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

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ClinicalTrials.gov Identifier: NCT01678300
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center

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

Condition or disease
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 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 : August 2012
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Alan C. Moss, Beth Israel Deaconess Medical Center:
Ulcerative Colitis

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