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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01678300

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this protocol is:

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis

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 Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Outcome Measures

Primary Outcome Measures

Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator: Alan C Moss, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alan C. Moss, Director of Translational Research, Inflammatory Bowel Disease Center, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01678300

Other Study ID Numbers:

2012-P-000100

First Posted:

Sep 5, 2012

Last Update Posted:

Nov 16, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Alan C. Moss, Director of Translational Research, Inflammatory Bowel Disease Center, Beth Israel Deaconess Medical Center

Ulcerative Colitis

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Nov 16, 2015