Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
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Purpose
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 |
|---|
|
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) |
- Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
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 |
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| Contact: Alan C Moss, MD | 617-667-3197 | |
| Contact: Anne E Gifford, MPH | 617-667-0558 |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Alan C Moss, MD 617-667-3197 | |
| Contact: Anne E Gifford, MPH 617-667-0558 | |
| 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: | August 30, 2012 |
| 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 June 18, 2013