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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01678300

Enrollment

Registered

2012-09-05

Start date

2012-08-31

Completion date

2015-11-30

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prevalence of non-persistence amongst patients prescribed topical mesalamine for UC	12 months

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results