Effect of Intervention to Improve Stroke Recognition
Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition
2 other identifiers
interventional
4,614
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Mar 2011
Longer than P75 for not_applicable stroke
1 active site
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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 15, 2020
July 1, 2020
4.3 years
December 16, 2011
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to 3 days from baseline
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.
Up to 7 days from baseline
Secondary Outcomes (2)
Assessment of events, latency to arrival at the emergency room.
12 months from completion, and every 12 months afterwards
Longitudinal Stroke Symptom and Response Knowledge Assessment (student)
3 months after participation
Study Arms (2)
Hip Hop Stroke educational program
ACTIVE COMPARATORHip Hop Stroke is a school-based educational program that incorporates educational hip hop music and two cartoons to communicate stroke knowledge to children.
Nutrition Education program
PLACEBO COMPARATORThe 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).
Interventions
Three one-hour sessions, conducted over three consecutive days
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).
Eligibility Criteria
You may qualify if:
- th-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.
You may not qualify if:
- School located in Harlem, New York.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (3)
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.
PMID: 22875089BACKGROUNDWilliams 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.
PMID: 22033995BACKGROUNDWilliams 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.
PMID: 29567762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olajide A. Williams, MD MS
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 23, 2011
Study Start
March 1, 2011
Primary Completion
June 23, 2015
Study Completion
June 1, 2016
Last Updated
July 15, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share