Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)
2017年4月8日 更新者：Ernani Tiaraju de Santa Helena、Universidade de Blumenau
Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care.
Its is a pragmatic clinical trial.
研究概览
详细说明
We will study two groups of 198 people with hypertension treated in ten health care units.
One group will receive usual care dispensed in units (control).
The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents.
Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count.
Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths).
The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar).
It will be accepted p value <0.05.
研究类型
介入性
注册 (实际的)
243
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Santa Catarina
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Blumenau、Santa Catarina、巴西
- Family Health Units - Unique Health System
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- persons with hypertension aged 18 years and older
Exclusion Criteria:
- those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
- pregnants
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Control
Usual care.
It means routine medical care that include free demand consultation and free medicines.
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Usual care provided (medical and/or nurse consultation and medicines)
其他名称：
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实验性的：Intervention
Intensification of care.
Besides routine medical care that include free demand consultation and free medicines, subjects were invited to have 6 structured medical encounters based on a social-psychological approach.
Doctors must follow a protocol to conduct the encounter that have around 30 minutes each.
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Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
其他名称：
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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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Change in the proportion of people adherent to treatment - MMAS-8
大体时间：at basal and 3, 6, 9 and 12 months
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It will be measure by "Moriski Medication Adherence Scale 8 item", translated and validated in Brazil.
MMAS scores were trichotomized previously into the following 3 levels of adherence: high adherence (score, 8), medium adherence (score, 6 to <8), and low adherence (score, <6).
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at basal and 3, 6, 9 and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in the proportion of people adherent to treatment - QAM-Q
大体时间：at basal and 3, 6, 9 and 12 months
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It will be measure by "Questionário de Adesão a Medicamentos -Qualiaids" 3 item, an structured questionnaire developed and validated in Brazil.
Non-adherence was accepted if respondent doesn't take 80% of his medicines or if he/she presents any errors on the process (time, jumps..)
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at basal and 3, 6, 9 and 12 months
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Means difference and/or risk ratio between and within groups of clinical outcomes
大体时间：at basal and 3, 6, 9 and 12 months
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It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.
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at basal and 3, 6, 9 and 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ernani S Helena, PhD、Regional University of Blumenau
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2011年3月29日
首先提交符合 QC 标准的
2011年4月7日
首次发布 (估计)
2011年4月8日
研究记录更新
最后更新发布 (实际的)
2017年4月11日
上次提交的符合 QC 标准的更新
2017年4月8日
最后验证
2017年4月1日
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.