Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •no diagnosis of ulcerative colitis
- •no prescription for topical mesalamine
- •not receiving care at Beth Israel Deaconess Medical Center
结局指标
主要结局
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
时间窗: 12 months
次要结局
- Clinical outcome (remission / relapse) at 12 months grouped by persistence status(12 months)
- Adherence phenotype details(12 months)
- Quality-of-life score at 12 months(12 months)
研究者
Alan C. Moss
Director of Translational Research, Inflammatory Bowel Disease Center
Beth Israel Deaconess Medical Center