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

This study has been completed.
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center Identifier:
First received: August 23, 2012
Last updated: November 13, 2015
Last verified: November 2015

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

Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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

  • 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

  • Quality-of-life score at 12 months [ Time Frame: 12 months ]
    Short Inflammatory Bowel Disease Questionnaire score at 12 months

Enrollment: 70
Study Start Date: August 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population of this study will be adults with diagnosed Ulcerative Colitis who have been prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01678300

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Alan C Moss, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Alan C. Moss, Director of Translational Research, Inflammatory Bowel Disease Center, Beth Israel Deaconess Medical Center Identifier: NCT01678300     History of Changes
Other Study ID Numbers: 2012-P-000100
Study First Received: August 23, 2012
Last Updated: November 13, 2015

Keywords provided by Beth Israel Deaconess Medical Center:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 27, 2017