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Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)

2018年9月10日 更新者：VA Office of Research and Development

The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration.

This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the Veteran Stroke Prevention Program takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/Department of Defense, American Heart Association, and the Joint Commission stroke care guidelines and improve their quality of stroke care.

Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.

研究类型

介入性

注册 (实际的)

174

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

  • 美国
    • Indiana
      • Indianapolis、Indiana、美国、46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    • Texas
      • Houston、Texas、美国、77030
        • Michael E. DeBakey VA Medical Center, Houston, TX

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:

  • Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center;
  • willing to participate;
  • access to telephone;
  • speaks and understands English;
  • no severe cognitive impairments;
  • life expectancy of at least 6 mos;
  • willingness to follow-up in Veterans Administration outpatient care.

Exclusion Criteria:

  • Severe aphasia or cognitive impairment;
  • active alcohol or substance abuse;
  • cannot or unwilling to participate;
  • does not speak or understand English;
  • life expectancy less than 6 mos;
  • no access to telephone;
  • no Veterans Administration outpatient follow-up.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm 1 Secondary Risk Factor Management
Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
行为的：Physician stroke guideline adherence
Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
行为的：Stroke Self Management
Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA
安慰剂比较：Attention Control Group
Received Phone Calls from Staff to Control for Attention
其他：Attention Control Group
Received Phone Calls from Staff to Control for Attention

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
Stroke Specific Health Related Quality of Life
大体时间：6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
  • Stroke Specifc, Health Related Quality of Life (SSQoL)
  • Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.
  • Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.

We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05.
6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
Self-Efficacy to Manage Stroke Symptoms
大体时间：6 months
Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.
6 months

次要结果测量

结果测量
措施说明
大体时间
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
大体时间：baseline, 6 months
  • Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)
  • Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%
baseline, 6 months
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
大体时间：baseline, 6 months
  • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).
  • Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%.
baseline, 6 months
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
大体时间：Baseline, 6 months
  • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)
  • Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%.
Baseline, 6 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。

赞助

VA Office of Research and Development

合作者

Indiana 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

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

2009年1月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2006年7月18日

首先提交符合 QC 标准的

2006年7月18日

首次发布 (估计)

2006年7月21日

研究记录更新

最后更新发布 (实际的)

2018年10月11日

上次提交的符合 QC 标准的更新

2018年9月10日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IAB 05-297
  • 0608-01B (其他赠款/资助编号：US Veterans Health Administration)
  • 1009001684 (其他赠款/资助编号：US Veterans Health Administration)

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.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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