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Clinical Trials/NCT01909271
NCT01909271
Completed
N/A

Tailored Approaches to Stroke Health Education

Columbia University2 sites in 1 country290 target enrollmentApril 16, 2014
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Columbia University
Enrollment
290
Locations
2
Primary Endpoint
Score on Stroke Action Test
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team. Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC). Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.

Detailed Description

Stroke is the leading cause of adult disability and costs U.S. taxpayers \>$60 billion annually. Interventions designed to educate patients to seek treatment sooner when a stroke occurs may increase low rates of treatment with thrombolysis (current rates 3% national average). Thrombolysis can increase the odds of minimal to zero disability from stroke if emergency medical system response times and in-hospital response times are optimized (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and Hispanic Americans have higher stroke incidence compared to Whites and are less likely to receive thrombolysis for acute stroke. The latency to hospital arrival is largely dependent on patients' recognition of stroke symptoms, and immediate presentation to the emergency department. The investigators have found very low stroke literacy rates among Blacks and Hispanics compared to Whites, which may, in part, be responsible for disparities in acute stroke treatment.

Registry
clinicaltrials.gov
Start Date
April 16, 2014
End Date
December 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Olajide Williams

Chief of Staff of Neurology Associate Professor of Clinical Neurology

Columbia University

Eligibility Criteria

Inclusion Criteria

  • No prior history of stroke;
  • High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
  • Over age 34 years at onset of intervention (we have selected this age cut off due to the large increase in stroke incidence among minority groups at age 34 );
  • Self-identified as Black or Hispanic; and
  • Member of a church congregation who lives in a household with a telephone.

Exclusion Criteria

  • Participant is unable to give consent;
  • A modified Rankin score \> 4 at baseline;
  • history of dementia; and
  • terminal illness, or other medical illness resulting in mortality \< 1 year.

Outcomes

Primary Outcomes

Score on Stroke Action Test

Time Frame: Within one hour of stroke education intervention.

The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms. For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day. For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points. The total score is reported as percent of correct responses. Scores range from 0% to 100% with a higher score indicating a better outcome.

Secondary Outcomes

  • Score on Stroke Action Test(Within one year of stroke education intervention.)

Study Sites (2)

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