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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
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center

April 25, 2011
May 6, 2011
August 19, 2013
April 2011
December 2012   (Final data collection date for primary outcome measure)
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
Adherence to Mesalamine Profile [ Time Frame: 12 months ]
Participant's adherence behaviour will be measured using a behavioral profile questionnaire
Complete list of historical versions of study NCT01349504 on ClinicalTrials.gov Archive Site
  • Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) [ Time Frame: 12 months ]
    Validated measure of reported medication adherence
  • Spot Urinary 5-ASA [ Time Frame: 12 months ]
    Urine salicylic acid and 5-ASA levels will be measured in participants
  • Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ]
    Validated measure of Quality-of-Life for patients with IBD
  • Pharmacy Refill Rates [ Time Frame: 12 months ]
    Mesalamine refill rates will be captured from patiernts' pharmacies
  • Moriskey Medication Adherence Scale (MMAS) 8 [ Time Frame: 12 months ]
    Validated measure of reported medication adherence
  • Urinary 5-ASA [ Time Frame: 12 months ]
    Urine salicylic acid and 5-ASA levels will be measured in participants
  • Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ]
    Validated measure of Quality-of-Life for patients with IBD
  • Pharmacy Refill Rates [ Time Frame: 12 months ]
    Mesalamine refill rates will be captured from patiernts' pharmacies
Not Provided
Not Provided
 
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Urine
Non-Probability Sample
Patients taking mesalamine for maintenance of remission of ulcerative colitis
  • Ulcerative Colitis
  • Crohn's Disease
Not Provided
Mesalmine
Moss AC, Lillis Y, Edwards George JB, Choudhry NK, Berg AH, Cheifetz AS, Horowitz G, Leffler DA. Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD. Am J Gastroenterol. 2014 Dec;109(12):1850-5. doi: 10.1038/ajg.2014.158. Epub 2014 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
100
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01349504
2011-P-000067/1
No
Not Provided
Not Provided
Alan C. Moss, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Shire
Principal Investigator: Alan Moss, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
August 2013