Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor (TRUST)
Influence of Participation in Randomized Controlled Trials on Cardiovascular Patient's Adherence to Medicines' Intake and regUlar viSits to the docTor
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Moscow、俄罗斯联邦、101990
- National Research Center for Preventive Medicine
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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 criterion for study group
• All patients of the outpatient register PROFILE who participated in the international randomized clinical trials from 2011 to 2018, (n≈100).
Inclusion criterion for control group
• Patients of the outpatient register PROFILE, who from 2011 to 2018 were observed in the research center for preventive medicine and never participated in international randomized clinical trials (n≈100).
Exclusion criteria for both groups
- Patients whose life status is defined as "dead"
- Patients who refused to participate in our study
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：横截面
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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study group
Patients who have been participated in RCT in the period from 2011 to 2018 (study group)
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不提供
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control group
- Patients who have never participated in RCT
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不提供
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of motives of enrollment in a trial and patient's attitude to RCT based on elaborated questionnaires for both groups
大体时间：on enrollment
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The specially designed questionnaire for the study group includes 9 questions. Based on the data obtained, we will be able to draw conclusions about the motives for participating in RCTs, the level of trust towards a doctor, and adherence to treatment after the end of the RCT. The questionnaire for the control group includes 8 questions with 3 possible answers as well. Based on the data obtained, we will determine the level of patient awareness of RCTs and the willingness to participate in the trial in the future. This questionnaire is exploratory, each question is considered individually, which allows us to make a more detailed analysis of various aspects of our study. |
on enrollment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TRUST
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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