Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)
2019年12月6日 更新者：Catherine A. Sarkisian、University of California, Los Angeles
Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers
Stroke is a cruel disease that disproportionately kills and disables African-Americans, Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at particularly high risk. There is a higher incidence of hemorrhagic stroke in African Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical need therefore exists for a sustainable and scalable mechanism to disseminate culturally-tailored stroke knowledge/prevention education in community-based settings where large numbers of these high-risk ethnic minority older adult groups are regularly served, such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation (16 of which are in Los Angeles alone).
The overall objective of the proposed study is to develop and test the implementation of a training program for case managers at senior centers to implement a stoke knowledge/prevention education program among four high-risk ethnic minority older adult groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a culturally-tailored case manager training curriculum, implement the training at 4 community-based sites, and evaluate the training model using a randomized wait-list controlled trial (n=244) testing the hypothesis that training case managers will decrease older adult participants' stroke risk in a sustainable fashion through increasing their preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3 months).
Findings will inform similar community-academic partnership efforts around stroke and other disease-specific prevention research/interventions; they will also determine next steps in terms of whether this case manager-centric model can be scaled up and deployed in other community-based settings.
研究概览
详细说明
As many as 30% of ischemic strokes in the U.S. population can be attributed to physical inactivity.
With the goal of eliminating racial/ethnic stroke disparities, this interdisciplinary team proposes to develop, implement, and test a culturally-tailored behavioral intervention to reduce stroke risk (primary prevention) by increasing physical activity (walking) for 4 different racial/ethnic groups (Korean-Americans, Chinese-Americans, African-Americans and Latinos) in Los Angeles community senior centers.
The intervention combines stroke and stroke risk factor knowledge (using materials developed by the American Heart Association and American Stroke Association) with theoretically-grounded behavioral change techniques and focuses on reducing stroke risk by increasing physical activity (walking).
The study team will conduct focus groups (n=144) to identify culture-specific beliefs about stroke and stroke risk factors, to assess the feasibility and acceptability of the intervention, and will work with Community Action Panels to culturally-tailor the intervention.
The intervention will consist of 4 weeks of twice-weekly 1-hour group sessions implemented at 4 community senior centers by trained case managers who are part of the regular senior center staff and supported by congressionally-mandated Older Americans Act Title III funding.
The project team will test the effectiveness of the intervention in a randomized wait-list controlled trial (n=240) testing the hypothesis that the intervention will increase mean steps/day (measured by pedometer) at 1 and 3 months, and that the increase will be mediated by changes in stroke/stroke risk knowledge and self-efficacy.
Blood pressure will be examined as a secondary outcome.
In collaboration with the SPIRP Biomarker Collection & Analysis Core, the team will collect biological specimens (finger pricks) to explore the relationship between the intervention and biological markers of health; they will also explore the relationship between the intervention and healthcare seeking or taking medications to control stroke risk factors.
The team will evaluate the barriers and facilitators of successfully integrating the intervention into the senior centers in order to inform large-scale implementation of the culturally-tailored stroke risk factor reduction/walking intervention.
研究类型
介入性
注册 (实际的)
240
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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California
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Los Angeles、California、美国、90012
- Chinatown Service Center
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Los Angeles、California、美国、90057
- St. Barnabas Senior Services
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Montebello、California、美国、90640
- Mexican American Opportunity Foundation
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Watts、California、美国、90059
- Watts Labor Community Action Committee
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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
60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:
- age 60 years and older
- reported history of high blood pressure
Exclusion Criteria:
- younger than 60 years of age
- not self-identifying as the racial-ethnic group for the intervention planned at that site
- inability to communicate verbally in the appropriate language in a group setting (either due to lack of language skills, hearing impairment, or other disability)
- inability to sit in a chair and participate in a 1-hour discussion session
- inability to walk (the use of assistive devices such as canes and walkers is not an exclusion criterion)
- not available to attend the baseline data collection session and subsequent weekly intervention sessions
- plans to move away from the region during the next 6 months
- lacking cognitive capacity to provide informed consent to participate
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Walking Intervention
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4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions. The intervention will provide the knowledge necessary to improve stroke risk factors. Case manager group leaders will teach that seeing a healthcare provider regularly and monitoring blood pressure prevents strokes; all participants will be provided with the National Institute on Aging booklet, "How to Talk to your Doctor" and the contact information for their healthcare provider. Participants will be given a pedometer and be trained to use it to measure steps, with the goal of reaching 10,000 steps each day. The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to "old age." |
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无干预：Wait-list control
After 3 months, participants will be invited to participate in the intervention.
No additional measures or outcomes will be recorded.
|
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 |
|---|---|---|
|
Change from Baseline in Mean steps/day at 3 months
大体时间：3 months
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Measured via pedometer.
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3 months
|
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Change from Baseline in Mean Steps/day at 1 month
大体时间：1 month
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Measured via pedometer.
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1 month
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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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Stroke and stroke risk factor knowledge
大体时间：baseline, 1 month, and 3 months
|
Stroke Action Survey (STAT)
|
baseline, 1 month, and 3 months
|
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Self Efficacy
大体时间：baseline, 1 month, and 3 months
|
Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
|
baseline, 1 month, and 3 months
|
|
Blood pressure
大体时间：baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
|
BMI (kg/m^2)
大体时间：baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
|
LDL cholesterol
大体时间：baseline and 3 months
|
Point-of-service CardioChek meter
|
baseline and 3 months
|
|
Glycosylated hemoglobin
大体时间：baseline and 3 months
|
Measured through finger prick.
|
baseline and 3 months
|
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c-reactive protein
大体时间：baseline and 3 months
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measured through finger prick
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baseline and 3 months
|
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Healthcare seeking
大体时间：baseline and at 3 months
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Measure visits to a healthcare provider via survey.
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baseline and at 3 months
|
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Medications to control stroke risk factors
大体时间：baseline and at 3 months
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Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
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baseline and at 3 months
|
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Socioeconomic status
大体时间：baseline
|
baseline
|
|
|
Acculturation
大体时间：Baseline
|
Modified Marin Acculturation Scale
|
Baseline
|
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Medical comorbidities
大体时间：Baseline
|
Katz/Charlson Comorbidity index
|
Baseline
|
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Social support/network
大体时间：Baseline, 1 month, 3 months
|
Interpersonal Support Evaluation List (ISEL)
|
Baseline, 1 month, 3 months
|
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Neighborhood Walkability
大体时间：baseline
|
Neighborhood Environment Walkability Scale (NEWS)
|
baseline
|
|
Health-related QOL
大体时间：baseline, 1 month, and 3 months
|
Medical outcomes study, Short Form (SF) 12
|
baseline, 1 month, and 3 months
|
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Depressive symptoms
大体时间：baseline, 1 month, and 3 months
|
Patient Health Questionnaire
|
baseline, 1 month, and 3 months
|
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Disability
大体时间：baseline, 1 month, and 3 months
|
Activities of Daily Living (ADL) Summary scale survey
|
baseline, 1 month, and 3 months
|
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。
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
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- Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.
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- Jones SP, Jenkinson AJ, Leathley MJ, Watkins CL. Stroke knowledge and awareness: an integrative review of the evidence. Age Ageing. 2010 Jan;39(1):11-22. doi: 10.1093/ageing/afp196. Epub 2009 Nov 6.
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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
2014年10月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2014年6月30日
首先提交符合 QC 标准的
2014年7月1日
首次发布 (估计)
2014年7月3日
研究记录更新
最后更新发布 (实际的)
2019年12月9日
上次提交的符合 QC 标准的更新
2019年12月6日
最后验证
2019年12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.