Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Hop Stroke 2.0
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Stroke, Education, Hip Hop Stroke, Community, Nutrition, Schools, Stroke Centers
Eligibility Criteria
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.
Sites / Locations
- Columbia University Irving Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hip Hop Stroke 2.0 intervention group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Average number of barriers influencing program uptake
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.
Average number of facilitators influencing program uptake
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.
Average number of determinants yielding high performance implementation and effectiveness
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
Average total cost associated with program implementation
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.
Full Information
NCT ID
NCT03848364
First Posted
February 19, 2019
Last Updated
August 31, 2023
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT03848364
Brief Title
Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
Official Title
Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Education, Hip Hop Stroke, Community, Nutrition, Schools, Stroke Centers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hip Hop Stroke 2.0 intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hip Hop Stroke 2.0
Other Intervention Name(s)
HHS2.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Stroke Literacy Score
Description
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.
Time Frame
Baseline, at least 3 days from baseline
Secondary Outcome Measure Information:
Title
Average number of barriers influencing program uptake
Description
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.
Time Frame
Baseline, at least 1 year from baseline
Title
Average number of facilitators influencing program uptake
Description
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.
Time Frame
Baseline, at least 1 year from baseline
Title
Average number of determinants yielding high performance implementation and effectiveness
Description
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
Time Frame
Baseline, up to 2 years
Title
Average total cost associated with program implementation
Description
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.
Time Frame
Baseline, up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janhavi Mallaiah, MBBS, MPH
Phone
212-342-0715
Email
jm4498@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Williams
Email
maw2242@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olajide Williams, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janhavi Mallaiah, MBBS, MPH
Phone
212-342-0715
Email
jm4498@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Mark Williams
Email
maw2242@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Olajide A. Williams, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
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