An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Treatment adherence at 12 weeks
研究概览
简要总结
In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Written informed consent
- •Male or female patient
- •Age >18 years
- •Previous diagnosis of EoE, confirmed by histopathology, with the presence of >15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies
- •Current maintenance treatment for EoE with a PPI or swallowed topical corticosteroids or about to start with these maintenance medications as decided during regular clinical practice
排除标准
- •Severe and clinically unstable concomitant disease that may interfere with the subject's ability to participate in the study
- •Receive investigational treatment during the study
- •Dilation of esophagus required
- •Insufficient Dutch or English language skills to understand patient information leaflets
结局指标
主要结局
Treatment adherence at 12 weeks
时间窗: 12 weeks
Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate
次要结局
- Differences in self-reported treatment adherence measured by brief-IPQ(12 weeks, 6 months and 12 months.)
- Treatment adherence at 6 months(6 months)
- Treatment adherence at 12 months(12 months)
- Differences in self-reported treatment adherence measured by BMQ(12 weeks, 6 months and 12 months.)
- Differences in self-reported treatment adherence measured by 8-point MMAS(12 weeks, 6 months and 12 months.)
- Differences in self-reported treatment adherence measured by MARS questionnaire(12 weeks, 6 months and 12 months.)
- Change in clinical symptoms measured by DSQ questionnaire(12 weeks, 6 months and 12 months)
- Change in clinical symptoms measured by SDI questionnaire(12 weeks, 6 months and 12 months)
研究者
Prof.dr. A.J. (Arjan) Bredenoord
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)