Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes (FIMDM_CVD)
2014年7月18日 更新者：Duke University
The investigators propose an evaluation that will assess three important components of risk communication:
- provide patients with personalized risk communication using the risk calculator developed by FIMDM and health information taken from the Living with Coronary Artery Disease program
- provide personalized tailored patient feedback to help initiate and maintain specific cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking cessation) to reduce their risks.
- evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.
研究概览
详细说明
Patients at high risk for CVD events frequently underestimate their risk.
Programs to improve CVD outcomes have largely focused on single risk factors and do not contextualize the information with a patient's global risk.
An easy, accessible strategy to address global CVD risk based on personalized risk communication feedback with assistance with initiating and maintaining health behaviors has several advantages, but has not formally been tested.
A patient's perceived risk of stroke or heart attack is an important factor in understanding motivation for risk reducing behaviors.
Lower perceived risk has been associated with poorer adherence to recommended health behaviors.
Additionally, a person's beliefs about his or her risk for a disease increased the likelihood of a more informed and activated patient, and figures prominently in models of health behavior (e.g., Health Belief Model).
People tend to underestimate their own risk; Therefore providing accurate risk communication has the potential to activate patients to initiate and maintain behavior changes.
研究类型
介入性
注册 (实际的)
98
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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North Carolina
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Durham、North Carolina、美国、27705
- Duke University 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 至 90年 (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:
- cardiovascular disease (CVD)
- CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes)
Exclusion Criteria:
- metastatic cancer,
- dementia,
- active psychosis
- end-stage renal disease
- no access to computer with Internet
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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无干预：Control
Receive primary care and management of CVD according to the discretion of their primary care provider.
They will also receive generic educational information concerning CVD at baseline and at study end (at their request).
We will collect outcomes at baseline and 3-months.
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实验性的：Web-based Intervention
Given current risk assessment for CVD based on Health Dialog Cardiac Risk Calculator, recommendations for behavior change, and Health Dialog's Living with Coronary Heart Disease.
Can change initial patient risk information provided by the Risk Calculator during the initial visit, noting what they are will work on during the study.
Sent monthly email reminders to log onto the system to choose that months' behavioral modules.
Given a choice of at least 2 health behavior modules per month (smoking cessation, exercise, diet, and weight) to improve their CVD risk.
Information on risk, CVD knowledge, medication management and side effects will be provided to all participants.
It will also provide tailored information to help the individual initiate and maintain these behaviors.
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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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Cardiovascular Disease (CVD) Risk Knowledge Assessment
大体时间：Baseline and 3 month @ study end
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Trained personnel will obtain the patients' outcome values (i.e., weight, height, BP) at baseline and subsequent 3-month outcome using a digital sphygmomanometer and digital scale according to a standard protocol.
The baseline interview includes demographics and an assessment of patients' health behavior, perceived risk, and interactions with their provider.
At 3-month follow-up visit, patients will also undergo an in-person interview to determine changes in weight, smoking status, medication adherence, decisional conflict, knowledge.
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Baseline and 3 month @ study end
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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：Hayden Bosworth, PhD、Duke University
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12月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2010年5月28日
首先提交符合 QC 标准的
2010年6月1日
首次发布 (估计)
2010年6月2日
研究记录更新
最后更新发布 (估计)
2014年7月22日
上次提交的符合 QC 标准的更新
2014年7月18日
最后验证
2014年7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.
Web-Based Intervention的临床试验
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Luleå Tekniska UniversitetCounty Council of Norrbotten, Sweden未知
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University Hospital, MontpellierUniversity Hospital, Bordeaux完全的
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WepromCentre National de la Recherche Scientifique, France; Kelindi; Hospital of Tours完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人