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

May 31, 2024 updated by: Olajide Williams, Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

1706

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hip Hop Stroke 2.0 intervention group
Students in 4th and 5th grade will receive the intervention, Hip Hop Stroke 2.0, disseminated and implemented by local Stroke Centers - uses a framework of Child-Mediated Health Communication to make children "stroke literate" and then empower these stroke literate students with the tools required to successfully communicate actionable stroke knowledge (recognition of stroke symptoms and the urgency of calling 911) to their parents and grandparents at home.
HHS2.0 is an innovative, multimedia program, a brief 3-hour (1hr/day for 3 days), school-based intervention designed to educate at-risk populations concerning stroke symptoms and calling 911 immediately in the event they occur (stroke literacy). HHS2.0 is accessed and delivered via a web link online as self-administered, interactive modules that target 4th and 5th grade children in the school system (ages 9-11) using narrative cartoons and multimedia games.
Other Names:
  • HHS2.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Stroke Literacy Score
Time Frame: 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.
Baseline, at least 3 days from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average number of barriers influencing program uptake
Time Frame: Baseline, at least 1 year from baseline
The Investigator will find the average rate of factors influencing program update through the use of the Consolidated Framework for Implementation (CFIR). The CFIR will be measured by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate these averages.
Baseline, at least 1 year from baseline
Average number of facilitators influencing program uptake
Time Frame: Baseline, at least 1 year from baseline
The Investigator will find the average rate of factors influencing program update through the use of the Consolidated Framework for Implementation (CFIR). The CFIR will be measured by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate these averages.
Baseline, at least 1 year from baseline
Average number of determinants yielding high performance implementation and effectiveness
Time Frame: Baseline, up to 2 years
Using data from Aim 1 and Aim 2, the Investigator will analyze contextual data from each Stroke Center in relation to the data generated from RE-AIM variables. The Investigator will assess the average number of factors/elements influencing the adoption, implementation, and maintenance of the intervention at the Stroke Center and the local school level
Baseline, up to 2 years
Average total cost associated with program implementation
Time Frame: Baseline, up to 2 years
The Investigator will conduct cost analyses from two complementary perspectives: 1) implementing agencies (primary cost analysis) and 2) society as a whole (secondary cost analysis). The Investigator will first estimate costs, and variations therein, based on the experience of participating Stroke Centers and schools (implementing agencies). The Investigator will develop estimates of the total cost of the HHS program, its key components and activities, and costs per participant using the resource cost method and look at the average totals.
Baseline, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olajide Williams, MD, MS, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2015

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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