Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
研究概览
简要总结
The purpose of this is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention.
详细描述
The purpose of this study is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention that will include telephone reminders, educational materials, visits to the physician, and financial counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •New or existing diagnosis of inflammatory bowel disease (IBD) proven via endoscopy, pathology, and radiology findings
- •Maintained or started on a medication for inflammatory bowel disease at the time of enrollment
- •Ability to speak English
- •Good hearing
- •Phone availability
排除标准
- •Pregnancy or plans to be pregnant
- •Inability to make own health care decisions
- •Inability to participate in the study phone calls
- •Uncontrolled psychiatric illness
- •Enrollment in another clinical trial outside of the standard clinic IBD registry
研究组 & 干预措施
Health-literacy Assessment
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with low adherence will continue to one or more intervention groups that address needs based on the results of the survey.
Health-literacy Assessment + Education and Reminders
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with then complete a 24-week intervention aimed to improve education about inflammatory bowel disease and scheduled nurse phone call reminders.
干预措施: Education and Reminders (Behavioral)
Health-literacy Assessment + Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.
干预措施: Educational Visit (Behavioral)
Health-literacy Assessment + Medication Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.
干预措施: Medication Educational Visit (Behavioral)
Health-literacy Assessment + Financial Support
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.
干预措施: Financial Support (Behavioral)
结局指标
主要结局
Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
时间窗: 12 Weeks, End of Study (Up to 24 weeks)
MMAS-8 is an 8-item scale that has been validated to measure adherence in IBD patients (scoring details are claimed as proprietary information by the scale's copyright holder).
Change in Medication Possession Ratio (MPR)
时间窗: 12 Weeks, End of Study (Up to 24 weeks)
The Medication possession Rate (MPR) will be calculated as the amount of medication consumed divided by days in the interval and adherence will be defined as greater than 80%.
次要结局
- Change in Harvey Bradshaw Index (HBI) Score(12 Weeks, End of Study (Up to 24 weeks))
- Change in Simple Colitis Activity Index (SCAI) Score(12 Weeks, End of Study (Up to 24 weeks))
- Change in Hospital Anxiety and Depression Scale (HADS) Score(12 Weeks, End of Study (Up to 24 weeks))
- Change in Disease Activity Assessed by the Number of Clinic Visits(12 Weeks, End of Study (Up to 24 weeks))
- Change in Disease Activity Assessed by the Number of Emergency Visits(12 Weeks, End of Study (Up to 24 weeks))
- Change in Disease Activity Assessed by the Number of Surgeries(12 Weeks, End of Study (Up to 24 weeks))
- Change in Disease Activity Assessed by the Number of Admissions(12 Weeks, End of Study (Up to 24 weeks))
- Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score(12 Weeks, End of Study (Up to 24 weeks))
研究者
Heba Iskandar
Assistant Professor
Emory University