Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
大体时间：12 months
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical outcome (remission / relapse) at 12 months grouped by persistence status
大体时间：12 months
|
Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score
|
12 months
|
|
Adherence phenotype details
大体时间：12 months
|
|
12 months
|
|
Quality-of-life score at 12 months
大体时间：12 months
|
Short Inflammatory Bowel Disease Questionnaire score at 12 months
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Alan C Moss, MD、Beth Israel Deaconess Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.