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
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: Hip Hop Stroke educational program
Behavioral: Nutrition Education program
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial Effect of Novel Intervention to Improve Stroke Symptom Recognition

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 3213
Study Start Date: March 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
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).

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497886

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Olajide A Williams, MD MS Columbia University
  More Information

Publications:
Responsible Party: Olajide Williams, Associate Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT01497886     History of Changes
Other Study ID Numbers: AAAF3455, 1R01NS067443-01A1
Study First Received: December 16, 2011
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Columbia University:
Stroke
Children
Hip Hop Stroke
New York City

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 01, 2014