NCT02346266

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

January 20, 2015

Last Update Submit

January 23, 2015

Conditions

Stroke

Keywords

StrokeStroke PreventionChildrenEducation

Outcome Measures

Primary Outcomes (1)

  • Child Improved Stroke Literacy

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

    3 weeks

Secondary Outcomes (1)

  • Adult Improved Stroke Literacy

    3 weeks

Study Arms (2)

SMART

ACTIVE COMPARATOR

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.

Other: SMART Education

Usual Care

NO INTERVENTION

This group will not receive stroke education.

Interventions

SMART EducationOTHER
SMART

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High-school student

You may not qualify if:

  • Not a high-school student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

November 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01