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OpenTrials
Completed

NCT Number: NCT01909271

Tailored Approaches to Stroke Health Education

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.

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Key information

Age range

34 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stroke Education Film Viewing

Behavioral

A novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-min films (in English and Spanish), in minority populations in New York City.

Stroke Education Pamphlet Exposure

Other

"Usual Care": Stroke Education pamphlet and brochure distribution.

Primary outcomes

  1. 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

  1. Score on Stroke Action Test

    Time frame: Within six months 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.

  2. Score on Stroke Action Test

    Time frame: Within one year 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.

Other outcomes

  1. Time to emergency room after suffering a stroke

    Time frame: Up to 3.5 years post-intervention

    This measures the time in getting to the emergency room after having suffered a stroke.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: TASHE

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jul 26, 2013
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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