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

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01678300
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-05
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation
• must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor
• must be receiving care at Beth Israel Deaconess Medical Center

Exclusion Criteria

• no diagnosis of ulcerative colitis
• no prescription for topical mesalamine
• not receiving care at Beth Israel Deaconess Medical Center

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC	12 months

Secondary Outcome Measures

Name	Time	Method
Clinical outcome (remission / relapse) at 12 months grouped by persistence status	12 months	Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score
Adherence phenotype details	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	12 months	Short Inflammatory Bowel Disease Questionnaire score at 12 months

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States