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SMART (School-aged Children Making Healthy Choices And Recognizing sTroke) (SMART)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMART Education
Sponsored by
Los Amigos Research and Education Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Stroke Prevention, Children, Education

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • High-school student

Exclusion Criteria:

  • Not a high-school student

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    SMART

    Usual Care

    Arm Description

    The intervention group of school-aged children will receive education on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.

    This group will not receive stroke education.

    Outcomes

    Primary Outcome Measures

    Child Improved Stroke Literacy
    A school-based stroke literacy program targeting children in grades 9th through 12th will be successful in improving stroke literacy.

    Secondary Outcome Measures

    Adult Improved Stroke Literacy
    If school-aged children, grades 9th through 12th are taught the F.A.S.T. acronym, additional signs and symptoms of stroke and the immediate activation of EMS by calling 911, they will improve the stroke literacy of their parents.

    Full Information

    First Posted
    January 20, 2015
    Last Updated
    January 23, 2015
    Sponsor
    Los Amigos Research and Education Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02346266
    Brief Title
    SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)
    Acronym
    SMART
    Official Title
    SMART (School-aged Children Making Healthy Choices And Recognizing sTroke): A Pilot Trial of a Stroke Awareness Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Los Amigos Research and Education Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A stroke awareness program for school-aged children to learn the signs/symptoms of stroke, teach their parents and make healthy life-style choices.
    Detailed Description
    To educate school-aged children, grades 9th through 12th on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911. To improve adults' stroke literacy through educating their children in grades 9th through 12th.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Stroke, Stroke Prevention, Children, Education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SMART
    Arm Type
    Active Comparator
    Arm Description
    The intervention group of school-aged children will receive education on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    This group will not receive stroke education.
    Intervention Type
    Other
    Intervention Name(s)
    SMART Education
    Primary Outcome Measure Information:
    Title
    Child Improved Stroke Literacy
    Description
    A school-based stroke literacy program targeting children in grades 9th through 12th will be successful in improving stroke literacy.
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Adult Improved Stroke Literacy
    Description
    If school-aged children, grades 9th through 12th are taught the F.A.S.T. acronym, additional signs and symptoms of stroke and the immediate activation of EMS by calling 911, they will improve the stroke literacy of their parents.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: High-school student Exclusion Criteria: Not a high-school student

    12. IPD Sharing Statement

    Learn more about this trial

    SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)

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