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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01678300
First received: August 23, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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

Condition
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome (remission / relapse) at 12 months grouped by persistence status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score

  • Adherence phenotype details [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Short Inflammatory Bowel Disease Questionnaire score at 12 months


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT01678300

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: Alan C. Moss, Director of Translational Research, Inflammatory Bowel Disease Center, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01678300     History of Changes
Other Study ID Numbers: 2012-P-000100
Study First Received: August 23, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014