Clinical Trial: Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Brief Summary:

The purpose of this protocol is:

  1. To quantify the prevalence of adherence to topical mesalamine in patients with UC
  2. To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine

Detailed Summary:

Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.

The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.


Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical outcome (remission / relapse) at 12 months grouped by persistence status [ Time Frame: 12 months ]
    Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score
  • Adherence phenotype details [ Time Frame: 12 months ]
    • Prevalence of self-reported "low adherence" amongst patients prescribed topical mesalamine
    • Demographic and disease phenotype variables associated with "non persistence" or "low adherence" using multivariate logistic regression analysis
  • Quality-of-life score at 12 months [ Time Frame: 12 months ]
    Short Inflammatory Bowel Disease Questionnaire score at 12 months


Original Secondary Outcome: Same as current

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: August 23, 2012
Date Started: August 2012
Date Completion:
Last Updated: November 13, 2015
Last Verified: November 2015