NCT03848364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,706

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

7.2 years

First QC Date

February 19, 2019

Last Update Submit

May 31, 2024

Conditions

Keywords

StrokeEducationHip Hop StrokeCommunityNutritionSchoolsStroke Centers

Outcome Measures

Primary Outcomes (1)

  • Change in Stroke Literacy Score

    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 Outcomes (4)

  • 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

  • Average total cost associated with program implementation

    Baseline, up to 2 years

Study Arms (1)

Hip Hop Stroke 2.0 intervention group

EXPERIMENTAL

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.

Behavioral: Hip Hop Stroke 2.0

Interventions

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.

Also known as: HHS2.0
Hip Hop Stroke 2.0 intervention group

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olajide Williams, MD, MS

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Stroke Centers who agree to participate will designate a Stroke coordinator who will recruit at least 2 schools from their area with 4th and/or 5th grades. Coordinators will receive a customizable electronic training package to introduce content, and recruit strategies to engage schools. They will in turn coordinate with School Champions (school designated member), who will receive program training, to implement the program. School Champion will be responsible for the distribution of Opt-Out consent forms, scheduling programming (including computer use), and coordinating with the Stroke Champion and research staff. Regarding maintenance, Stroke Coordinators and School Champions will complete and exit survey, and to promote annual implementation in recruited schools.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 20, 2019

Study Start

December 17, 2015

Primary Completion

February 28, 2023

Study Completion

May 31, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations