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Effect of Intervention to Improve Stroke Recognition

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Hop Stroke educational program
Nutrition Education program
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Children, Hip Hop Stroke, New York City

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hip Hop Stroke educational program

Nutrition Education program

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 16, 2011
Last Updated
July 13, 2020
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01497886
Brief Title
Effect of Intervention to Improve Stroke Recognition
Official Title
Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
June 23, 2015 (Actual)
Study Completion Date
June 2016 (Actual)

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
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Children, Hip Hop Stroke, New York City

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip Hop Stroke educational program
Arm Type
Active Comparator
Arm Description
Hip Hop Stroke is a school-based educational program that incorporates educational hip hop music and two cartoons to communicate stroke knowledge to children.
Arm Title
Nutrition Education program
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Hip Hop Stroke educational program
Intervention Description
Three one-hour sessions, conducted over three consecutive days
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Stroke Symptom and Response Knowledge Assessment (student)
Description
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
Title
Assessment of child's communication to parent regarding stroke symptoms.
Description
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 Outcome Measure Information:
Title
Assessment of events, latency to arrival at the emergency room.
Description
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
Title
Longitudinal Stroke Symptom and Response Knowledge Assessment (student)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olajide A. Williams, MD MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22875089
Citation
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.
Results Reference
background
PubMed Identifier
22033995
Citation
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.
Results Reference
background
PubMed Identifier
29567762
Citation
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.
Results Reference
derived

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Effect of Intervention to Improve Stroke Recognition

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