Tailored Approaches to Stroke Health Education

NCT ID: NCT01909271

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

Participants will receive education through a novel program called Stroke Education Film Viewing.

Group Type EXPERIMENTAL

Stroke Education Film Viewing

Intervention Type 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.

Usual Care Group

Participants will receive education through Stroke Education Pamphlet Exposure.

Group Type OTHER

Stroke Education Pamphlet Exposure

Intervention Type OTHER

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

Interventions

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Stroke Education Film Viewing

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.

Intervention Type BEHAVIORAL

Stroke Education Pamphlet Exposure

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. No prior history of stroke;
2. High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
3. 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 );
4. Self-identified as Black or Hispanic; and
5. Member of a church congregation who lives in a household with a telephone.

Exclusion Criteria

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

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Olajide Williams

Chief of Staff of Neurology Associate Professor of Clinical Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olajide. A Williams, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center, Neurological Institute

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Williams O, Teresi J, Eimicke JP, Abel-Bey A, Hassankhani M, Valdez L, Gomez Chan L, Kong J, Ramirez M, Ravenell J, Ogedegbe G, Noble JM. Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1211-1218. doi: 10.1001/jamaneurol.2019.1741.

Reference Type DERIVED
PMID: 31260028 (View on PubMed)

Ravenell J, Leighton-Herrmann E, Abel-Bey A, DeSorbo A, Teresi J, Valdez L, Gordillo M, Gerin W, Hecht M, Ramirez M, Noble J, Cohn E, Jean-Louis G, Spruill T, Waddy S, Ogedegbe G, Williams O. Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial. Trials. 2015 Apr 19;16:176. doi: 10.1186/s13063-015-0703-4.

Reference Type DERIVED
PMID: 25927452 (View on PubMed)

Other Identifiers

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1U54NS081765-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAK5853

Identifier Type: -

Identifier Source: org_study_id

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