Tailored Approaches to Stroke Health Education (TASHE)
2020年7月13日 更新者：Olajide Williams、Columbia University
The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team.
Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC).
Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.
研究概览
详细说明
Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion annually.
Interventions designed to educate patients to seek treatment sooner when a stroke occurs may increase low rates of treatment with thrombolysis (current rates 3% national average).
Thrombolysis can increase the odds of minimal to zero disability from stroke if emergency medical system response times and in-hospital response times are optimized (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours).
Black and Hispanic Americans have higher stroke incidence compared to Whites and are less likely to receive thrombolysis for acute stroke.
The latency to hospital arrival is largely dependent on patients' recognition of stroke symptoms, and immediate presentation to the emergency department.
The investigators have found very low stroke literacy rates among Blacks and Hispanics compared to Whites, which may, in part, be responsible for disparities in acute stroke treatment.
研究类型
介入性
注册 (实际的)
290
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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New York
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New York、New York、美国、10032
- Columbia University Medical Center
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New York、New York、美国、10032
- Columbia University Medical Center, Neurological Institute
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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
34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:
- No prior history of stroke;
- High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
- Over age 34 years at onset of intervention (we have selected this age cut off due to the large increase in stroke incidence among minority groups at age 34 );
- Self-identified as Black or Hispanic; and
- Member of a church congregation who lives in a household with a telephone.
Exclusion Criteria:
- Participant is unable to give consent;
- A modified Rankin score > 4 at baseline;
- history of dementia; and
- terminal illness, or other medical illness resulting in mortality < 1 year.
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention Group
Participants will receive education through a novel program called Stroke Education Film Viewing.
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A novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-min films (in English and Spanish), in minority populations in New York City.
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其他：Usual Care Group
Participants will receive education through Stroke Education Pamphlet Exposure.
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"Usual Care": Stroke Education pamphlet and brochure distribution.
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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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Score on Stroke Action Test
大体时间：Within one hour of stroke education intervention.
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The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
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Within one hour of stroke education intervention.
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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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Score on Stroke Action Test
大体时间：Within six months of stroke education intervention.
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The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
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Within six months of stroke education intervention.
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Score on Stroke Action Test
大体时间：Within one year of stroke education intervention.
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The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
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Within one year of stroke education intervention.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to emergency room after suffering a stroke
大体时间：Up to 3.5 years post-intervention
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This measures the time in getting to the emergency room after having suffered a stroke.
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Up to 3.5 years post-intervention
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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：Olajide. A Williams, MD, MS、Columbia University
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。
一般刊物
- Williams O, Teresi J, Eimicke JP, Abel-Bey A, Hassankhani M, Valdez L, Gomez Chan L, Kong J, Ramirez M, Ravenell J, Ogedegbe G, Noble JM. Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1211-1218. doi: 10.1001/jamaneurol.2019.1741.
- Ravenell J, Leighton-Herrmann E, Abel-Bey A, DeSorbo A, Teresi J, Valdez L, Gordillo M, Gerin W, Hecht M, Ramirez M, Noble J, Cohn E, Jean-Louis G, Spruill T, Waddy S, Ogedegbe G, Williams O. Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial. Trials. 2015 Apr 19;16:176. doi: 10.1186/s13063-015-0703-4.
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 (实际的)
2014年4月16日
初级完成 (实际的)
2017年6月8日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2013年7月22日
首先提交符合 QC 标准的
2013年7月24日
首次发布 (估计)
2013年7月26日
研究记录更新
最后更新发布 (实际的)
2020年7月15日
上次提交的符合 QC 标准的更新
2020年7月13日
最后验证
2020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.