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OpenTrials
Completed

NCT Number: NCT01349504

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

Specific Aims:

  • To test a novel interview instrument to classify patients into "adherence profiles"
  • To validate this instrument with quantitative scores of mesalamine adherence and objective testing.

Study Design Rationale:

Qualitative research design and prospective validation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Shire

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 6, 2011
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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