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Completed

NCT Number: NCT01678300

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. 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

  3. Quality-of-life score at 12 months

    Time frame: 12 months

    Short Inflammatory Bowel Disease Questionnaire score at 12 months

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2012
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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