Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
2018年6月2日 更新者：Barbara Vickrey, MD, MPH、University of California, Los Angeles
RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.
研究概览
详细说明
Patients randomized to SUSTAIN will participate in group clinics about stroke, given self-management tools about stroke, and will be called by nurse practitioners to coordinate their stroke care.
Patients randomized to the control arm will be mailed educational materials about stroke.
Subjects in either arm are eligible to receive their usual source of care.
研究类型
介入性
注册 (实际的)
410
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
-
-
California
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Downey、California、美国、90242
- Rancho Los Amigos National Rehabilitation Center
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Los Angeles、California、美国、90024
- UCLA
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Los Angeles、California、美国、90033
- LAC+USC Medical Center
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Sylmar、California、美国、91342
- Olive View-UCLA Medical Center
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Torrance、California、美国、90502
- Harbor-UCLA Medical Center
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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
40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:
- Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA
- Patients who have had an acute transient ischemic attack (TIA) or ischemic stroke or carotid procedure within the last six months
- English or Spanish speaking
- At least 40 years of age
- Capable of giving informed consent (no proxies will be used to obtain consent)
- Blood pressure not optimally controlled (>120/80, at least 72 hours post-stroke)
Exclusion Criteria:
- Age 39 years or younger
- Hemorrhagic stroke
- Patients with severe global disability which would preclude him/her from participating in group clinics
- Patients with advanced dementia
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：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：1: Care management
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Over a period of one year, subjects will participate in two regular stroke clinics, three group clinics, obtain self-management tools, and will receive a series of four scheduled telephone calls by nurse practitioners to review information delivered during the group clinics and help with care coordination.
Usual care will also be available.
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有源比较器：2: Written Materials
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Educational materials about stroke that will be distributed during the group clinic session will be mailed to these subjects.
These materials have been developed by the American Heart Association.
Usual care will also be available.
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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 |
|---|---|---|
|
Blood Pressure
大体时间：12 months
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Blood pressure at 12 months will be the primary outcome.
Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
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12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lipid levels
大体时间：12 month
|
LDL, HDL, triglycerides and total cholesterol will be measured at 12-months.
The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
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12 month
|
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Medication Adherence
大体时间：8 months
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Medication adherence will be measured in a self-report by the subjects.
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8 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。
合作者
调查人员
- 首席研究员：Barbara Vickrey, MD, MPH、University of California, Los Angeles
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
- Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Guterman JJ, Gross-Schulman SG, Beanes S, Jones AS, Liu H, Ettner SL, Saver JL, Vickrey BG. Randomized, controlled trial of an intervention to enable stroke survivors throughout the Los Angeles County safety net to "stay with the guidelines". Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):229-34. doi: 10.1161/CIRCOUTCOMES.110.951012.
- Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Barry F, Douglas SM, Hudson L, Ayala-Rivera M, Guterman JJ, Gross-Schulman S, Beanes S, Jones AS, Liu H, Vickrey BG. Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003228. doi: 10.1161/CIRCOUTCOMES.116.003228.
- Richards A, Jackson NJ, Cheng EM, Bryg RJ, Brown A, Towfighi A, Sanossian N, Barry F, Li N, Vickrey BG. Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk. Stroke. 2020 May;51(5):1563-1569. doi: 10.1161/STROKEAHA.119.027160. Epub 2020 Mar 23.
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1月1日
初级完成 (实际的)
2013年9月1日
研究完成 (实际的)
2013年9月1日
研究注册日期
首次提交
2009年3月12日
首先提交符合 QC 标准的
2009年3月12日
首次发布 (估计)
2009年3月13日
研究记录更新
最后更新发布 (实际的)
2018年6月6日
上次提交的符合 QC 标准的更新
2018年6月2日
最后验证
2018年6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.
Care Management的临床试验
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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的
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Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
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University Health Network, Toronto招聘中淋巴瘤 | 淋巴增生性疾病 | 乳腺癌一期 | 乳腺癌二期 | 结直肠癌 II 期 | 结直肠癌 III 期 | 乳腺癌三期 | 结直肠癌 I 期 | 头颈癌 III 期 | 乳腺癌，0 期 | 头颈癌 I 期 | 头颈癌 II 期加拿大
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Emory UniversityFoundation for Physical Therapy, Inc.完全的