Stroke Clinical Trial
Official title:
Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
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.
Status | Recruiting |
Enrollment | 4700 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 11 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, at least 1 year from baseline | |
Secondary | 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. | Baseline, at least 1 year from baseline | |
Secondary | 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 | Baseline, up to 2 years | |
Secondary | 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. | Baseline, up to 2 years |
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