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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678300
• Other study ID #: 2012-P-000100
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: November 13, 2015
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC		12 months	No
Secondary	Clinical outcome (remission / relapse) at 12 months grouped by persistence status	Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score	12 months	No
Secondary	Adherence phenotype details	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	12 months	No
Secondary	Quality-of-life score at 12 months	Short Inflammatory Bowel Disease Questionnaire score at 12 months	12 months	No