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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03848364
Study type Interventional
Source Columbia University
Contact Janhavi Mallaiah, MBBS, MPH
Phone 212-342-0715
Email jm4498@cumc.columbia.edu
Status Recruiting
Phase N/A
Start date December 17, 2015
Completion date December 2023

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