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Effect of Intervention to Improve Stroke Recognition

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Olajide Williams, Columbia University
ClinicalTrials.gov Identifier:
NCT01497886
First received: December 16, 2011
Last updated: October 17, 2012
Last verified: October 2012

December 16, 2011
October 17, 2012
March 2011
March 2016   (final data collection date for primary outcome measure)
  • Stroke Symptom and Response Knowledge Assessment (student). [ Time Frame: Up to 3 days from baseline ] [ Designated as safety issue: No ]
    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 RE stroke symptoms. [ Time Frame: Up to 7 days from baseline ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01497886 on ClinicalTrials.gov Archive Site
  • Assessment of events, latency to arrival at the emergency room. [ Time Frame: 12 months from completion, and every 12 months afterwards ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 months after participation ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effect of Intervention to Improve Stroke Recognition
Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition

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.

Hypotheses:

Hypothesis 1. No differences in baseline knowledge will exist between the parents assigned to the intervention and control arms or between the children assigned to the intervention and control arms.

Hypothesis 2. Children in the intervention arm will demonstrate greater knowledge immediately after and at three months after the intervention concerning stroke symptom identification and response compared to those in the control arm.

Hypothesis 3. Compared to students in the Control condition, children in the intervention arm will be more likely to communicate stroke information to their parents (assessed at 1-week follow-up).

Hypothesis 4. In homes in which such communication has been enacted, parents in schools assigned to the intervention arm will demonstrate greater ability to name the symptoms of stroke and appropriate action, compared to their baseline knowledge, at 1 week and at 3 months follow-up, compared to parents in the control arm.

Significance: 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 cost3; 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.

Innovation: 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.

Primary Aims. The investigators propose to conduct a randomized controlled trial (RCT) with two arms: HHS Intervention and control, in 14 public schools in New York City, to evaluate the effect of the HHS intervention on:

  1. The children's' ability to name the cardinal symptoms of stroke, and the recommended action, at three months following end of the intervention. (This will provide a replication of our first trial).
  2. The likelihood that children exposed to the HHS intervention will communicate, or attempt to communicate, the content to one or more persons in their household.
  3. In homes in which such communication has occurred, the parent's ability to name the cardinal symptoms of stroke, and the recommended action, at 1 week and 3-months following end of the intervention. Secondary Aim: The average annual age-adjusted stroke incidence rate among Blacks in New York City (northern Manhattan) at age > 20, per 100,000 persons is 223, double the rate seen in whites. Although the incidence of stroke is high, it is beyond the scope of this trial to provide sufficient statistical power to assess the effect of the intervention on the interval between recognition (whether self or otherwise) and arrival at the emergency room. However, we will collect follow-up data (minimum 2year) to observe the trend.
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Stroke
  • Behavioral: Hip Hop Stroke educational program
    Three one-hour sessions, conducted over three consecutive days
  • Behavioral: 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).
  • 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.
    Intervention: 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).
    Intervention: Behavioral: Nutrition Education program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
3213
Not Provided
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • School located in Harlem, New York.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01497886
AAAF3455, 1R01NS067443-01A1
Yes
Olajide Williams, Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Olajide A Williams, MD MS Columbia University
Columbia University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP