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CompletedNCT01497886Updated Jul 15, 2020

Effect of Intervention to Improve Stroke Recognition

An interventional study of Hip Hop Stroke educational program and Nutrition Education program in Stroke, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Columbia University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2011, registered Dec 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
4,614
Allocation
Randomized
Ages
7 Years and older
Sex
All
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Study summary

Despite the abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures). Expensive mass media stroke education campaigns are not sustainable for this purpose, particularly in economically disadvantaged populations. Instead, the investigators propose to intervene in school classrooms with children aged 9 to 11 years, to teach the five cardinal stroke symptoms, the correct course of action when they occur, and to highlight the potential therapeutic benefit of early hospital arrival, with the intent that the children will then educate their parents. To help accomplish this, the investigators have developed a program called Hip Hop Stroke (HHS), which is comprised of rap songs and two animated musical cartoons that incorporate stroke knowledge.

Read the detailed description

Stroke is the leading cause of serious long-term adult disability in the U.S. and third leading cause of death, and has a 2-fold greater incidence in Blacks compared to the majority Americans. Thrombolytic revascularization treatment administered within a maximum of 3 hours from symptom onset reduces morbidity, mortality and cost; however, only 3% of patients arrive at the hospital within 3 hours,4 mostly due to the public's lack of knowledge concerning stroke symptoms, and the appropriate response when they are recognized, which is to call 911. The investigators propose to reduce these delays using a novel behavioral intervention to improve symptom recognition and response in a high-risk, minority, economically disadvantaged population. Despite the abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures). Expensive mass media stroke education campaigns are not sustainable for this purpose, particularly in economically disadvantaged populations. Instead, the investigators propose to intervene in school classrooms with children aged 9 to 11 years, to teach the five cardinal stroke symptoms, the correct course of action when they occur, and to highlight the potential therapeutic benefit of early hospital arrival, with the intent that the children will then educate their parents. To help accomplish this, the investigators have developed a program called Hip Hop Stroke (HHS), which is comprised of rap songs and two animated musical cartoons that incorporate stroke knowledge.

Targeting children to intervene with their parents has been rarely and sporadically attempted in various content areas, but the interventions have used traditional teaching methods that do not engage the children, and little success has been reported. In contrast, the HHS intervention was designed in collaboration with school-aged children, children's education television/media experts, as well as public health experts, school principals, and neurologists. As a result, not only is the targeting of children for this purpose an important innovation, but so is the careful development of materials designed to appeal to them. Moreover, the investigators note that utilizing children as a "transmission vector" for carrying out interventions aimed at their parents has the potential to serve as the basis for intervention in any number of other areas, for example, medication adherence, healthy eating and weight loss, treatment of diabetes, and so on.Thus, the significance of the proposed trial addresses the public health problem under study stroke symptom identification and response as well as development and refinement of a more general model of intervention.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Children
  • Hip Hop Stroke
  • New York City
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 4,614 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 4th-6th grade children and their parents in selected elementary public schools in the same geographical region/community with similar socioeconomic status (SES) and Ethnic composition.

Exclusion criteria

Exclusion Criteria:

  • School located in Harlem, New York.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,614 participants (actual)

Study arms

  • Active comparator
    Hip Hop Stroke educational program

    Hip Hop Stroke is a school-based educational program that incorporates educational hip hop music and two cartoons to communicate stroke knowledge to children.

    Behavioral: Hip Hop Stroke educational program

  • Placebo comparator
    Nutrition Education program

    The investigators will use what they will refer to as a "usual care" control. For this purpose the investigators have selected nutrition, physical activity, and obesity education. A trained facilitator will conduct the control program in the school auditorium. The investigators will use this control method to control for "attention", i.e., having a facilitator come to the classroom for the same amount of time as in the intervention that is, 1-hour sessions on three consecutive days. The facilitator will provide focused lectures on relevant topics, and show two short, 4-minute animated films on nutrition, and physical activity. The investigator will conduct parallel pretests and post-tests on the children (same as intervention testing sequence).

