- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497886
Effect of Intervention to Improve Stroke Recognition
Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- School located in Harlem, New York.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Three one-hour sessions, conducted over three consecutive days
|
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke Symptom and Response Knowledge Assessment (student)
Time Frame: Up to 3 days from baseline
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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.
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Up to 3 days from baseline
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Assessment of child's communication to parent regarding stroke symptoms.
Time Frame: Up to 7 days from baseline
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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.
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Up to 7 days from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of events, latency to arrival at the emergency room.
Time Frame: 12 months from completion, and every 12 months afterwards
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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.
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12 months from completion, and every 12 months afterwards
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Longitudinal Stroke Symptom and Response Knowledge Assessment (student)
Time Frame: 3 months after participation
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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.
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3 months after participation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olajide A. Williams, MD MS, Columbia University
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAF3455
- 1R01NS067443-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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