Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data
研究概览
简要总结
Hypothesis:
Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.
Objectives:
To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence
详细描述
Specific Aims:
- To test a novel interview instrument to classify patients into "adherence profiles"
- To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age >18)
- •Diagnosis of IBD (confirmed by endoscopy and histology) > 3 months
- •In clinical remission (based on Simple Colitis Activity Index score <2.5)
- •On mesalamine compound for maintenance of remission
- •Stable mesalamine dose for 1 month
排除标准
- •Not receiving primary GI care at BIDMC
结局指标
主要结局
Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data
时间窗: 12 months
Participant's adherence behaviour will be measured using a behavioral profile questionnaire, and both the total score, and each individual sub-score, correlated with medication adherence as measured using pharmacy refill rates
次要结局
- Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)(12 months)
- Pharmacy Refill Rates(12 months)
- Spot Urinary 5-ASA(12 months)
- Short Inflammatory Bowel Disease Questionnaire(12 months)
研究者
Alan C. Moss
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center