    Behavioral: Nutrition Education program

Interventions

  • BehavioralHip Hop Stroke educational program

    Three one-hour sessions, conducted over three consecutive days

  • BehavioralNutrition Education program

    The investigators will use what they will refer to as a "usual care" control. For this purpose the investigators have selected nutrition, physical activity, and obesity education. A trained facilitator will conduct the control program in the school auditorium. The investigators will use this control method to control for "attention", i.e., having a facilitator come to the classroom for the same amount of time as in the intervention that is, 1-hour sessions on three consecutive days. The facilitator will provide focused lectures on relevant topics, and show two short, 4-minute animated films on nutrition, and physical activity. The investigator will conduct parallel pretests and post-tests on the children (same as intervention testing sequence).

06

What researchers measure

Primary outcomes

  1. Stroke Symptom and Response Knowledge Assessment (student)

    Knowledge of stroke prevention measures will be assessed by 8 YES/NO questions: 5 real and 3 distracters: eating lots of fruits and vegetables, exercising everyday, always taking medications given by doctor for high blood pressure/diabetes/high cholesterol, smoking avoidance or cessation, avoiding drug abuse, exercising once-a-week, eating lots of red meat, adding salt to meals.

    Time frame: Up to 3 days from baseline

  2. Assessment of child's communication to parent regarding stroke symptoms.

    This measure assesses whether the child has talked with one of the adults in the household about what the child learned in school in both the HHS and control arms concerning symptoms of stroke and correct response.

    Time frame: Up to 7 days from baseline

Secondary outcomes

  1. Assessment of events, latency to arrival at the emergency room.

    The investigators will ask the participating parents to report any diagnosis of stroke received, at 12 months, continuing through the duration of the funding period. If the parent reports a stroke,the investigators will ask for permission to conduct a chart review to confirm the stroke diagnosis, and the treatment given (especially regarding thrombolytic therapy. The investigators will also ask the patient (or family member if the patient is non verbal), who recognized the symptoms (self or other or child) and who called 911.

    Time frame: 12 months from completion, and every 12 months afterwards

  2. Longitudinal Stroke Symptom and Response Knowledge Assessment (student)

    Knowledge of stroke prevention measures will be assessed by 8 YES/NO questions: 5 real and 3 distracters: eating lots of fruits and vegetables, exercising everyday, always taking medications given by doctor for high blood pressure/diabetes/high cholesterol, smoking avoidance or cessation, avoiding drug abuse, exercising once-a-week, eating lots of red meat, adding salt to meals.

    Time frame: 3 months after participation

07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Publications

  • Williams O, DeSorbo A, Noble J, Shaffer M, Gerin W. Long-term learning of stroke knowledge among children in a high-risk community. Neurology. 2012 Aug 21;79(8):802-6. doi: 10.1212/WNL.0b013e3182661f08. Epub 2012 Aug 8. PubMed 22875089 ↗
  • Williams O, DeSorbo A, Noble J, Gerin W. Child-Mediated Stroke Communication: findings from Hip Hop Stroke. Stroke. 2012 Jan;43(1):163-9. doi: 10.1161/STROKEAHA.111.621029. Epub 2011 Oct 27. PubMed 22033995 ↗
  • Williams O, Leighton-Herrmann Quinn E, Teresi J, Eimicke JP, Kong J, Ogedegbe G, Noble J. Improving Community Stroke Preparedness in the HHS (Hip-Hop Stroke) Randomized Clinical Trial. Stroke. 2018 Apr;49(4):972-979. doi: 10.1161/STROKEAHA.117.019861. PubMed 29567762 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01497886
Lead sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Olajide Williams (Associate Professor of Neurology, Columbia University) — Principal investigator
First posted
Dec 23, 2011
Start date
Mar 2011
Primary completion
Jun 23, 2015
Completion
Jun 2016
Last update
Jul 15, 2020

Study contacts

Olajide A. Williams, MD MS
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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