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临床试验/NCT03848364
NCT03848364已完成不适用

Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention

Columbia University1 个研究点 分布在 1 个国家目标入组 1,706 人开始时间: 2015年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,706
试验地点
1
主要终点
Change in Stroke Literacy Score

研究概览

简要总结

This study aims to disseminate Hip Hop Stroke 2.0 (HHS2.0) to a more heterogeneous (urban, suburban, and rural population) via NYS Stroke Centers through a partnership with the New York State Department of Health (NYSDOH) Stroke Designation Program. This digital program is a second part to an original Hip Hop Stroke program where study showed effectiveness at communicating stroke awareness. In this study, the investigator proposes to intervene in school classrooms with the Hip Hop Stroke 2.0 (HHS2.0) digital program, geared towards children aged 9 to 11 years.

Primary Aims:

Aim 1: To identify contextual factors, such as barriers and facilitators, that influence uptake of the HHS program in a new, heterogeneous sample at the Stroke Center and local school levels.

Hypothesis 1: Contextual factors at the Stroke Center and local school levels will lead to differential uptake of HHS.

Aim 2: To determine whether Stroke Center implementation of the HHS program leads to increased stroke literacy of local students by cross-validating outcomes with the results of our Randomized Clinical Trial.

Hypothesis 2: Stroke Center implementation will lead to increased stroke literacy of local students.

Secondary Aims:

Aim 3: To assess the determinants of high performance implementation and effectiveness under real world practice conditions.

Aim 4: To evaluate the costs associated with HHS program implementation.

详细描述

Despite effective Acute Stroke Treatment, fewer than 10% of patients in the United States receive them. The largest barrier to this treatment are pre-hospital delays which include limited to no, knowledge of stroke signs and symptoms and the intent seek care. While there is abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures).

A mere 7% of ischemic stroke events in the US receive thrombolysis (t-PA) therapy1 due to delayed hospital arrival, most often related to the failure to recognize stroke symptoms and to call 911 immediately. Efforts to improve the public's stroke literacy have been driven by mass media stroke education campaigns that include public service announcements and print advertising. However, these efforts have failed to have an effect on 911 use (the major determinant of early hospital arrival) beyond the funding period for the specific media campaign. Stroke Centers may represent more sustainable channels for public stroke education initiatives promoting the use of ambulance services.

State Departments of Health and the Joint Commission regulate Stroke Center hospitals through an accreditation process that requires the fulfillment of certain stroke care measures. Notably, one of these regulatory requirements is community stroke education by the hospital; however, these are underdeveloped, and lack guidelines and evaluation metrics. Consequently, stroke education efforts by Stroke Centers are often poorly delivered and do not use evidence-based approaches.

The program helps schools fulfill NYS health education requirements through its primordial prevention modules. Children are also taught to teach stroke information to their parents/caregivers. HHS2.0 has shown to be effective in the real world setting through several studies, including an Randomized Clinical Trial (RCT) involving more than 3,000 predominantly Black and Hispanic urban school children aged 9-11 years. These studies found that children can and will: (1) learn how to recognize stroke, including self-efficacy for calling 911 when they witness stroke, and retain this knowledge for at least 15 months, (2) communicate stroke literacy successfully to their parents and grandparents who retain this knowledge for at least 3 months, and (3) actually call 911 when they witness stroke symptoms occurring in their homes or community.

This project is an outgrowth of our previously funded RCT (R01NS067443), in which we developed and established the effectiveness of a novel intervention to teach economically challenged minority residents of New York City to recognize stroke symptoms and know the correct response - call 911 (stroke literacy).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Schools located in the 47 hospital (stroke center) geographic catchment areas
  • Schools with 4th and/or 5th grade classes and have ascertained the following: student bodies have at least 50 students in each of these grades, diverse socio-demographic NYS communities, and computer resources / internet access required for the implementation of the HHS program.

排除标准

  • Special education school with a student body comprised of those with learning disabilities.

结局指标

主要结局

Change in Stroke Literacy Score

时间窗: Baseline, at least 3 days from baseline

The Investigator will assess stroke literacy among 4th and 5th grade students with the validated Stroke Literacy Action Measure using a pre-post- test design. Literacy will be determined by percentage of questions answered correctly. The greater percentage correct indicates a better outcome.

次要结局

  • Average total cost associated with program implementation(Baseline, up to 2 years)
  • Average number of barriers influencing program uptake(Baseline, at least 1 year from baseline)
  • Average number of facilitators influencing program uptake(Baseline, at least 1 year from baseline)
  • Average number of determinants yielding high performance implementation and effectiveness(Baseline, up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olajide Williams

Associate Professor of Neurology

Columbia University

研究点 (1)

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