mesalamine refill rates will be captured from patiernts' pharmacies

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients taking mesalamine for maintenance of remission of ulcerative colitis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349504

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents